HospiMedica International May 2019

V I S I T

WORLD’S

CLINICAL NEWS

Vol.37 No.2 • 4-5 / 2019

LEADER DAILY CLINICAL NEWS

ISSN 0898-7270

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New Scanner Assesses Risk of Pressure Ulcers n innovative wireless handheld device detects subepidermal moisture (SEM), identifying specific areas at increased risk for developing pressure damage.

The Bruin Biometrics SEM Scanner is designed to detect localized tissue edema and pressure induced

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CT Radiation Dose Levels Vary Across Countries new international study shows a wide variation in the radiation dose levels used for computerized tomography (CT) scans, exposing patients to unnecessary radiation. Researchers at the University of California, San Francisco (UCSF; USA; www.ucsf.edu), St.

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Dedicated MRI System Scans Neonates Inside the NICU

Image: Courtesy of Aspect Imaging

compact magnetic resonance imaging (MRI) A system designed for use

Image: The Embrace Neonatal MRI System inside a NICU

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portable, lightweight fluoroscopy and x-ray imaging device allows x-ray imaging of extremities at the point of care (POC). The Smart-Carm x-ray imaging device is a collapsible, extremely portable, batterypowered x-ray system that weighs

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Machine Learning Detects Cervical Cancer novel colposcope uses an automated visual evaluation (AVE) algorithm to detect cervical cancer from even a single image.

The MobileODT Enhanced Visual Assessment 3 (EVA3) system is a compact colposcope designed for durability and portability. Features include an ultra-bright powered light source with cross-polarization (to reduce glare); a complementary metal-oxide semiconductor Cont’d on page 22

INSIDE Industry News . . . . . . . . . 25 International Calendar . . 26

News Update . . . . . . . . . . 6 Product News . . . . . . .6-10

Autonomous MRI Solution Enables More Efficient Scans

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novel stimulation therapy restores the natural motor function of the digestive system for patients with acute gastrointestinal dysmotility (GID). The EMotion System is designed to deliver unique patterns of electrical stimulation to the esophagus using a proprietary disposable feeding tube placed by nursing staff, similar to a nasogastric feeding tube.

By accurately sequencing of the

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inside the neonatal intensive care unit (NICU), reduces the risks and time involved with transporting newborns to an external facility, as well as generating major cost savings, thereby providing MRI access from the first hours of life through the life-critical time spent within the NICU.

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Stimulation Therapy Restores Digestive Motility

Luke’s International Hospital (Tokyo, Japan; hospital.luke.ac.jp), Maastricht University Medical Center (MUMC; The Netherlands; www. mumc.nl), and other institutions conducted an observational, prospective cohort study of over two million adults CT scans performed

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novel artificial intelligence (AI) platform integrates with existing magnetic resonance imaging (MRI) scanners to enable a complete and comprehensive cardiac ischemia exam in less than 15 minutes.

The HeartVista (Los Altos, CA,

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USA; www.heartvista.com) OneClick MRI acquisition software is designed to automatically acquire standard cardiac views in as little as 10 seconds, all while the patient breathes freely. An artifact detection algorithm incorporated into the autonomous protocol Cont’d on page 5

News Update . . . . . . . . . 10 Product News . . . . . 10-14

News Update . . . . . . . . . 16 Product News . . . . . .16-20

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CT Radiation Dose Levels Vary Across Countries cont’d from cover

between November 2015 and August 2017 at 151 institutions across seven countries (Switzerland, Netherlands, Germany, United Kingdom, United States, Israel, and Japan).

The main outcome measures were mean effective doses and proportions of high dose examinations for abdomen, chest, combined chest and abdomen, and head CT, as determined by patient characteristics (sex, age, and size), type of institution (trauma center, care provision 24/7 centers, and academic or private locales), institutional practice volume, machine factors (manufacturer and model), country, and how scanners were used – before and after adjustment for patient characteristics – using hierarchical linear and logistic regression.

The results revealed that mean effective dose and the proportion of high dose examinations varied substantially across institutions. Even after adjusting for patient characteristics, wide variations in radiation doses across countries persisted, with a fourfold range in mean effective dose for abdomen CT examinations and a 17-fold range in proportion of high dose examinations. Similar variations were observed for chest and combined chest and abdomen CT, but doses for head CT varied less. In contrast, doses varied modestly by type of institution and machine characteristics. The study was published on January 2, 2018, in BMJ. “We were surprised to learn that the type of machine mattered so little; it is how the machines are used that matters, telling us that there is tremendous opportunity to lower doses, without acquiring the newest machine make and model,” said lead author Professor Rebecca Smith-Bindman, MD, of UCSF. “Our analysis of assessing the variation in dose for specific clinical indications and limited to patients scanned in a single type of machine was the most surprising and highlights this finding.”

“The variation between patients was extremely high…but dose levels could be reduced virtually overnight if there was the will to do so. There is a safety imperative to standardize the protocols used for CT,” concluded Professor Smith. “Developing optimized protocols that balance image quality and dose and of standardizing and updating protocols needs to be simplified, and manufacturers need to get involved in this role. Currently, optimized protocols are not freely shared, and there is a huge role that manufacturers can play in advancing this.”

Various approaches have been used to optimize CT radiation doses.

For example, doses for individual patients can be minimized by refining the scan coverage, altering technical parameters, or by software techniques such as iterative reconstruction. One widely used approach to standardize radiation doses is the creation of target dose levels or diagnostic reference levels.

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Image: Research shows CT radiation doses vary widely among countries (Photo courtesy of Getty Images).

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Dedicated MRI System Scans Neonates Inside the NICU compact magnetic resonance imaging (MRI) system designed to be placed inside the neonatal intensive care unit (NICU) reduces the risks involved with transporting infants to an external facility, as well as generating major cost savings.

The Embrace Neonatal MRI System is a fully enclosed device that does not require a safety zone or shielded room, and can thus be placed inside a NICU environment. Babies undergoing scans are placed inside a temperature-controlled self-contained incubator bed, which minimizes movement, while allowing for environmental control and continuous monitoring of its vital signs. Information gained from the MRI can identify possible brain injury and in the future guide which treatments may assist in preventing disability.

Introduced by Aspect Imaging (Shoham, Israel; www.aspectimaging.com), the new system's features include a workflow that allows prep and scan in less than one hour of neonates with a head circumference up to 38 centimeters and weight between one and 4.5 kilograms; a dedicated head coil enabling diagnostic quality brain imaging; three size swaddles to reduce infant movement and allow routing of tubing and monitoring leads; a noncryogenic technology that does not require a cooling system; and PACS/HIS/RIS connectivity with DICOM compatibility. The system is contraindicated for all infants with metallic or electronically active implants.

“Operating and maintenance costs of the Embrace Neonatal MRI System are much lower than conventional superconductor MRIs due to Aspect’s magnet technology, which requires no

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just 7 kg, which allows it to be hand-carried to the POC, be it in a hospital, surgical suite, mobile clinic, or in the field. Since the fully wireless system needs no cords, cables, or power supply, it is ideal for mobile medical imaging. In addition, the Smart-C-arm also provides an integrated surgical platform with an independent articulating arm and monitor for added flexibility for any healthcare setting.

Features of the device developed by Turner Imaging Systems (Orem, UT, USA; www. turnerxray.com), include a carbon fiber frame for durability and strength; a 15x15 cm highsensitivity flat panel detector (FPD) with a complementary meta-oxide-semiconductor (CMOS) sensor that provides easy positioning in tight spaces; intuitive imaging software on a touch screen tablet; a sophisticated imaging al-

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cooling system and has low power consumption,” said Uri Rapoport, CEO and Founder of Aspect Imaging. “Our vision is to help the most vulnerable population of all – premature babies – using our technology to assist neonatologists with their clinical diagnoses, and improve neonatal care wherever it will be used.”

“The installation of the state-of-the-art, neonatal MRI system will greatly enhance the research capabilities of Brigham and Women’s Hospital, and elevate and expand neurocritical care for our littlest patients,” said Terrie Inder, MD, chair of the department of pediatric newborn medicine, which installed the first Embrace device in the USA. “Locating this technology within the NICU will reduce time and patient risk associated with transporting newborns to a traditional MRI and allow MRI access from the first hours of life through the challenging, sometimes life threatening, time within the NICU.” Image: The Embrace Neonatal MRI System inside a NICU (Photo courtesy of Aspect Imaging).

Mini C-Arm Provides Truly Portable Radiology Solution cont’d from cover

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gorithm with automatic detection of dense objects and adjustment of contrast and brightness to optimize images and improve visualization; an independent articulating arm for optimal positioning and independent tabletop use; and an optional monitor cart for clear field-of-view (FOV) positioning.

“The Smart-C will revolutionize how and where doctors use x-rays. We envision the Smart-C being particularly useful for humanitarian aid workers, including Doctors Without Borders,” said D. Clark Turner, PhD, founder and CEO of Turner Imaging Systems. “Other specialty applications will include imaging in sports medicine, especially on the field or in the locker room, in-office outpatient orthopedic surgeries, care on military battlefields, extremity injections for pain management, mobile radiology units in rural areas, emergency rooms, and much more.”

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ISSN 0898-7270 Vol.37 No.2 • Published, under license, by Globetech Media LLC Copyright © 2019. All rights reserved. Reproduction in any form is forbidden without express permission.

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New Scanner Assesses Risk of Pressure Ulcers cont’d from cover

tissue damage by measuring surface capacitance, an electrophysical marker indicative of increased fluid content within the skin and underlying tissues and a sign of impending inflammation and pressure ulcer formation, especially at the heels and sacrum. The early detection capability can lead to accurate targeted interventions, reduced ulceration severity, and early recovery, as well as decreased hospital days.

Advantages of the The Bruin Biometrics (BBI; Los Angeles, CA, USA; www.bruinbiometrics.com) point of care (POC) device include objective, evidence-based measurements; non-invasive, rapid results; clear risk assessment documentation; standardized patient assessment; and wireless syncing to a databank for rapid analytics and reporting to healthcare providers. In clinical studies, the SEM scanner has been shown to identify pressure-induced tissue damage up to 10 days before it becomes visible on the skin’s surface, and can also help with the more difficult diagnosis of pressure ulcers in patients with a darker skin tone.

“Total prevention of avoidable pressure injuries is mathematically impossible under the current standard of care; prevention success demands objective, early, anatomically specific data,” said Martin Burns, CEO of BBI. “For the first time, clinicians will have access to anatomically specific risk assessment data that can be gathered from increased risk patients in all care settings. We are optimistic of the impact these data will have on prevention strategies. Our singular objective is to reduce pressure injury incidence by helping clinicians make prevention real.”

“Anatomically specific risk information gives nurses valuable advance notice to institute additional preventive treatment tailored to a patient’s unique needs,” said Ruth Bryant, PhD, president-elect of the Association for the Advancement of Wound Care (AAWC; Mt Royal, NJ, USA). “The anatomically specific information, combined with tailored preventive actions may ultimately translate into fewer pressure sores, decreased costs, increased quality of patient care, increased patient sat-

isfaction and decreased risk for adverse events due to pressure ulcers such as in-hospital mortality, prolonged length of stay, discharge to an extended care facility rather than to the home, and infection.”

Bedsores, also known as decubitus ulcers, are lesions caused by factors such as unrelieved pressure; friction; humidity; shearing forces; temperature; age; continence and medication. They can occur in any part of the body, especially over bony or cartilaginous areas such as sacrum, elbows, knees, and ankles. Bedsores are often fatal, even under the auspices of medical care, and are one of the leading iatrogenic causes of death reported in developed countries, second only to adverse drug reactions. The primary treatment is to remove the pressure by turning the patient regularly, often as much as every two hours.

Image: A novel scanner detects detect localized tissue edema and bedsores (Photo courtesy of Bruin Biometrics).

Autonomous MRI Solution Enables More Efficient Scans cont’d from cover

senses if the image quality is below an acceptable range, prompting the operator to reacquire them. An accelerated non-cartesian four-dimensional (4D) cardiac flow sequence can thus be acquired in just minutes, allowing necessary calibrations prior to the myocardial delayed-enhancement acquisition.

The AI-driven solution breaks down barriers for wider adoption of cardiac MRI exams. Patients benefit from fewer breath holds and reduced discomfort, and also enjoy increased access to imaging, especially those suffering from arrhythmia, intolerance to long exams, and other health constraints. Technologists benefit from the reduced complexity of exams, while clinicians can simultaneously remotely monitor and guide the exams and review scans acquired with consistency and confidence, including preliminary measurements of left ventricular function.

