HospiMedica International December 2020

WORLD’S CLINICAL NEWS LEADER Vol.38 No.6 • 12/2020-1/2021

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Respiratory Device Oxygenates Blood

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radical respiratory support system oxygenates blood and removes carbon dioxide (CO2), preventing the need for mechanical ventilation.

The AXT system provides an alternative to highly invasive mechanical ventilation systems,

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Lower Ventilation Pressure Sufficient for Healthy Lungs

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ow positive end-expiratory pressure (PEEP) protocols for ICU patients without acute respiratory distress syndrome (ARDS) are no worse than higher levels, according to a new study.

Researchers at Amsterdam University Medical Centers

(AMC; The Netherlands; www. amc.nl), Hospital Israelita Albert Einstein (São Paulo, Brazil; www. einstein.br), and other institutions conducted a study involving 980 patients (median age 66, 36% women) in eight ICUs in the Netherlands to determine if a

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The Year of COVID: Top 20 COVID -19 Care & Treatment Milestones of 2020

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Digital Chest Drain Prevents Contamination

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n innovative chest drainage and monitoring system effectively impedes aerosolized viral and bacterial particles from spreading.

The Medela (McHenry, IL, USA) Thopaz+ Digital Chest Drainage and Monitoring System is a compact, lightweight device with a convenient carrying handle and a long-life battery that support patient recovery and outcomes

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novel stentriever can safely remove blood clots from intracranial vessels following ischemic stroke, helping to restore perfusion.

The Rapid Medical Tigertriever XL thrombectomy system is an adjustable, fully visible clot retriever designed to treat ischemic stroke in vessels up to nine mm in diameter and up to 53 mm in length. It is

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Thrombectomy System Tackles Large Clots

020, a year of crisis defined by the COVID-19 pandemic and its unprecedented healthcare challenges, is now behind us. Thanks to the pharma industry mobilization, mass scale vaccinations are expected to control the pandemic in the course of 2021. Our 2020 Annual Review focuses on the top 20 milestones that helped hospitals and clinics worldwide cope with the COVID-19 crisis during the year.

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INSIDE

Immersive Entertainment System Eases MRI Scan Anxieties

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COVID-19 Update. . . . . 4

novel entertainment platform helps alleviate the apprehension and claustrophobia associated with a magnetic resonance imaging (MRI) procedure by transporting patients to a breathtaking virtual world.

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

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Machine Learning Aids Identification of Large Vessel Occlusions

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3D convolutional neural network (CNN) helps find large-vessel occlusions (LVOs) on head and neck CT angiography (CTA) exams, according to a new study. Researchers at Rhode Island Hospital (Providence, USA; www.

rhodeislandhospital.org conducted a study to assess the performance of a deep learning (DL) algorithm in identifying LVOs on CTA studies. To this end they trained the CNN with more than 7,000 exams for LVO, and tested Cont’d on page 12

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

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

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

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COVID-19 Care & Treatment: Top 20 Milestones of 2020

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The Year of COVID: Top 20 COVID-19 Care & Treatment Milestones of 2020

020, a year of unprecedented crisis defined by the COVID-19 pandemic and its immense healthcare challenges, is now behind us. Thanks to the pharma industry’s mobilization and its remarkable achievement in rapidly developing a number of successful vaccines within a short window of less than a year, mass scale vaccinations are now expected to control the pandemic in the course of the coming year.

Our 2020 Annual Review below focuses on the Top 20 COVID-19 Care and Treatment Milestones that helped hospitals and clinics worldwide in coping with the healthcare crisis and trying to save as many lives as possible.

For reference to our comprehensive coverage of COVID-19 news and developments in the course of the past year, the reader is invited to turn to previous issues of HospiMedica or visit our website at www.hospimedica.com.

Infection Risk to Medical Personnel

roid treatment) as potential treatment for COVID-19 has shown that the drug had a meaningful benefit. The study of dexamethasone was a part of the RECOVERY (Randomized Evaluation of COVid-19 thERapY) trial to test a range of potential treatments for COVID-19 that enrolled over 11,500 patients from over 175 NHS hospitals in the UK. Based on the results, one death would be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone.

JULY Revolutionary COVID-19 Patient Isolation Transport System Minimizes

A new infectious disease containment system from Numotech, Inc. (Northridge, CA, USA; www.numobag.com) could provide protection to critical first responders and medical staff against infectious or contagious disease, such as COVID-19, while transporting or monitoring an infected patient. The new production-ready Numobag Disposable Isolation System (N-DIS) is a portable, easily deployed, low-cost, single-use, disposable infectious disease containment system designed to minimize risk to the patient and front-line personnel, while allowing patient monitoring and safe transport fully encapsulated in a medical-grade, oxygen-enriched, clear polyethylene membrane.

MAY Gilead’s Remdesivir Receives US FDA EUA for Treatment of COVID-19 Gilead Sciences’ (Foster City, CA, USA; www.gilead.com) investigational antiviral drug remdesivir has been granted emergency use authorization (EUA) to treat COVID-19 by the US Food and Drug Administration (FDA). The EUA is based on available data from two global clinical trials – the National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, including those who were critically ill, and Gilead’s global Phase 3 study evaluating 5-day and 10-day dosing durations of remdesivir in patients with severe disease.

In August, the FDA broadened the scope of the existing EUA for remdesivir to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.

In October, the FDA approved remdesivir for the treatment of patients with COVID-19 requiring hospitalization, making it the first and only approved COVID-19 treatment in the US.