“We are thrilled to introduce the first autonomous MRI solution that incorporates years of innovation and collaboration with world-class clinicians, technologists and researchers across major institutions,” said William Overall, founder and CTO of HeartVista. “Magnetic resonance imaging offers one of the richest diagnostic imaging techniques today and our mission is to enable fast, efficient and simple MRI exams so patients, providers, and radiologists can all benefit.”

Cardiac MRI is an imaging technology for the non-invasive assessment of the function and structure of the cardiovascular system based on the same basic principles as magnetic resonance imaging (MRI), with optimizations that use rapid imaging sequences. As a result, CMR images are currently acquired in steps. Patients breathe in and then hold their breath for each image, then recover before repeating the process for the next image.

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The P25 provides high-definition images to vastly increase diagnostic confidence. Its sophisticated features and probe configurations provide a comprehensive solution to manage all aspects of the daily clinical practice with ease and certainty.

The Raffine-i provides high image quality, exceptional workflow efficiency and effective dose control. Its wide tabletop combines excellent mobility with the highest level of safety and comfort for both the staff and patients.

The 451P features a pressurized ionization chamber, providing enhanced sensitivity to measure radiation rate and dose from X-ray and gamma sources. Its measurement surveying capabilities make it well suited for a wide range of users.

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Artificial Intelligence Powered Algorithm Enhances Digital Radiography Images n integration of deep learning technology and digital radiography (DR) helps clinicians accurately interpret medical imaging, leading the way to better diagnoses and improved patient care.

The ContextVision (Stockholm, Sweden; www.contextvision.com) Altumira software has been specially designed to meet the demanding needs of DR by providing greater contrast and resolution in parallel with intelligent noise suppression and harmonized intensity levels. The software has been designed for all DR systems, from plain X-ray to advanced angiography systems, including low-dose fluoroscopy and high-quality angiography sequences.

By using artificial intelligence (AI), optimal image quality can be achieved even with varying conditions, such as different dose exposures and different anatomies for both static and dynamic imaging. Altumira addresses significant challenges regarding durability and high image quality, including varying exposure conditions

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between patients; a wide variety of image characteristics and requirements for all types of anatomies; and varying dose and intensity levels, as well as organs and collimators in motion in dynamic sequences.

“This new product has been designed for Xray systems that can be used for both static and dynamic imaging. These combined systems are increasingly being used in healthcare and a growing segment,” said Anita Tollstadius, CEO of ContextVision. “Our customers can now meet the demanding needs of digital radiography today, by handling all types of variations within and between images and sequences for both plain and dynamic digital radiography.”

“ContextVision’s success is built on extensive technological and application knowledge paired with a broad technology platform,” said Fredrik Palm, vice president of OEM business at ContextVision. “Deep learning is a natural fit, and we’ve now incorporated it as a core technology. We are relentless in our pursuit of R&D

and product development to continuously spearhead the medical image processing and image analysis field with invaluable products.”

Deep learning is part of a broader family of AI machine learning methods based on learning data representations, as opposed to task specific algorithms. It involves artificial neural network (ANN) algorithms that use a cascade of many layers of nonlinear processing units for feature extraction and transformation, with each successive layer using the output from the previous layer as input to form a hierarchical representation.

Image: Machine learning can help improve digital x-ray images (Photo courtesy of ContextVision).

Immobilization System Aids Head and Neck Radiotherapy n innovative patient head restraining system offers unique corrective pitch capability and positioning flexibility during stereotactic radiosurgery (SRS).

The CIVCO Radiotherapy (Coralville, IA, USA; https://civcort.com) Solstice SRS Immobilization System is comprised of a carbon fiber head support, a customizable cushion, and a dedicated thermoplastic mask designed for secure and simple attachment. The combined components create a highly customizable and comfortable head and neck immobilization system, with a variable pitch capability that provides increased setup options during computerized tomography (CT) simulations, and corrective positioning flexibility during treatment setup.

The midline thermoplastic mask attachment provides increased rigidity and minimizes shrinkage, thanks to a variety of thermoplastic materials, including intensity-modulated radiation therapy (IMRT) Reinforced and ClearVision open-face variants that are compatible with the Vision RT (London, United Kingdom; www.visionrt.com) AlignRT cam-

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era system. The system can also be adapted for use with the proprietary Precise Bite positioner to aid in effective and repeatable positioning.

“The Solstice SRS Immobilization System is the only midline thermoplastic mask system on the market with variable pitch capability, increasing setup options in CT simulation and allowing positioning flexibility during treatment,” said John Steffen, director of product management at CIVCO. “We are excited that clearance in the United States and European Union opens opportunities for us to provide this unique solution to radiotherapy clinics to help improve patient outcomes.”

Reproducible positioning of the patient over multiple rounds of RT demands reliable immobilization for an accurate and consistent treatment setup. The use of low-temperature thermoplastic materials molded over the patient’s head effectively restricts movement, reducing the amount of time that it may take to receive RT and minimizing unwanted side effects such as damage to the skin, the upper digestive tract, and rampant caries due to damage to saliva glands.

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Multi-Spectral Device Images Blood Flow and Perfusion new device reveals real-time blood flow and perfusion in vascular structures and critical tissues during surgery. The RFPi (Greenville, NC, USA: http://rfpi-co.com) iCertainty platform provides non-invasive, real-time multi-spectral physiologic visualization (MSPV), a combination of low-energy lasers, high-speed imaging cameras, patented analysis techniques, and flow-calculation algorithms that together can deliver real-time visualization and quantification of blood flow and perfusion. The system does not require contrast agent injections, dyes, or radiation, in contrast to traditional modalities such as Xray, ultrasound, and magnetic resonance imaging (MRI).

The system can image blood flow and perfusion in skin and tissue to a depth of 4-5mm, with potential applications including gastrointestinal and plastic surgery, as well as lower-leg vascular procedures. By allowing surgeons to immediately visualize blood flow and perfusion, iCertainty offers the potential to reduce procedural complications or repeat surgeries, reduce hospital costs, and objectively measure and improve clinical outcomes. The company is also developing a mobile device for outpatient settings, such as wound care and diabetic clinics.

“Repeat surgery rates in iCertainty’s target indications run as high as twenty percent, a figure that masks a tremendous amount of patient discomfort, uncertainty and inconvenience, as well as financial loss for hos-

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pitals and insurers,” said Jeffery Basham, CEO of RFPi. “iCertainty offers an entirely new and advanced standard of imaging detail, speed, ease and flexibility that should benefit surgeons, hospitals and third-party payers and, most importantly, the patients they all care for.”

Image: A novel imaging platform reveals profusion and blood flow (Photo courtesy of RFPi).

Superficial Radiation System Treats Keloid Scars novel image-guided superficial radiation therapy (SRT) system offers a non-invasive, painless option for treating keloid scars.

The Sensus Healthcare (Boca Raton, FL, USA; www.sensus healthcare.com) SRT-100+ is a complete, stand-alone, x-ray radiation therapy (RT) system intended for SRT of oncological and non-oncological skin conditions, including primary malignant epithelial neoplasms of the skin and keloids. The system consists of two major separate components; a control console that was specifically designed to house the switches and indicators used by the operator to set up and execute x-ray exposures, but without treatment planning capability; and the base unit.

The base unit consists of a cabinet containing a high voltage generator, power supply components, a cooling system, and a positioning mechanism on which the SRT x-ray tube housing assembly is mounted.

The system also includes a series of applicators designed to be affixed to the x-ray port, which limit the x-ray beam spread and provide a fixed source-to-skin distance (SSD). The X-ray tube housing assembly also contains a motorized filter mechanism, which moves the appropriate beam filter into the beam path, depending on the kV setting selected.

The system produces and emits filtered, low energy (50, 70, and 100 kV) x-ray radiation, electrically generated using a conventional ceramic x-ray tube, which is confined to the specified treatment field. To mitigate the effects of the ionizing radiation on healthy cells, and to accumulate more damage in the neoplastic cells and fibrous keloid cells associated with scar tissue, the total dose is fractionated over a period of time, with remote diagnostics and operation tracking.

“Sensus is committed to constantly innovating and creating solutions that are truly life-changing for people all over the world, and we have listened closely to both doctor and patient feedback to create the sophisticated SRT-100+ to ensure patient safety and comfort,” said Joe Sardano, CEO of Sensus Healthcare. “Keloids are very common and can develop in any place where trauma occurs, especially after surgery. Both doctors and patients need an effective solution to treat keloids and keep them away once and for all.” “Keloids not only have a high recurrence rate, but they also significantly affect a person’s confidence and quality of life. As such, our team is constantly looking for better ways to treat patients who are afflicted with keloids in the most non-invasive, painless way possible,” said Kenrick Spence, MD, of Hillcrest Plastic Surgery (Orlando, FL, USA). “We look forward to treating patients with the SRT-100+ and providing an important option for the treatment and prevention of keloids.”

Keloid scars are areas of fibrous tissue that replace normal skin after injury; apart from minor lesions, every wound results in some degree of

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scarring. The scar tissue is composed of collagen, but the fiber composition is different; instead of the normal, random, basket-weave formation of the collagen fibers found in normal tissue, the collagen cross-links and forms a pronounced alignment in a single direction, which results in inferior functional quality.

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FLAT PANEL DETECTOR

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The 3D SCANNER Halcyon Kit with SNC Dosimetry v3.6 supports beam model verification of Varian Halcyon systems. Its set-up process and software have been developed to improve data accuracy.

The VIVIX-S 1717N features wireless data transmission and support for line trigger mode. It offers high spatial resolution and comes with proprietary AED function for reliable performance.

The Multix Impact is designed to create a positive patient experience. Its touch screen allows staff to stay with patients longer while a camera and Csl detector protect them from unnecessary radiation.

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Robotic Arm Optimizes Ultrasound Probe Testing new robotic cell offers an integrated solution to make the testing of ultrasound transducer probes more efficient and traceable.

The robotic cell, developed in a collaboration between Esaote (Genova, Italy; www.esaote.com) and The BioRobotics Institute of Scuola Superiore Sant’Anna (Pontedera, Italy; www.santannapisa.it), consists of a collaborative robot arm from Universal Robots (Odense, Denmark; www.universal-robots.com) and a Schunk gripper equipped with custom fingers that with the aid of a human operator, can verify correct probe positioning during testing. To increase reproducibility and repeatability during testing, the robotic cell automates the process.

Users thus have more precise data, including the most important, characterizing measurement of an ultrasound probe, the pulse echo measurement. The pulse echo measurement from each single array element, which identifies waveform, bandshape quality, and amplitude, consists in simply receiving an ultrasound pulse sent into a water tank from the probe itself and reflected from a metallic target. Probe performance parameters that can be analyzed include image quality (SNR), maximum diagnostic depth, operational frequencies, and many others.

With the human operator working alongside the robot, without the need of external technologies, the human can perform all the highly precise manipulation tasks, by visually monitoring the process and easily interacting with the robot. All the repetitive tasks, covering actions requiring a low level of know-how, are demanded to the robot, increasing the productivity of the process. The robotic cell can thus make it possible to execute precise probe positioning in the water tank, in terms of spatial resolution for all the degrees of freedom used for probe alignment during the test.

“The robotic cell has reached two goals; the first is to automate the

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procedure for the operation of the tests; the second is to keep in the foreground the role of man. Esaote operators will interact with the robot, supporting it during the tests,” said Marco Controzzi, of The BioRobotics Institute. “This line of research reflects the mission of ‘Human-Robot-Interaction’, the laboratory of collaborative robotics of The BioRobotics Institute. We imagine a synergy between men and robots, combining the advantages of manual production with precision and repeatability of automation.”

An ultrasound transducer typically consists of 128-512 piezoelectric elements that are arranged in linear or curvilinear arrays, with each element equal to or less than a ½ wavelength wide. The purpose of the transducer is to convert electrical energy into mechanical sonic energy and back again, based on the piezoelectric effect. A standard ultrasound transducer is comprised of a piezoelectric ceramic, a hard rubber backing substrate, several (usually one to four) acoustic matching layers, and a silicon rubber lens.

Image: A robotic arm with custom fingers helps test ultrasound probes (Photo courtesy of Esaote).

US-CNB Biopsy Improves Breast Cancer Staging new study shows that ultrasound-guided core-needle biopsy (US-CNB) bests ultrasound-guided fine-needle aspiration (USFNA) when diagnosing axillary lymph node metastasis.

Researchers at the National University of Ireland Galway (NUI Galway; Ireland; www.nuigalway.ie) and Cork University Hospital (CUH; Ireland; www.cuh.hse.ie) conducted a meta-analysis of all published studies comparing the diagnostic accuracy of axillary lymph node ultrasound-guided biopsy. Studies were included if raw data were available on the diagnostic performance of both US FNA and US CNB, and compared with final histology results. In all, from a total of 142 studies, six remained after review, with all six showing some evidence of bias,

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including ack of initial randomization.

The results, based on the data of 1,353 patients from the six studies that met inclusion criteria and were included in the final analysis, revealed that US CNB was superior to US FNA in diagnosing axillary nodal metastases, with a sensitivity of 88% versus 74%, respectively; both US CNB and US FNA demonstrated a specificity of 100%. Reported complication rates were significantly higher for US CNB (7.1%) compared with US FNA (1.3%). Conversely, the requirement for repeat diagnostic procedures was significantly greater for US FNA (4%), compared to 0.5% for US CNB. The study was published in the September 2018 issue of BJS. HospiMedica International April-May/2019

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Medical Imaging

CT-Based Analysis Platform Detects Brain Bleeds

Real-Time MRI Reveals How Beatboxers Produce Sound

new medical imaging app uses artificial intelligence (AI) to identify intracranial hemorrhage (ICH) from computed tomography (CT) scans.

The MaxQ AI (Tel Aviv, Israel; www.maxq.ai) Accipio Ix platform is an image-based decision support tool that uses AI technology to quickly assess patients suspected of head trauma or stroke so as to rule out ICH. The software app uses non-contrast CT images and processes them in the cloud, using proprietary algorithms that note changes and highlight suspicious, potential areas of bleeding. The enhanced images are sent back to the doctor’s workstation, together with the original CT scan.

The algorithms were developed using deep learning (DL) and billions of images from millions of cases acquired through collaborations with hospitals such as Hadassah Medical Center (Jerusalem, Israel) and Massachusetts General Hospital (Boston, MA, USA). By analyzing multiple series of images, the Accipio Ix algorithm learned what an ICH looks like and set benchmarks for baseline readings. Using the platform, emergency healthcare providers can prioritize clinical assessment and care of patients with hemorrhagic stroke or intracranial trauma within three to five minutes.

MaxQ has announced partnerships with IBM (Armonk, NY, USA; www.ibm.com) Watson and Samsung NeuroLogica (Danvers, MA, USA; www.samsungneurologica.com) to integrate its products into their radiology software and hardware platforms. Samsung NeuroLogica plans to use the software in mobile stroke units equipped with its CereTom CT scanner to allow staff to differentiate between ischemic strokes and hemorrhagic strokes in the field, and allow them to give clot busters while en-route to the hospital. The company also signed a five-year distribution deal with GE Healthcare (GE, Little Chalfont, United Kingdom; www.gehealthcare.com) in November 2017.

new study shows how real-time magnetic resonance imaging (MRI) can be used to understand how beatboxers produce percussion sounds. Researchers at the University of Southern California (USC; Los Angeles, USA; www.usc.edu) used real-time MRI data to observe the vocal tracts of beatboxers just before they make a sound. The MRI data provides a dynamic view of the entire midsagittal vocal tract at a frame rate high enough to observe the movement and coordination of critical articulators. The study evaluated beatboxers of different ages and genders, and with different native languages, in order to characterize different styles, using video signal processing to demystify the vocal mechanics.

One of the main challenges for the researchers was to develop the algorithms they used to quantify the movement of the beatboxer’s vocal tract. To do so, a linguist labeled all the various parts of the body involved in sound production, such as the tongue and the roof of the mouth. The algorithm then tracked the images of these various parts as they moved during the production of sound.The study was presented at the Acoustical Society of America’s 176th annual meeting, held during November 2018 in Victoria (Canada)

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New WBRT Technique Reduces Neurocognitive Decline Risk dverse cognition effects of whole- brain radiotherapy (WBRT) can be significantly mitigated by using a hippocampal sparing technique and a neuroprotective agent, claims a new study.

Researchers at Northwestern Medicine Cancer Center (Warrenville, IL, USA; www.nm.org) conducted a study in 518 adult patients with brain metastases who were stratified by analysis of prognostic factors and by whether or not they had previously undergone radiosurgery or surgical resection. The patients were randomized to a combination of memantine (a low-affinity glutamatergic antagonist) and WBRT at a dose of 30 Gy in 10 fractions, or to memantine plus WBRT and hippocampal avoidance, again at a dose of 30 Gy in 10 fractions.

The results revealed that at six months, cognitive function failure rates were 59.5% in the hippocampal avoidance arm, compared 68.2% in the control arm, a 24% reduction. Cognitive function failure curves began to separate at three months, maintained through the follow-up period. Following adjustment for treatment factors and age, the additional use of hippocampal avoidance techniques led to a 26% relative risk reduction in cognitive failure compared with WBRT plus memantine, in all age groups. The study was presented at the American Society for Radiation Oncology (ASTRO) annual conference, held during October 2018 in San Antonio (TX, USA).

“Quality of life for patients with brain metastases can be largely driven by their cognitive function, and we’ve come to understand that WBRT can significantly impact that cognitive function outcome as well as the quality of life associated with it,” said lead author Vinai Gondi, MD. The hippocampus (named after its resemblance to the seahorse) is a major component of the brains of humans and other vertebrates. The hippocampus belongs to the limbic system and plays important roles in the consolidation of information from short-term, long-term, and spatial memory. It is located under the cerebral cortex, and contains two main interlocking parts: the hippocampus proper (also called Ammon’s horn) and the dentate gyrus.

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PRODUCT NEWS PORTABLE DEFIBRILLATOR

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ECG DEVICE

INFANT RESUSCITATOR

Primedic

Aspel

Philips Healthcare

The HeartSave AS delivers an electric shock preceded by an audible warning if it detects life-threatening fibrillation. Its voice feature prompts and guides first aid personnel stepby-step through the rescue procedure.

The AsCARD Green v.06.101 is a 1-, 3-, 6- and 12channel ECG for exams of adult and pediatric patients. It is equipped with a thermal printer, high-resolution LCD display, touch panel and easy navigation.

The Augmented Infant Resuscitator is an add-on device for conventional neonatal BVM resuscitators. It measures ventilation flow and pressure, and provides intuitive visual feedback on common ventilation errors.

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Stimulation Therapy Restores Digestive Motility cont’d from cover

electrical stimulation, contractions are generated in a pattern imitating natural esophageal swallowing motions, promoting motility throughout the gastrointestinal (GI) tract, preventing reflux, improving digestion, and restoring gastric emptying.

The system, developed by E-Motion Medical (Tel Aviv, Israel; www.emotionmed.com) is comprised of the E-Motion Tube, a disposable oro/nasogastric feeding tube fitted with stainless steel electrodes along its length that delivers the stimulation to the esophageal mucosa, and the E-motion EPG 1000, a durable, touchscreen operated, bedside control unit that generates the electric stimulation pattern and sends it via the feeding tube to various locations along the esophagus. Asynchronous esophageal motion is thus induced, reducing reflux and increasing GI motility, enabling safer and better feeding.

“There is currently no adequate solution for the widespread problem of acute digestive dysmotility,” said Amichay Gross, co-founder and CEO of E-Motion Medical. “Our technology provides a new and first of its kind therapy to promote the physical function of the digestive sys-

tem, and consequently improve outcomes and lower financial burden on the healthcare system.”

Acute GID manifests as reduction in, or lack of, motility in the digestive system, and is common in neurological, trauma, surgical, geriatric and also severe diabetic patients. In addition, gut motility has been shown to correlate to other physical functions in the body, including that of the diaphragm and the lungs, as well as other systems required for patient recovery.

Image: The E-Motion EPG 1000, and Tube (Photo courtesy of E-Motion Medical).

Noninvasive Neurostimulator Helps Prevent Cluster Headaches novel non-invasive vagus nerve stimulation (nVNS) device excites the nerve’s afferent fibers, leading to headache pain reduction. The electroCore (Basking Ridge, NJ, USA; www. electrocore.com) gammaCore is hand-held adjunctive therapy device indicated for the prevention of cluster headaches and for the treatment of the acute pain associated with episodic cluster headache and migraine.

The portable device provides a mild electrical stimulation to the vagus nerve, without the potential side effects associated with commonly prescribed drugs. The self-administered treatment consists of three consecutive two-minute stimulations twice a day, with the first treatment applied within one hour of waking up and the second seven to 10 hours later; the device does not prevent migraines.

In two clinical studies, nVNS patients had 3.9 fewer cluster attacks per week than those who received standard of care (SOC). In addition, 40% of those patients who received gammaCore in addition to SOC experienced a 50% or greater reduction in weekly cluster attacks, compared to 8.3% of patients who received SOC alone. Also, a 57% decrease in the frequency of abortive medication use among those who received gammaCore plus SOC care was demonstrated,

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while those patients who received SOC alone did not experience a substantial reduction.

“Clearance of gammaCore for adjunctive use for the preventive treatment of cluster headache has the potential to help the approximately 350,000 Americans impacted by this debilitating condition, often referred to as a suicide headache,” said Frank Amato, CEO of electroCore.

“We are pleased that cluster headache patients now have a FDA-cleared option, and one that is both safe and effective, especially given the difficulty in treating cluster headache and the limitations of current treatments.”

Cluster headache is a rare but extremely painful disorder characterized by recurring unilateral attacks. The condition is the least common type of headache disorder, occurring in 1-2 out of 1,000 individuals, affecting predominantly males, heavy smokers and those with a family history. Symptoms typically manifest by age 30. Frequently nicknamed “suicide headache” due to the severity of pain associated with their occurrence, cluster headache bouts occur rapidly and with variable frequency, but often at the same time each year or day and are often more frequent at night.

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Hemodynamic Monitor Continuously Measures Cardiac Output novel device intended for high-risk surgical and critically ill patients’ tracks oxygen delivery status in order to maintain optimal fluid status in a patient’s circulation.

The Retia Medical (Valhalla, NY, USA; www.retiamedical.com) Argos Cardiac Output (CO) hemodynamic monitor uses multibeat analysis (MBA) algorithms and signal processing to derive a blood pressure (BP) waveform and a parametric model of blood circulation. An intuitive user-friendly interface seamlessly integrates with all intensive care unit (ICU) and operating room (OR) vital signs monitors and common electronic medical record (EMR) systems. A single cable connection is all that is needed to acquire a BP signal from any vital signs monitor, facilitating set up and eliminating the need for user training.

The MBA algorithm constructs a cardiac contraction signal based on an impulse train, in which each impulse is positioned at the starting point of an arterial blood pressure pulse upstroke, which is then scaled by the subsequent pressure pulse. The MBA algorithm has an overall relative CO error of 15% after a single calibration. The Argos system also takes into calculation the confounding effects of wave reflection, especially due to resistance mismatch high-resistance arteries, which can cause significant inaccuracies.

“A key challenge in realizing the potential clinical benefits of CO monitoring is that many monitors fail to track changes accurately when fluid and vasoactive drug therapy are administered,” said Marc Zemel, cofounder and CEO of Retia Medical.

“We designed Retia’s proprietary MBA algorithm to overcome the limitations of current CO monitoring technologies in order to realize the potentially life-saving benefits that acINTERACTIVE curate and effective hemodynamic DIGITAL EDITION management can provide to patients.”

Cardiac output is a term used in cardiac physiology that describes the volume of blood being pumped by the heart, in particular by the left or right ventricle, per unit time. It is the product of the heart rate (HR), and stroke volume (SV), i.e., the volume of blood pumped from the ventricle per beat, expressed in L/min.

Because CO is related to the quantity of blood delivered to the body, it is an important indicator of how efficiently the heart can meet the body’s demands for perfusion.

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HospiMedica International April-May/2019

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PRODUCT NEWS VACUUM PUMP

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NEONATE COOLER

PATIENT MONITOR

MedGyn

Drager Medical

Nihon Kohden

The HVP-100 safely assists medical personnel during vaginal deliveries. The reusable pump is manually operated to produce the required vacuum and maintain accurate vacuum pressure.

The MiraCradle whole body device is for neonates or newborns suffering from Hypoxic Ischemic Encephalopathy due to birth asphyxia.

It can be used as a standalone solution or in combination with radiant warmer.

The Life Scope G5 is designed with a new platform for two models and the option to add up to two additional displays. It reduces false alarms, workload and the time for diagnoses, and can be customized by clinicians.

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Wireless Device Aids Recovery of Breast Cancer Patients new sensing device can provide early warning of the potential failure of breast reconstruction surgery, making it easier to take effective remedial action.

Developed by researchers at Imperial College London (Imperial; United Kingdom; www3.imperial.ac.uk), Covidien (Dublin, Ireland; www.covidien.com) and other institutions participating in the Smart Sensing for Surgery project, the wireless ‘bio-patch’ incorporates hermetically sealed sensors and an electronics board – measuring just 1.8 x 1.1cm – integrated with fully biocompatible materials. The wireless device harnesses nearinfrared spectroscopy (NIRS) to safely capture and transmit encrypted data, ensuring patient security and privacy.

In a recent clinical study, a group of patients wore the bio-patch for 48 hours after undergoing breast reconstruction surgery. The device successfully performed continuous

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monitoring of oxygen saturation levels in transferred tissue, a key indicator of whether there is a potential risk of reconstruction failure. The device is currently being adapted to help monitor other medical conditions, such as dementia and chronic obstructive pulmonary disease (COPD).

“Poor blood supply or failure of breast reconstruction surgery can have a major impact on a breast cancer patient’s recovery, prognosis and mental wellbeing,” said Professor Guang-Zhong Yang, PhD, of ICL, leader of the Smart Sensing for Surgery project. “Clinical signs of failure often occur late and patients may be returned to the operating room on clinical suspicion. Our new bio-patch tackles this problem by providing objective data as an early warning system for medical staff, enabling earlier and simpler interventions, as well as giving patients increased peace of mind.”

Breast reconstruction involves using autolo-

gous tissue or prosthetic material to construct a natural-looking breast; this often includes reformation of a natural-looking areola and nipple.

Generally, the aesthetic appearance is acceptable, but the reconstructed area is often completely numb, which results in loss of sexual function as well as the ability to perceive pain.

Image: A biocompatible sensor monitors breast reconstruction surgery outcomes (Photo courtesy of EPSRC).

Remote Solution Passively Monitors Activities of Senior Patients wearable-assisted, gesture detection remote patient monitoring (RPM) platform caters for the needs of the growing elderly population. The Somatix (Raanana, Israel; www.somatix.com) SafeBeing RPM system passively monitors elderly individuals’ activities of daily living (ADL), such as sleeping, drinking, walking, and medication intake, as well as real time alerting of falling and wandering. The system is powered by a proprietary real-time gesture detection platform that leverages standard existing sensors already present in commercial off-the-shelf smartwatches, smartbands, and Internet of Things (IoT) connected devices (such as heart rate sensors, gyroscopes, accelerometers, GPS, and others), to collect the data needed for analysis.

Once uploaded to the cloud, the gesture data is structured according to range of parameters – i.e. what, when, where, why, and at what frequency a specific action is taken – and is subjected to continuously adaptive machine learning, enabling precision recognition of significant behavior patterns. It additionally employs adaptive machine learning and predictive analytics to passively monitor massive volumes of gesture data, for precision recognition of a range of physiological and emotional in-

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dicators. The system operates in a continuous loop, measuring behavioral modifications.

Using these tools, SafeBeing can detect variations in hand gestures that could be a cause for concern, and can trigger alerts to caregivers or family members. The platform can also be used to issue variable combinations of personalized cognitive behavior therapy (CBT) incentives, ultimately helping to increase adherence with treatment objectives, enhance wellbeing, and improve people’s lives. Since the system is based on gestures, rather than specialized hardware installation in the user’s environment, the passive monitoring provides elderly people full independence and the freedom to go about their daily activities uninterrupted.

“The global population of people aged 65 and older is expected to nearly double by 2050, driving a surge in demand for digital health innovation,” said Eran Ofir, CEO of Somatix. “SafeBeing is designed to facilitate ‘aging in place’ and provide both users and caregivers with peace of mind. It is easy to implement, and is fully aligned with the remote patient monitoring regulatory landscape, such as reimbursement policies.”

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Critical Care

Novel Catheter Facilitates Vascular Access Procedures n inside-out arteriovenous (AV) access system reliably, safely, and repeatedly achieves central venous access in hemodialysis patients awaiting maturation of a permanent AV fistula.

The Bluegrass Vascular (San Antonio, TX, USA; www.bluegrass vascular.com) Surfacer System is inserted through the femoral vein, and then threaded through the patient’s venous system to an exit point in the right internal jugular vein. A central venous catheter (CVC) can then be reliably placed into the optimal location, the right atrium, using the Surfacer System as a guide. The so-called “inside-out” approach thus helps achieve access to the occluded right internal jugular vein, while preserving the viability of potential secondary central veins.

A new retrospective study of 32 patients conducted by researchers at the Medical University of Vienna (Austria; www.meduniwien.ac.at) found that the Surfacer System had an impressive 97% success rate in all patients. There were zero device-related complications reported, including bleeding, hematoma, and catheter-related infection, and all patients displayed similar catheter function at three months. The study was presented as a poster session at the American Society of Nephrology (ASN) annual meeting, held during October 2018 in San Diego (CA, USA).

“The clinical application of the Surfacer System, as shown in this study, proves to be extremely positive,” said lead author Roman Reindel-Schwaighofer, MD, a nephrology and dialysis fellow at the Medical University of Vienna. “The Surfacer System provides a safe and effective solution that both preserves and restores vascular access for patients requiring hemodialysis who otherwise have very limited options.”

“The idea for the Surfacer was born from seeing many patients with obstructed central venous systems who needed life-saving vascular access therapies, whether that be pacemakers or defibrillators or dialysis

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access,” said John Gurley, MD, founder of Bluegrass Vascular Technologies and inventor of the Surfacer. “Our unique system offers physicians an innovative yet simple solution. If the veins are obstructed and you can’t put a needle in from the outside, you can now go inside the body and direct the needle out.”

While an AV fistula remains the preferred access option for patients on hemodialysis therapy, these often can take four months or longer to mature, and a CVC is often required during this time period; but more than 40% of such patients develop a venous obstruction. Many patients, in fact, prefer a CVC over an AV fistula, for reasons that include inadequate preparation for dialysis, avoidance of surgery, or fear of needles (since the connection to the dialysis machine via a catheter does not require needles).

Image: The Bluegrass Vascular Surfacer System (Photo courtesy of Bluegrass Vascular).

Public Automated External Defibrillators Improve Cardiac Arrest Outcomes utomated external defibrillators (AEDs) that are publicly accessible can improve survival following out-of-hospital cardiac arrest (OHCA), according to a new study.

Researchers at Otsuma Women’s University (Tokyo, Japan; www. otsuma.ac.jp), Osaka Municipal Fire Department (Osaka, Japan; www. city.osaka.lg.jp/contents/wdu020/shobo/english), Kyoto University (Japan; www.kyoto-u.ac.jp), and other institutions conducted a study that reviewed AED applications, prehospital characteristics, and onemonth outcomes following OHCA in Osaka Prefecture from 2011 to 2012. The proportion of AED pads that were applied to the patients’ chests by the public and one-month outcomes were analyzed according to the location of OHCA. The results showed that public-access AED pads were applied to 3.5% of OHCA patients during the study period.

Cardiac arrests that occurred in a public place and received bystander-initiated cardiopulmonary resuscitation (CPR) were associated with significantly higher application of public-access AED pads, with 29.6% receiving public-access defibrillation. One-month survival with a favorable neurological outcome was significantly higher among patients who had an AED applied (19.4%), compared to those who did not (3%). The study was presented at the American Heart Association (AHA) resuscitation science symposium, held during November 2018 in Chicago (IL, USA).

“The application of public-access AEDs leads to favorable outcomes after an OHCA, but utilization of available equipment remains insufficient, and varies considerably according to the location of the OHCA event,” concluded lead author and study presenter Takefumi Kishimori, MD, of Kyoto University, and colleagues. An AED is a portable electronic device that automatically diagnoses life-threatening cardiac arrhythmias, such as pulseless ventricular tachycardia (VT), and is able to treat them through defibrillation, allowing the heart to reestablish an effective rhythm. AEDs are designed to be simple to use for the layperson, using basic audio and visual commands to guide defibrillation. The use of AEDs is taught in many first aid, certified first responder, and cardiopulmonary resuscitation (CPR) classes.

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PRODUCT NEWS CPET SYSTEM

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FETAL/MATERNAL MONITOR

ECG DEVICE

Schiller

Arjo Huntleigh

Teknova Medical Systems

The CARDIOVIT CS-200 Office ErgoSpiro performs cardiopulmonary function tests (CPET) according to the latest ATS/ERS guidelines. The tests, combined with a 12-lead ECG, make it suitable for a range of patients.

The Sonicaid Team 3 Series features an easy-to-use, intuitive icon-driven touch screen that displays the fetal heart rate. The monitor auto-scales depending on single, twin or triplet monitoring for optimum visibility.

The TE60 six-channel device features powerful analysis and diagnostic software for automatic measurement and interpretation. It offers three work modes and a rechargeable battery with two hours of working time.

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Dual Lumen Catheter Advances Extracorporeal Oxygenation n innovative single use dual lumen catheter provides both venous drainage and reinfusion of blood via the jugular vein. The MC3 Cardiopulmonary (Dexter, MI, USA; mc3corp.com) Crescent Jugular dual lumen catheter is indicated for use in patients suffering from acute respiratory failure and who require veno-venous extracorporeal membrane oxygenation (ECMO) where other available treatment options have failed, and the patients continued clinical deterioration is expected, or when the risk of death is imminent. The Crescent Jugular catheter is threaded through the jugular vein and into the inferior vena cava (IVC); once connected to an ECMO system, it is used to remove carbon dioxide (CO2) and reinfuse oxygenated blood.

Catheter features include a unique crescent-shaped dual lumen design that optimizes pressure flow performance and minimizes recirculation; a tapered and extended tip that enables smooth insertion and ensures the catheter remains within the inferior vena cava; graduated radiopaque markers that aid in precise positioning and tip orientation during placement; and an integrated gold suture collar that secures the highly durable placement procedure and reduces the risk of inadvertent cutting through of the catheter.

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Image: The Crescent Jugular dual lumen catheter (Photo courtesy of MC3 Cardiopulmonary)

“Until recently, mechanical ventilation with intubation was the last line of defense for millions of patients around the world each year. The introduction of our Crescent catheter means new options for surgeons and their patients,” said Scott Merz, CEO of MC3 Cardiopulmonary.

“Due to the advancements in technology available in Crescent, we can now consider cannulating the sickest of these patients instead of intubating them. Our shared vision with the clinical community is to take standardized ECMO care from possibility to reality.”

ECMO is a form of veno-venous extracorporeal life support (VV ECLS), an emerging therapy designed to provide a higher level of care by infusing oxygen directly into the blood using an oxygenator, which acts as an artificial external lung. A tapered cannula provides omni-directional flow, optimizing gas exchange and reducing stress on the right side of the heart.

Osteoporosis Impact on Fragility Fractures Being Ignored new survey reveals that 55% of women over 60 believe that fragility fractures in older age are due to an unlucky fall or accident, rather than the result of underlying osteoporosis.

The survey, conducted by UCB (Brussels, Belgium; www.ucb.com) and Harris Interactive (Rochester, NY, USA; www.harris-interactive. com), was conducted in August-September 2018 as part of an initiative to investigate awareness, attitudes, and perceived risk of osteoporosis and fragility fractures in ten major industrialized countries: Belgium, Denmark, France, Germany, Italy, Japan, Spain, Sweden, the United Kingdom, and the United States. For the survey, 4,504 women aged 60 years and over were interviewed online about osteoporosis and fragility fractures.

The results revealed that despite women aged 60 and older being most at risk of osteoporosis and fragility fractures, 61% of the women surveyed had little or no knowledge of osteoporosis. Furthermore, 69% believe their fragile bones are an inevitable part of getting older, and 70% thought it inevitable that their risk of fragility fracture will increase.

Almost one in five (17%) commented that they felt there is very little that can be done to avoid osteoporosis, and 37% claimed their health-

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care professional had never spoken to them about these issues.

“Worldwide, fragility fractures affect one in three women aged 50 and above. Yet the survey shows those most likely to experience a fragility fracture are unaware of the condition and the significant impact it can have on their independence and quality of life,” said Pascale Richetta, MD, executive vice president of UCB. “From the survey its plain to see that today’s over 60’s maintain a great passion for life and aspirations beyond those of their parents’ generation, so questions must be asked as to why a condition that today causes more than 8.9 million fragility fractures annually and is a major obstacle to healthy ageing, is being overlooked.”

“People are living longer, and expecting more out of life, yet the dangers that accompany this are mute,” commented Philippe Halbout, MD, CEO of the International Osteoporosis Foundation (Nyon, Switzerland; www.iofbonehealth.org). “The physical and psychological impact of osteoporosis and fragility fractures is huge, and if they are not treated with the same urgency as other life-threatening diseases, their burden could cripple healthcare systems, society, families and individuals around the world.”

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Critical Care

Stimulating Cervical Neurons Sustains Post-Trauma Breathing

Fluorescent Detection Technology Advances Nephrology Care

new study suggests that stimulation of a group of dormant neurons located in the cervical area could help restore breathing following traumatic spinal cord injury (SCI). Researchers at the University of Toronto (UT; Canada; www.utoronto.ca), St. Michael’s Hospital (Toronto, Canada; www.stmichaelshospital.com), and the Krembil Research Institute (Toronto, Canada; www.uhn.ca), using a combination of pharmacogenetics and physiology assays in different models of SCI, found that mid-cervical excitatory interneurons – which form synapses on the phrenic motor neurons that control the main inspiratory muscle – can modulate phrenic motor output and diaphragmatic function.

Although these interneurons are not necessary for breathing under normal conditions, their stimulation in non-injured animals enhances inspiratory amplitude. But in a murine model, the researchers found that the same cells where crucial for promoting respiratory recovery after traumatic SCI, and that their stimulation restores respiratory motor function.

The researchers suggest that targeting this latent cell subpopulation could provide a strategy to restore breathing after central nervous system (CNS) trauma. The study was published on October 10, 2018, in Nature.

“The big takeaway here is the identification of this novel neural circuit. We found is if we activate this population of neurons using pharmacogenetics, we can rescue breathing,” said senior author professor Michael Fehlings, MD, PhD, of the UT department of surgery.

Respiratory dysfunction is a major cause of morbidity and mortality during and following SCI, often necessitating a tracheostomy or longterm use of an assistive ventilation device. The trauma causes impairment of respiratory muscles, reduced vital capacity, ineffective cough, reduction in lung and chest wall compliance, and distortion of the respiratory system. Severely affected individuals may require assisted ventilation, which can also cause problems with speech production.

new noninvasive optical device measures glomerular filtration rate (GFR) in patients with normal or impaired renal function.

The MediBeacon (St. Louis, MO, USA; www.medibeacon.com) Transdermal GFR Measurement System (TGFR) is designed to provide clinicians continuous real-time measurements of GFR at the point of care, with no need for blood sampling or urine collection. The renal function system is comprised of MB-102, a fluorescent tracer agent, light emitting diodes (LEDs) that provide excitation of MB-102, a photodiode optical skin sensor that collects the emission light, and a system monitor.

The returning fluorescent light emission is measured at the sternum; after amplification and digitization, the data sets are stored in the internal memory of the device, which is later transferred to a PC via a USB connection; a basic PC software package is provided with the device.

According to MediBeacon, GFR can be measured for a range of kidney functions, from normal to stage 4 chronic kidney disease (CKD). The system, which is currently in human trials, has not been approved for human use by any regulatory agency.

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Home Hemodialysis Improves Dialysis Patient Survival new study reveals that more frequent home hemodialysis (HHD) provides significant improvements in first-year survival in renal dialysis patients across all age ranges.

The study, conducted by researchers at NxStage Medical (Lawrence, MA, USA; www.nxstage.com), analyzed United States Renal Data System (USRDS) data for 557,139 incident dialysis patients who were prescribed more frequent HHD with the NxStage System One, or conventional in-center hemodialysis (IHD) therapy, shortly after dialysis initiation. The researchers estimated hazard ratios of death for HHD versus IHD, with adjustment for age, race, sex, primary cause of end-stage renal disease, comorbid conditions, vascular access type, body mass index (BMI), estimated glomerular filtration rate (eGFR), and hematocrit.

The results revealed that HHD patients were younger, more likely white, more likely male, less likely enrolled in Medicaid, and less likely to have heart failure (HF). Patients who initiated more frequent HHD showed improved survival, with a 23% lower risk of death versus IHD overall. The most striking results were found in patients in the 20-44 years age group, who experienced a 44% lower risk of death. The study was presented at the American Society of Nephrology (ASN) Kidney Week Conference, held during October 2018 in San Diego (CA, USA).

“Less than one percent of new dialysis patients each year perform home hemodialysis,” said lead author and study presenter Eric Weinhandl, PhD, clinical epidemiologist and biostatistician at NxStage.

The NxStage System One is designed to deliver hemodialysis, hemofiltration, and/or ultrafiltration therapies to patients with renal failure or fluid overload. System features include a highly automated design with a drop-in cartridge to facilitate operation; high-quality premixed treatment fluids to enable fluid purity without relying on local water treatment; and wide operating ranges allow clini

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MULTI-DISCIPLINARY TABLE

ANGIOGRAPHY SYSTEM

Derungs Licht

Trilux

Canon

The TRIANGO 100 features an intuitive touch panel on the luminaire suspension that ensures best usability and easy cleaning. Its unique arm system ensures easy operation with high positioning accuracy.

The Zentrum i3 is precise and predictable while being easy to operate and configure. It has a 272 kg/600 lb capacity and 454 kg/1,000 lb lift capacity, and warns users before a tipping event or a collision can occur.

The Alphenix 4D CT combines Alphenix Sky + C-arm and Hybrid Catheterization Tilt/Cradle Table for interventional procedures. It allows clinicians to efficiently plan, treat and verify in a single clinical setting.

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Artery Relocation Reduces Stroke Risk in Atherosclerosis Patients new surgical technique can significantly decrease mortality and stroke recurrence in patients with severe atherosclerosis of brain arteries, according to a new study.

Researchers at Cedars-Sinai Medical Center (CSMC; Los Angeles, CA, USA; www.cedars-sinai.edu) conducted a phase 2a clinical trial of a new surgical technique called encephaloduroarteriosynangiosis (EDAS), which involves re-routing arteries from the scalp and the membranes covering the brain and relocating them near cerebral areas at risk of stroke. Over time, angiogenesis creates fresh pathways for blood and oxygen to reach the brain. The study involved 52 patients with intracranial atherosclerotic disease (ICAD) with symptoms of either a recent stroke or transient ischemic attack (TIA). In addition to EDAS, the patients underwent intensive medical management.

The results revealed that after one year, 9.6% of the patients treated with EDAS experienced another ischemic stroke or died, compared with 21.2% of patients in a matched control group who received only intensive medical management involving diet and lifestyle changes and medications that included blood thinners, antihypertensives, and statins. Two EDAS patients required additional surgical interventions, but there were no intracranial hemorrhages or other serious adverse events. The study was presented at the World Stroke Congress, held during October 2018 in Montreal (Canada).

ICAD of the major arteries (intracranial internal carotid artery, middle cerebral artery, vertebral artery, and basilar artery) is the most common proximate mechanism of ischemic stroke worldwide, causes 3050% of strokes in Asians and 8-10% of strokes in Caucasians. Little is

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known about measures for primary prevention of the disease; in terms of secondary prevention of stroke due to ICAD, aspirin continues to be the preferred antiplatelet agent, along with clopidogrel. Aggressive risk factor management, either alone and in combination with dual antiplatelets, has been shown to be the most effective treatment.

Image: EDAS surgery reroutes scalp arteries to provide new pathways for brain circulation (white arrows) (Photo courtesy of Cedars-Sinai).

Breastfeeding Protects against Antibiotic-Resistant Bacteria new study finds that babies breastfed for at least six months have less antibiotic-resistant bacteria in their microbiota than infants breastfed for a shorter time.

Researchers at the University of Helsinki (UH; Finland; www.helsinki.fi) and the University of Turku (UTU; Finland; www.utu.fi) conducted a study that analyzed breast milk and fecal matter of 16 mother-infant pairs, focusing on the number of potential antibiotic resistance genes (ARGs). To do so, they performed metagenomic DNA sequencing of the breast milk, as well as that of infant and maternal gut microbiomes. They found that fecal ARG and mobile genetic element (MGE) profiles of the infants were more similar to those of their own mothers than to those of unrelated mothers.

Three major findings emerged. First, infantsâ&#x20AC;&#x2122; breastfed for at least six months had a smaller number of resistant bacteria in their gut than babiesâ&#x20AC;&#x2122; breastfed for a shorter period, or not at all. Second, antibiotic treat-

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ment of mothers during delivery increased the amount of antibiotic-resistant bacteria in the infant gut. Third, while breast milk also contains antibiotic resistant bacteria, the mother is likely to pass these bacteria on to the child through the milk. The study was published on September 24, 2018, in Nature Communications.

The World Health Organization (WHO) recommends breastfeeding exclusively for the first six months of life. Even after the introduction of foods at six months of age, continued breastfeeding is recommended until at least one to two years of age. In reality, only 38% of infants are only breastfed during their first six months of life on a global level, while in the United States, only about 13% breastfeed until the age of six months. Short-term benefits for the mother include less blood loss, better uterus shrinkage, weight loss, and reduced postpartum depression.

Long-term benefits include decreased risk for breast cancer, cardiovascular disease (CVD), and rheumatoid arthritis.

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Augmented Reality System Aids Laparoscopic Surgery n augmented surgical navigation system enables surgeons to annotate safety zones and guide surgical tools during minimally invasive procedures. The Mariner Endosurgery (Hamilton, Canada; http://marinerendosurgery.com) LaparoGuard system is designed to annotate areas of risk during surgical procedures, and then display three-dimensional (3D) renderings of surgeon-defined safety zones as a heads-up, real-time image overlay, providing surgeons with additional spatial awareness. The data from the system is integrated into any operating room (OR) conventional visualization equipment. LaparoGuard also provides continuous tracking of multiple tools throughout a procedure for real-time location updates within the abdominal cavity.

Features include a mix of audio-visual augmented reality (AR) on both primary and secondary surgical monitors, without the use of a conventional AR headset; intuitive real-time feedback systems that add information to the surgical team, without distractions; integration into existing clinical workflows and conventional laparoscopic tower equipment.

“LaparoGuard empowers surgeons to have the latest in advanced visualization, augmented reality and spatial awareness tools for minimally invasive procedures,” said Mitch Wilson, president of Mariner Endosurgery. “Upcoming pipeline of surgical visualization and advanced laparoscopic instrumentation will further support LaparoGuard and our company thesis of putting the right innovation, at the right time, in surgeons’ hands.”

AR is a term for a live direct or indirect view of a physical, real-world environment whose elements are augmented by computer-generated sensory input. It is related to a general concept called mediated reality, in which a view of reality is modified – possibly even diminished rather than augmented – by a computer. As a result, the technology can enhance the perception of reality.

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Image: LaparoGuard Procedural Kit by the Mariner Endosurgery.

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PRODUCT NEWS SURGICAL TABLE

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PATIENT POSITIONER

CAMERA SYSTEM

BenQ Medical Technology

Allen Medical

EIZO Display Technologies

The Dr. MAX 7000S Series features a hydraulic drive that provides multi-purpose functions. It enables flexibility for patient positioning, while its tabletop sliding function minimizes set-up time and patient discomfort.

The Allen Hug-U-Vac Steep Trend Positioner safely holds patients in the Trendelenburg position. It conforms to the patient’s supine anatomy, and its quick-release straps attach it to standard operating table rails.

The CuratOR SC430-PTR features a fully integrated triaxial mount for capturing surgical proceedings. It offers 4K ultra high-definition at 60p and 30x optical zoom for clear, close-up images.

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Cut Guide System Facilitates Controlled Lapidus Correction ew instrumentation allows surgeons to attain accurate cartilage removal and transverse plane adjustment when treating 1st tarsometatarsal (TMT) joint arthrodesis. The Paragon 28 (Englewood, CO, USA; www.paragon28.com) Lapidus Cut Guide System is designed to provide a reproducible and streamlined Lapidus procedure, the fusion of the first TMT joint intended to eliminate joint movement and correct the deformity around the first metatarsal. The system allows for controlled cuts that minimize the amount of length lost on the first ray by offering an array of Met-Cuneiform cut guides for resecting the precise amount of bone from the first TMT joint in order to restore the desired intermetatarsal angle.

The guide provides a means of achieving calculated bi-planar correction using transverse cuts, or tri-planar correction with the surgeons preferred method of de-rotation. Eight different angled guides are available in 0° and 8° – 20° of correction. All guides have a built-in 2° dorsal to plantar taper to aid in plantarflexion of the 1st ray, with two slot options available to minimize first ray shortening. The guides allow calculated bi-planar correction using transverse cuts, or tri-planar correction with the surgeons preferred method of de-rotation.

In addition, the system includes an alignment guide to determine if selected cut guide is appropriate for desired correction during; a built in dorsal to plantar taper on cuts made on the metatarsal in two different guide variations, reducing the likelihood of first ray dorsiflexion intraoperatively; a standard cleanup guide to resect an additional 1.5 millime-

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ters on either the metatarsal or cuneiform, if needed; and left/right 4° metatarsal cut guides provide a 4° dorsal to plantar taper for plantarflexion of the 1st metatarsal built into the cut. All guides are coated in titanium nitride for durability and strength.

Trying to create cuts that achieve a precise amount of intermetatarsal correction while simultaneously creating congruent surfaces to promote bony apposition at the fusion site is a technically challenging enterprise.

Avoiding plantar gapping by removing the plantar cartilage from the soft tissue attachments can also prove difficult. In addition, dorsiflexion of the first ray can occur during joint preparation as well, which can lead to transfer metatarsalgia.

Image: The Paragon 28 Lapidus Cut Guide (Photo courtesy of Paragon 28).

Mini Pacemaker Makes Heart Surgery Easier for Children new study describes how a tiny pacemaker, about the size of an almond, leads to shorter surgeries, faster recovery times, and reduced medical costs.

Developed by Medtronic (Dublin, Ireland; www.medtronic.com), in collaboration with researchers at Children’s National Health System (CNHS; Washington, DC, USA; www.childrensnational.org), the uniqueness of the prototype miniature pacemaker lies in the PeriPath, a twochannel, self-anchoring access port that allows surgeons to insert a video camera into one channel in order to directly visualize the entire procedure. A sheath, inserted through the second channel, is then used to access the pericardial sac to affix the miniature pacemaker’s leadlet onto the surface of the heart, under direct visualization.

The final step is inserting the pacemaker itself into the one centimeter incision and closing it, leaving a tiny scar instead of two large suture lines. In a preliminary study of the percutaneous procedure, median

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time from incision to implantation was 21 minutes, and the entire procedure took less than an hour on average. In contrast, pediatric openheart surgery can take up to several hours, depending on the child’s medical complexities. The prototype pacemaker was presented at the American Heart Association (AHA) scientific sessions, held during November 2018 in Chicago (IL, USA).

“Advancements in surgical fields are tending toward procedures that are less and less invasive. There are many laparoscopic surgeries in adults and children that used to be open surgeries, such as appendix and gall bladder removals,” said study presenter cardiology fellow Rohan Kumthekar, MD. “However, placing pacemaker leads on infants’ hearts has always been an open surgery. We are trying to bring those surgical advances into our field of pediatric cardiology to benefit our patients. As cardiologists and pediatric surgeons, our goal is to put a child’s health and comfort first.”

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Surgical Techniques

Dual Mobility Hip Implant Reduces Risk of Dislocation new study shows that modular dual mobility (DM) hip implants could reduce the risk of dislocation in patients who need revision surgery.

Researchers at the Hospital for Special Surgery (HSS, New York, NY, USA; www.hss.edu) and other joint replacement centers in the United States conducted a study involving 370 patients (average 65.8 years of age) who underwent revision hip replacement with a DM implant between April 2011 and April 2017. Clinical, radiographic, and patient reported-outcome information were collected for all patients; but to be included in the final report, patients needed to be seen for follow-up for at least two years after their surgery.

The results revealed that surgery with the DM implant resulted in a very low rate of instability for the revision patients (2.9%), with good functional improvement and a low rate of reoperation.

According to the researchers, there was a clear benefit provided by the DM implant in the first few years following revision surgery. The study was presented at the annual meeting of the American Association of Hip and Knee Surgeons, held during November 2017 in Dallas (TX, USA).

“Although the concept of dual mobility was originally developed in France in the 1970s, the technology is relatively new in the United

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Pelvic Floor Muscle Stimulator Treats Urinary Incontinence n externally worn stimulation device treats the root cause of stress urinary incontinence (SUI), rather than just managing the symptoms.

The Atlantic Therapeutics (Galway, Ireland; www.atlantictherapeutics. com) Innovo system is a non-invasive transcutaneous muscle exerciser, resembling a pair of cycling shorts, which uses electrical stimulation to deliver 180 precise, complete contractions to the pelvic floor muscles. During each 30-minute exercise session, the system strengthens and re-educates the network of muscles that control bladder function. A hand-held controller connected to the shorts allows users to increase the intensity of the stimulations, and a smartphone app is also available.

Innovo may be prescribed as a front-line therapy to those suffering SUI, or as a second line therapy to those that have previously failed physical therapy (in the form of supervised or unsupervised pelvic floor exercises, also known as Kegel exercises). A pivotal randomized controlled trial held in the United States demonstrated the efficacy and safety of the device, with 87.2% of patients treated dry or mild after a 12week treatment period, and 93% experiencing improvement in just four weeks. An earlier sham-controlled trial in Europe also demonstrated significant improvement across all study endpoints.

“For the first time, physicians in the United States can offer their patients a safe, clinically effective, noninvasive home-based treatment,” said Steve Atkinson, CEO of Atlantic Therapeutics. “Innovo therapy is a compelling treatment option for all those women who today simply suffer in silence from stress urinary incontinence.”

“Innovo offers a new frontline therapeutic option for the millions of American women living with stress urinary incontinence, and in a significant group could delay or prevent the need for higher risk surgery or medical intervention,” said Elizabeth LaGro, vice president of The Simon Foundation for Continence (Wilmette, IL, USA).

SUI is the loss of bladder control or involuntary loss of urine when coughing, laughing, sneezing, or during heavy lifting, or simply getting up from a chair. SUI is the most common type of incontinence suffered by women, especially older women and women who have given birth.

SUI also affects men, especially following prostate surgery. Other causes include weak pelvic muscles or a weak sphincter muscle; chronic coughing, smoking and obesity may also lead to SUI.

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States,” said senior author Geoffrey Westrich, MD, research director of the adult reconstruction and joint replacement service at HSS. “Our study found that the newer technology with modular dual mobility components offered increased stability, lowering the risk of dislocation, without compromising hip range of motion in patients having a revision surgery.”

A hip replacement implant is a ball-and-socket mechanism, designed to simulate a human hip joint and mimic its movement. Typical components include a stem that inserts into the femur, a ball that replaces the head of the thighbone, and a shell that lines the hip socket. The concept of DM refers to the bearing surface of the implant; DM provide two areas of motion within the artificial socket, instead of one, thus improving the range of movement and reducing the risk of dislocation.

Image: Examples of dual mobility hip prostheses (Photo courtesy of Zimmer Biomet).

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PRODUCT NEWS SURGICAL LIGHT

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IMAGING SYSTEM

OBJECT REMOVAL DEVICE

BenQ Medical Technology

Olympus

Summit Medical

The Dr. Lite Series reduces the amount of bacteria circulated and provides a more sterile working environment. Its lens reduces the heat generated and absorbs 99% of the undesired thermal radiation.

The EVIS EXERA III provides compatibility across multiple specialties including surgical endoscopy, gastroenterology, urology, and ENT. The platform supports over 100 different endoscopes and camera heads.

The Vacutract foreign body removal device safely and easily removes objects from nasal and ear cavities. It features a suction cup that conforms to almost any shape and works with standard tubing and system.

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Mechanical Attachment Enhances Colonoscopy Effectiveness novel device mounted on the tip of a colonoscope enhances mucosal visualization by holding back and unfolding colonic folds. The Olympus Medical (Olympus; Tokyo, Japan; www.olympus-global.com) Endocuff Vision is designed to maintain and maximize the viewable mucosa during endocosopic procedures by manipulating colonic folds using a single row of flexible retractable arms that evert and flatten the mucosa, providing an enhanced view of the entire colon. The arms also help to prevent slippage during withdrawal, stabilize the scope tip during examination and polypectomy, and reduce difficulties associated with looping.

Key features include four different color-coded sizes; a hard plastic body and firm, dry grip on the scope that prevents dislodgement and protect the distal tip of the colonoscope; and hinged arms that fit seamlessly into the device. The arms are designed so that they fall flat against the scope, creating a low profile for smooth forward movement during intubation. Upon withdrawal, the hinged arms expand to gently flatten large mucosal folds, bringing elusive areas into view. The soft, flexible arms provide just the right amount of force to be effective without causing mucosal trauma.

A recent study at NYU Langone Medical Center (New York, NY, USA; www.med.nyu.edu) that assessed 200 people 40 years and younger undergoing screening or surveillance colonoscopy randomly assigned 101 to colonoscopy with the device and 99 to standard colonoscopy. Demographic characteristics were similar in the two

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groups, as was bowel preparation quality. The results revealed that inspection time with the Vision was on average nearly two minutes faster than in the standard group, with no reduction in adenoma detection rate (ADR). The study was presented at American College of Gastroenterology (ACG) annual scientific meeting, held during October 2018 in Philadelphia (PA, USA).

Image: The Endocuff Vision comes in four color-coded sizes (Photo courtesy of Olympus).

Interbody Fusion Implant Fully Integrates with Vertebral Bodies new minimally invasive anterior lumbar interbody fusion (ALIF) device provides support and integrated fixation.

The Camber Spine Technologies (Wayne, PA, USA; www. cambermedtech.com) ENZA-A Titanium ALIF system is an interbody fusion device indicated for use with autogenous bone graft in patients suffering from degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. The implants may be placed via a laparoscopic or an open anterior approach, and feature two anchor plates – housed within the three-dimensional (3D) printed titanium body – that are deployed into adjacent vertebrae to provide fixation. The use of supplementary fixation systems is also recommended.

ENZA-A Titanium ALIF has a roughened surface texture designed to encourage bone growth onto the cranial and caudal surfaces of the device. The upper and lower facets are deliberately designed with pores that average a large 500 microns in diameter, the optimal environment for bone ingrowth. In addition, the implant has multiple openings that

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allow large volumes of autogenous bone graft to be easily packed inside, further facilitating fusion. Proprietary inline instrumentation is used to insert the device, deploy the anchor plates, and lock it in place.

“ENZA-A leverages two of Camber Spine’s highly innovative platform technologies,” said Daniel Pontecorvo, CEO of Camber Spine Technologies. “The vast interest and success of our first generation ENZA with Duo Presa anchor technology and our line of SPIRA products with Surface By Design inspired us to combine their defining attributes to create this next generation ENZA-A Titanium ALIF.” Interbody devices are designed to replace the intervertebral disc of the spine, enhancing stability in the region while the spine fuses. Over time, the packed bone graft material is gradually replaced by natural bone. Fusion procedures also typically use a posterior fixation device to the associated level, since the surgeons will implant interbody devices from an anterior approach and flip the patient over to implant a posterior pedicle screw device. This combination increases fusion success.

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Surgical Techniques

Magnetic Heart Pump Helps Heart Failure Patients n innovative left ventricular assist device (LVAD) can help advanced heart failure (HF) patients who are not eligible for heart transplants enjoy a better quality of life for the rest of their days.

The Abbott (Abbott Park, IL, USA; www.abbott.com) HeartMate 3 consists of a magnetically levitated (MagLev) centrifugal-flow pump implanted above the diaphragm, next to the native heart; the pump is attached to the aorta, thus leaving natural circulation in place. The system can pump up to 10 liters of blood per minute, using magnets keep the rotor in place, reducing trauma to blood cells passing through the pump while improving flow. The pump also adds consistently timed flow gaps in order to generate an artificial pulse which further reduces adverse events, including combating the formation of thrombii.

The MagLev system is calibrated tens of thousands of times per second to ensure it stays suspended and centered within the pump, no matter the speed settings used by a physician, ensuring that the pump is performing effectively. The patient himself wears an external, wearable controller, the system driveline, and a battery that powers the pump. Recent clinical data shows that patients implanted with the Abbot HeartMate 3 LVAD enjoyed a survival rate of 82.8% at two years follow-up, and that rates of suspected pump thrombosis were just 1.1% at two years.

“We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes,” said Mike Pederson, senior vice president of Abbott’s Cardiac Arrhythmias and HF business.

“The unique design of the HeartMate 3 LVAD, with its full MagLev technology, takes an established innovation and improves upon it in meaningful ways to help people with advanced heart failure live fuller lives.”

“Approximately a quarter of a million people are living with advanced heart failure, and many of these people will need a heart transplant; however, only a few thousand will receive a new heart,” said Nir

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Rheoplasty System Targets Bronchitis Mucus Plugging n innovative electrosurgical system targets the cells responsible for mucus hypersecretion in the airways, providing relief to chronic bronchitis patients.

The Gala Therapeutics (Menlo Park, CA, USA; www.galatherapeutics.com) RheOxh system is an ablation catheter and complementary minimally invasive procedure that is designed to reduce cough and mucus production using a bronchoscope inserted through the mouth into the lungs. Once in place, the RheOx catheter delivers short bursts of high frequency, short duration electrical energy to the inner walls of the bronchi, causing mucus-producing cells to break open and die. Within days, the abnormal cells in the airway epithelium and sub-mucosal tissue layers are replaced by new cells, which produce less mucus.

The treatment involves two sessions delivered under general anesthesia. The right lung is treated during the first treatment session, and the left lung is treated at the second treatment session, approximately one month later. The RheOxh system is an experimental device that is currently undergoing an early feasibility study (EFS) at the University of Pittsburgh Medical Center (UPMC; PA, USA), under a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE).

“Patients with chronic bronchitis suffer daily with mucus hypersecretion and cough. We developed the bronchial rheoplasty procedure to directly treat the abnormal airway cells responsible for chronic bronchitis, which are not impacted by inhaled medications,” said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics.

Chronic bronchitis is the most common subtype of chronic obstructive pulmonary disease (COPD), and is associated with increased cough, excessive phlegm, and shortness of breath for more than three months of each year. It mainly affects smokers and former smokers, but secondhand smoke, vaping, exposure to airborne chemicals, pollution, and other irritants can also contribute to the disease. Despite treatment with inhalers, many patients have persistent symptoms.

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Uriel, MD, of the University of Chicago Medicine (IL, USA). “Destination therapy approval for Abbott’s HeartMate 3 device now gives these patients new hope that they can receive a heart pump clinically proven to mitigate challenges we’ve historically confronted with this therapy – stroke and blood clotting – while also offering survival rates on par with transplant.”

An LVAD is intended to complement a weakened heart by providing circulatory support, thus helping to maintain or improve blood flow to the kidneys, liver, brain and other organs. One end is attached to the left ventricle, and other is attached to the aorta; blood flows from the ventricles into the pump and is then ejected out of the device and into the aorta. LVADs are used as destination therapy or as a bridge-to-transplant, allowing the patient to be discharged from the hospital and lead a more normal and fuller life.

Image: The MagLev HeartMate 3 LVAD system (Photo courtesy of Abbott).

PRODUCT NEWS MEDICAL DISPLAY

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HEALTHCARE COMPUTER

COMPUTER CART

Ampronix

Zebra Technologies

CompuCaddy

The MODALIXX G202MDL offers user-friendly OSD, low power consumption and a wide viewing angle. It is considered ideal for cath lab, MRI, CT, CR, PET scanners, RF rooms, C-arm and portable X-rays.

The MC40 offers enterprise-class durability, security and a comprehensive set of features. The pocketsized computer improves patient safety, patient experience and staff productivity.

The Fusion All In One accommodates any computer, as well as LCD flat panel monitor paired with a mini PC. It is ideal for users looking for advanced ergonomics and performance from a mobile power system.

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Machine Learning Detects Cervical Cancer cont’d from cover

(CMOS) sensor with 13 megapixel resolution; and a powerful 4X optical/16X digital zoom magnification lens that provides a working distance of 225-400 mm. The rechargeable, longlasting battery provides up to 10 hours of continuous use.

Secure software allows for real-time visualization of the cervix, with enhancement filters that can be applied directly to captured images. Secure online data management allows users to document cases, add annotations, and export the information to an electronic medical record (EMR), simplifying the medical workflow. In addition, a cloud-based information system (EVA Cloud) provides secure access to real time data so as to monitor provider utilization, identify cases reviewed, collect anonymized patient statistics, and enhance quality control and quality improvement opportunities.

The EVA Colposcope, developed by MobileODT (Tel Aviv, Israel; www.mobileodt.com) is currently used in 29 countries, based on

smartphone technology and augmented intelligence cervical cancer detection to improve cancer identification. The augmented AVE algorithm can identify problematic lesions with greater reliability than traditional Pap cytology testing, and with a higher level of accuracy than expert human colposcopists, as validated by the U.S. National Cancer Institute (NCI, Rockville, MD, USA; www.cancer.gov) and the National Library of Medicine (Bethesda, MD, USA).

“For this new technology to move out of the laboratory and into healthcare practice, a practical application was needed. The EVA System is the only colposcope on the market ready to deliver AVE at the point-of-care,” said Ariel Beery, CEO of MobileODT. “We are excited by the new AVE algorithm and the promise it holds in fighting cervical cancer. Our team is proud to make available an AVE enabled colposcope to reach more women and save more lives.”

Cervical cancer is the fourth most common cancer in women, with more than 500,000 new cases occurring annually worldwide. The

two most common detection methods include the Pap smear, which can be performed by a non-specialist, and colposcopy, which requires visualization of the cervix using a speculum, a colposcope, and a trained professional to administer the test. Colposcopes and people who know how to use them are difficult to find in many low-income regions.

Image: The EVA3 mobile colposcope, with smartphone attached (Photo courtesy of MobileODT).

Largest Artificial Intelligence Powered Medical Research Network Launched he newly launched OWKIN (New York, NY, USA; https:// owkin.com) Loop Network, which includes over 30 leading international hospitals and research institutions across the United States and Europe, has been designed to help researchers train predictive models on real-world data at scale, and transfer the accrued knowledge to a collective intelligence. Members include Cleveland Clinic (OH, USA), Mount Sinai (New York, NY, USA), and Groupe AP-HP, a cluster of 39 hospitals in France, among others.

The Loop Network thus creates an ecosystem that shares the collective knowledge, benefitting research organizations, partner hospitals, and pharmaceutical companies in advancing research and development in oncology, cardiovascular, neurodegenerative, and autoimmune diseases.

Projects undertaken by the network include the training of a predictive model identifying new quantitative biomarkers associated with prognosis in a rare cancer, the prediction of brain age from magnetic resonance im-

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aging (MRI), and prediction of gene expression profiles from slide images as a marker of response to immunotherapy. “Access to patient data is critical for improving medical research, but the current patient data brokerage system hinders knowledge-sharing and risks patient data privacy, resulting in knowledge silos at individual hospitals,” said Thomas Clozel, MD, co-founder and CEO of OWKIN. “If we can transform the world’s clinical data into broadly accessible research knowledge, we believe we can fundamentally advance medical research and have an incredibly powerful impact on solving the most important medical challenges.”

“We are excited to be working with OWKIN to apply AI algorithms to clinical data for mesothelioma research,” said Françoise Galateau-Sallé, MD, principal investigator at Centre Léon Bérard (Lyon, France; www.centreleonberard.fr). “AI models identified a new subgroup of patients that are poor responders to the standard of care and potential good candidates for immunotherapy.”

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Medical Image Viewing Platform to Integrate with Google Cloud

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nternational Medical Solutions (IMS; Mississauga, Canada; www.imstsvc.com) will provide Google (Mountain View, CA, USA; www.google.com) Cloud account users with the ability to upload, manage, distribute, view, annotate, save, download and delete their medical images in a secure environment.

Similar to Google Drive, the IMS Cloud View will connect directly to any Google Cloud account and enable users to access full fidelity medical images, with no installation required. The underlying imaging technology allows medical professionals to engage in interactive, web-based reviews, on any device, using full fidelity digital imaging and communications in medicine (DICOM) images. IMS also plans to optimize the global reach of Google Cloud Platform and expand its current serverless viewing technology in parallel with its artificial intelligence (AI) and machine learning initiatives.

Features include intuitive imaging tools, hanging protocols, presets, and customized toolbars that facilitate image uploading, viewing, annotation, saving, and exporting. Uploaded NE DES W studies of interest can be immediately IGN downloaded for instant viewing, with all annotations and markups saved and displayed immediately, and can also be shared with colleagues with a quick email link. A full tool set enWORLD’S MEDICAL PRODUCT MARKETPLACE ables quick content creation, including for educational purposes, such as quiz-style multiple choice, true/false, anatomical, or informative questions SIGN UP alongside full-resolution medical imFOR FREE! ages.

“Clients tell us that they like IMS Cloud View because our technology is the missing piece that completes the viewer value chain. It is simple to use, reliable in all types of network conditions, and gives them the freedom and flexibility to read, assess, mark-up and save, import, share, and send secure links from any device, anytime, anywhere,” said Vittorio Accomazzi, CTO of IMS. “They maintain ownership of their data in Google Cloud and we store it in a DICOM compliant, non-proprietary way. We believe IMS Cloud View and Google Cloud Platform will revolutionize the medical imaging industry.”

Google Cloud Platform is a suite of cloud computing services that provides infrastructure as a service, platform as a service, and serverless Connecting Buyers with computing environments. It runs on Suppliers Worldwide the same infrastructure that Google uses internally for its end-user prodReach new sources of supply ucts, such as Google Search and Identify latest products and technologies YouTube. Alongside a set of manageSend inquiries directly to suppliers ment tools, it provides a series of Receive latest product alerts modular services including computChat live with suppliers ing, data storage, data analytics, and machine learning.

TradeMed provides a sophisticated yet easy-to-use global B2B platform for sourcing medical

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Image: Homepage of IMS Cloud View (Courtesy of International Medical Solutions).

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HospiMedica International April-May/2019

equipment. TradeMed connects buyers and sellers worldwide through a safe, secure and dynamic network. Solely dedicated to medical products, TradeMed is the premier choice for medical suppliers, hospital decisionmakers and buyers worldwide, regardless of size or budget.

PRODUCT NEWS POC SOLUTIONS

To receive prompt and free information on products, log on to www.LinkXpress.com or fill out reader service form located on last page, or scan the QR code on your mobile device

3D IMAGING SYSTEM

POC TERMINAL

Abbott Diagnostics

Olympus

ADVANTECH iHealthCare

The AegisPOC Point of Care Management Solutions is a web-based platform that connects POC devices with a lab. It allows labs to manage and share data from POC devices on one flexible and scalable option.

The 3D Imaging System features an articulating, chipon-tip design and dual optical channels to enable critical anatomical views in 2D and 3D. It provides improved speed, accuracy and precision for surgical tasks.

The POC-W243L features a slim design and IPS display that allows users to view the images from any angle. The panel computer housing is waterproof and dust-proof to aid in infection control.

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Eye-Tracking System Exposes Brain Health Issues dvanced eye-tracking technology records, views, and analyzes eye movements to help identify visual and brain impairments.

The RightEye (Bethesda, MD, USA; www.righteye.com) RightEye System is a portable, all-in-one solution for vision-derived health screening, tracking eye movements and correlating them to health issues. The system is intended for primary care optometrists, rehabilitation facilities, professional sports teams, and the U.S. military.

The system, which includes the RightEye EyeQ tests, reports, and training tools, has various applications, including: Functional Vision Screening, a vision test that helps quickly and objectively identify a host of functional vision issues that affect quality of life, with automatic recommendation of computer-based exercises patients can do at home. Reading Assessments - RightEye EyeQ tracks reading proficiency in real time, identifying hidden vision issues associated with learning difficulties. Sports Vision Assessment and Training – As the Sports Vision EyeQ test identifies opportunities to strengthen performance-related aspects of vision, the accompanying Sports Vision Trainer offers personalized exercises to athletes looking to improve coordination and reaction times. Brain Health - RightEye Brain Health EyeQ showcases the severity levels of vision skill problems and how this may relate to brain performance. It also provides computer-based vision exercises to help address oculomotor issues.

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Image: Eye movement tracking can help detect neurological issues (Photo courtesy of RightEye).

Amazon Launches Connected Medical Device Brand mazon (Seattle, WA, USA; www.amazon.com) has launched an exclusive line of consumer-use medical devices focused on helping consumers manage their diabetes or cardiovascular conditions. The online retail leader partnered with the Arcadia Group (Atlanta, GA, USA; www.arcadiagp.com) to launch the Choice product line, composed of blood glucose and blood pressure monitors sold directly to consumers, with both standard and Bluetooth-enabled models offered. The Choice wireless blood glucose monitor, which costs just USD 23 on the Amazon website, is a tiny, stylish device that provides accurate results in just five seconds. A more basic model is available, without wireless compatibility, for USD 11.

The Choice wireless blood glucose monitor includes the monitor, a lancing device, 10 lancets, a carrying case, a quick start guide and owner’s manual, and pre-installed batteries. The device wirelessly transmits data to a smartphone through the free Amazon diabetes management app, called AgaMatrix Diabetes Manager, compatible with both iOS and Android devices, which stores, manages, and shares diabetes information with healthcare providers. No prescriptions or insurance required.

The monitor works only with Choice brand test strips, sold separately.

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The Choice wireless blood pressure monitor is offered in three versions.

An upper arm version provides easy one-button operation with expanded smartphone support. The device wirelessly connects to the free Choice blood pressure app, which displays readings, graphs, and tips on managing hypertension. The cuff fits most arm diameters, providing gentle inflation for a more comfortable experience; a multi-user model that can monitor up to four people is also available. Two basic models are available without Bluetooth connectivity, an upper arm version and a wrist version.

“Consumers no longer need to drive to a store to stand in-line and purchase their medical devices and supplies. Now, in the privacy of their home, consumers can review, compare, and purchase the products of their choice The Choice brand is all about accessible wellness,” said Bob Guest, CEO of the Arcadia Group. “No insurance is required; therefore, customers have the freedom of choice. They will no longer be told by their insurance company what brand they can buy. Choice is freedom.”

The Choice line is a private label of the Arcadia Group, which will be sold only on Amazon. The Arcadia group has also developed similar health brands for Walmart (Bentonville, AR, USA; www.walmart.com) and other companies.

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Industry News

Hybrid OR Market Seen to Grow at 4.6% per year he global hybrid operating room market is expected to grow at a steady CAGR of 4.60% from USD 661.8 billion in 2017 to USD 828.1 billion by 2022. The market growth is expected to be driven by the rising number of neurological disorder patients, growing demand for minimally invasive neurovascular surgeries, and rapid growth in technological advancements, especially in the field of medical robotics. Additionally, hybrid operating rooms are now used for providing treatment in thoracic, neurological, orthopedic, and cardiovascular diseases. The inclusion of robot-assisted surgeries and growing patient preference for effective and affordable surgical treatment has intensified the demand for hybrid operating rooms.

These are the latest findings of Transparency Market Research, (Al-

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bany, NY, USA; www.transparencymarketresearch.com), a global market intelligence company providing business information reports and services.

Increasing government support for research and development activities and the installation of novel equipment in healthcare set-ups has further aggravated demand and created new growth prospects in the hybrid operating room market. However, the high cost involved in the installation and deployment of hybrid operating rooms is a key factor that could restrain market growth. Moreover, the complicated procedures involved in the installation of hybrid operating equipment could further hamper the growth of the hybrid operating room market. Nevertheless, the rising application of hybrid operating equipment could help minimize the impact of these restraints and accelerate market demand.

Anesthesia and Respiratory Devices Market to Reach USD 38 Billion by 2023 he global anesthesia and respiratory devices market is expected to grow at a CAGR of 7.2% from USD 25.21 billion in 2017 to USD 38.29 billion by 2023, driven by the rising prevalence of respiratory diseases, increase in the number of surgical procedures, surge in pollution levels, higher tobacco consumption, rapid urbanization and supportive government policies. However, risks related to therapeutic and diagnostic devices for neonates and the low adoption rate of new technologies will restrain the market growth. Nevertheless, an increase in the demand for therapeutic devices for homecare settings and a surge in healthcare expenditures will create new opportunities in the global anesthesia and respiratory devices market.

These are the latest findings of Allied Market Research (Portland, OR, USA; www.alliedmarketresearch.com), a full-service market re-

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Use of Handheld Ultrasound Scanners For Point-of-Care Shows Rapid Growth he global handheld ultrasound scanners market was valued at USD 62.2 million in 2017 and is projected to grow at a CAGR of 17.0% from 2018 to 2026. The market growth is expected to be driven by various factors such as growing inclination towards handheld ultrasound scanners for point-of-care diagnostics; lower capital investment required for handheld ultrasound scanners in comparison to conventional ultrasound devices; growing number of diagnostics centers and ambulatory care centers across the world; and portability and cloud connectivity features offered by these handheld devices. These are the latest findings of Research and Markets, (Dublin, Ireland; www. researchandmarkets.com), a global market research company.

Handheld ultrasound scanners, which are used for imaging internal organs, cardiovascular, and gynecology imaging, are becoming increasingly popular among clinicians across the world for point-of-care diagnosis. Over the last decade, the handheld ultrasound scanners market has flourished with several major medical devices companies introducing portable and handheld ultrasound devices. The uptake of handheld ultrasound units is increasing at a fast pace owing to low market entry barriers as the regulatory scenario for portable ultrasound still remains undefined in several regions. Moreover, advancements in consumer electronics have made it inexpensive to design and manufacture handheld ultrasound devices.

Based on technology, 2D ultrasound scanners held the largest share in the global handheld scanners market, led by the growing demand for efficient and better imaging quality, rapid introduction of handheld 2D ultrasound products by a majority of manufacturers and higher demand for these devices among physicians. However, there is growing inclination among healthcare practitioners towards handheld 3D ultrasound scanners as they are less inexpensive in comparison to conventional cart-based ultrasound scanners and provide similar image quality.

Hence, 3D handheld ultrasound scanners are expected to grow at a steady rate during the forecast period due to its high application in pointof-care diagnostics.

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search and business consulting firm.

Based on product type, the respiratory devices segment is the most lucrative and held nearly three-fifths of the total market share in 2017, owing to the high prevalence of respiratory diseases and availability of advanced respiratory devices. The segment is expected to maintain its dominance and grow at the fastest CAGR of 7.3% during the forecast period, driven by a significant rise in pollution across the world, lack of awareness about the utilization of masks for protection against aerosols and other particulate matter, and rising prevalence of respiratory diseases such as asthma, respiratory infections, and tuberculosis. Based on end user, the hospitals segment dominates the anesthesia and respiratory devices market, although the clinics segment is expected to grow at the highest CAGR during the forecast period.

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MAY 2019 EuroCMR 2019 – 17th Annual Meeting of the European Association of Cardiovascular Imaging (EACVI). May 2-4; Venice, Italy; Web: www.escardio.org/EACVI ESTES 2019 – 20th European Congress of Trauma & Emergency Surgery. May 5-7; Prague, Czech Republic; Web: www.estesonline.org 2019 ARRS Annual Meeting – American Roentgen Ray Society. May 5-10; Honolulu, HI, USA; Web: www.arrs.org Vietnam Medi-Pharm 2019. May 8-11; Hanoi, Vietnam; Web: vietnammedipharm.vn ISMRM 2019 – 27th Annual Meeting of the International Society for Magnetic Resonance in Medicine. May 11-16; Montreal, Canada; Web: www.ismrm.org ESPR 2019 – 55th Annual Meeting of the European Society of Paediatric Radiology. May 14-18; Helsinki, Finland; Web: www.espr.org CMEF Spring 2019 – China International Medical Equipment Fair. May 14-17; Shanghai, China; Web: www.cmef.com.cn KIHE 2019 – Kazakhstan International Healthcare Exhibition. May 15-17; Almaty, Kazakhstan; Web: kihe.kz ATS 2019 International Conference – American Thoracic Society. May 17-22; Dallas, TX, USA; Web: conference.thoracic.org ECE 2019 – 21st European Congress of Endocrinology. May 18-21; Lyon, France; Web: www.ese-hormones.org ASNR 2019 – 57th Annual Meeting of the American Society of Neuroradiology. May 1823; Boston, MA, USA; Web: www.asnr.org MedtecLIVE 2019. May 21-23; Nuremburg, Germany; Web: www.medteceurope.com Hospitalar 2019. May 21-24; Sao Paulo, Brazil; Web: www.hospitalar.com

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EAPC 2019 – 16th World Congress of the European Association for Palliative Care. May 2325; Berlin, Germany; Web: www.eapc-2019.org Heart Failure 2019 – World Congress on Acute Heart Failure. May 25-28; Athens, Greece; Web: www.escardio.org/heartfailure Africa Health 2019. May 28-30; Johannesburg, South Africa; Web: www.africahealthexhibition.com Deutscher Röntgenkongress – 100th Annual Meeting of the German Roentgen Society.

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International Calendar FIME 2019 – Florida International Medical Exhibition. Jun 26-28; Miami Beach, FL, USA; Web: www.fimeshow.com Medical Taiwan 2019. Jun 27-30; Taipei, Taiwan; Web: www.medicaltaiwan.com.tw

cine. Sep 28-Oct 2; Berlin, Germany; Web: www.esicm.org ESMO 2019 – Annual Congress of the European Society for Medical Oncology. Sep 29–Oct 1; Barcelona, Spain; Web: www.esmo.org

JULY 2019 INAC 2019 – 5th Conference of the International Neonatology Association. Jul 12-14; Tijuana, Mexico; Web: 2019.worldneonatology.com

AUGUST 2019 WCS 2019 – 48th World Congress of Surgery.

Aug 11-15; Krakow, Poland; Web: www. wcs2019.org

SEPTEMBER 2019 ESC Congress 2019 – European Society of Cardiology. Aug 29-Sep 4; Paris, France: Web: www.escardio.org Medical Fair China 2019. Sep 6-8; Suzhou, China; Web: www.medicalfair.cn WFUMB 2019 – 17th World Federation for Ultrasound in Medicine and Biology Congress.

Sep 6-9; Melbourne, Australia; Web: www. wfumb2019.org Medical Fair Thailand 2019. Sep 11-13; Bangkok, Thailand; Web: www.medicalfair-thailand.com ESRA 2019 – 38th Annual Congress of the European Society of Regional Anaesthesia and Pain Therapy. Sep 11-14; Bilbao, Spain; Web: esra-congress.com CIRSE 2019 – Annual Congress of the Cardiovascular and Interventional Radiological Society of Europe. Sep 22-25; Lisbon, Portugal; Web: www.cirse.org ESVS 2019 – 33rd Annual Meeting of the European Society for Vascular Surgery. Sep 2327; Hamburg, Germany; Web: www.esvs.org Medic East Africa 2019. Sep 24-26; Nairobi, Kenya; Web: www.mediceastafrica.com ExpoMedical 2019. Sep 25-27; Buenos Aires, Argentina; Web: www.expomedical.com.ar 2019 SDMS Annual Conference – Society of Diagnostic Medical Sonography. Sep 26-29; National Harbor, MD, USA; Web: www.sdms.org ERS International Congress 2019 – European Respiratory Society. Sep 28-Oct 2; Madrid, Spain; Web: www.ersnet.org ECISM LIVES 2019 – 32nd Annual Congress of European Society of Intensive Care Medi-

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Oct 13-16; Berlin, Germany; Web: www.isuog.org 14th World Congress of Intensive Care 2019 – World Federation of Societies of Intensive and Critical Care Medicine. Oct 14-18; Melbourne, Australia; Web: www.worldcongress intensivecare2019.com UEG Week 2019 – United European Gastroenterology. Oct 19-23; Barcelona, Spain; Web: www.ueg.eu ESCR Annual Scientific Meeting 2019 – European Society of Cardiovascular Radiology.

Oct 24-26; Antwerp, Belgium; Web: www.escr.org CMEF Autumn 2019 – China International Medical Equipment Fair. Oct 29-Nov 1; Shanghai, China; Web: www.cmef.com.cn

NOVEMBER 2019 43rd World Hospital Congress of the International Hospital Federation 2019. Nov 7-9; Muscat, Oman; Web: worldhospitalcongress.org APSR 2019 – 24th Congress of the Asian Pacific Society of Respirology. Nov 14-17; Hanoi, Vietnam; Web: www.apsresp.org MEDICA 2019. Nov 18-21; Dusseldorf, Germany; Web: www.medica-tradefair.com

DECEMBER 2019 RSNA 2019 – Annual Meeting of the Radiological Society of North America. Dec 1-6; Chicago, IL, USA; Web: www.rsna.org

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