JUNE Steroid Drug Dexamethasone Hailed As ‘Major Breakthrough’ In Treating Coronavirus A randomized clinical trial to test low-dose dexamethasone (a ste-

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AUGUST FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential COVID-19 Treatment The US Food and Drug Administration (FDA Silver Spring, MD, USA; www.fda. gov) has issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. The FDA had initially facilitated access to convalescent plasma for treating COVID-19 by using pathways that included traditional clinical trials and emergency single-patient investigational new drug (IND) applications. Based on scientific evidence available, the FDA has now concluded that convalescent plasma may be effective in treating COVID-19 and that its known and potential benefits outweigh its known and potential risks.

SEPTEMBER WHO Recommends Corticosteroids for Treatment of Critically Ill COVID-19 Patients after New Findings Emerge The World Health Organization (Geneva, Switzerland; www.who.int) has published guidance for clinicians and health care decision-makers that recommends systemic corticosteroids for the treatment of patients with severe and critical COVID-19. WHO partnered with investigators of seven randomized clinical trials evaluating three steroids, dexamethasone, hydrocortisone and methylprednisolone, in more than 1,700 patients. The WHO then combined the data from these seven trials with data from the RECOVERY trial which had published a preliminary report on the impact of corticosteroids. On the basis of the data, the WHO has recommended systemic corticosteroids rather than no systemic corticosteroids for the treatment of patients with severe and critical COVID-19, but has suggested not to use corticosteroids in the treatment of patients with non-severe COVID-19.

OCTOBER COVID-19 Machine-Learning Algorithm Secures FDA Emergency Use Authorization COViage, a machine learning algorithm developed by Dascena, Inc. (Oakland, CA, USA; www.dascena.com), has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for use by healthcare providers in the hospital setting for adult patients with confirmed COVID-19 to assist with the early identification of patients likely to experience hemodynamic instability or respiratory decompensa-

tion. COViage, a Hemodynamic Instability and Respiratory Decompensation Prediction System, analyzes patient data from electronic health records (EHR) systems and gives healthcare providers advance notification of patients who are predicted to experience unstable blood pressure or respiratory decline requiring mechanical ventilation.

Researchers Find Existing Medications that Could Speed Recovery of COVID-19 Patients Researchers at the University of New Mexico (UNM Albuquerque, NM, USA; www. hsc.unm.edu) who combed through a “library” of previously approved drugs believe they have identified a medication with the potential to help speed a COVID-19 patient’s recovery from SARS-CoV-2 infection. The researchers have reported that an older anti-malarial drug called amodiaquine was effective in eradicating the SARS-CoV-2 virus in test tube experiments. Amodiaquine was one of three promising candidates identified in a process that entailed studying the molecular characteristics of about 4,000 drugs approved for human use by the US Food and Drug Administration (FDA) and other agencies. The other two drugs – an anti-psychotic called zuclophentixol and a blood pressure medication called nebivolol – also cleared the virus in the experiments.

Study Finds Corticosteroids to Be Most Effective Treatment for Cytokine Storm in COVID-19 Patients Researchers from The Feinstein Institu tes for Medical Research (New York, NY, USA; www.feinstein.northwell.edu) and Northwell COVID-19 Research Consortium have identified the most effective immunomodulatory therapies to treat COVID-19 patients with evidence of cytokine storm and improve patient survival. Their study showed that the most effective treatment was the combination of corticosteroids - such as dexamethasone – with tocilizumab when compared to standard of care.

Additionally, there was an improvement if corticosteroids were used alone, or in combination with tocilizumab or anakinra when compared with standard of care.

The researchers hope that the findings are useful for frontline providers to care for severely ill COVID-19 patients and to aid in the future design of large randomized controlled clinical trials, the gold standard of medical research.

Closed-Circuit Nebulizer Technology to Help Deliver Potential COVID-19 Inhaled Therapies A closed-circuit nebulizer technology developed by Aerogen (Galway, Ireland; www. aerogen.com) that is being used in hospitals to deliver aerosolized medication to critically ill ventilated COVID-19 patients, will help ensure safe delivery of inhaled antiviral

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ISSN 0898-7270

Vol.38 No.6 • Published, under license, by Globetech Media LLC Copyright © 2020. All rights reserved. Rep­ro­duction in any form is forbidden without express permission.

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drugs for the treatment of COVID-19. Aerogen is collaborating with pharmaceutical companies in multiple COVID-19 drug development initiatives, including the development of new inhaled drugs that will ultimately play in the COVID-19 response.

Aerogen is working with pharmaceutical companies worldwide to ensure safe delivery of inhaled therapies for COVID-19.

Portable, Non-Invasive Respiratory Monitor Detects COVID-19 in At-Risk Elderly Population The use of a portable, non-invasive respiratory monitoring system from MediPines (Yorba Linda, CA, USA; www.medipines.com) that detects pulmonary gas exchange impairment is proving valuable in monitoring the elderly and those who are at a high-risk of contracting respiratory illnesses like COVID-19. The AGM100 portable, non-invasive respiratory monitoring system provides rapid non-invasive pulmonary gas exchange measurements, typically in less than two minutes. The advanced respiratory monitoring system provides a comprehensive respiratory assessment designed to support medical providers with rapid detection of respiratory impairment. The AGM100 has been clinically validated and is FDA cleared and authorized for COVID-19 emergency use by Health Canada.

New AI-Based Tool Rapidly and Automatically Determines Which COVID-19 Patients May Need Hospitalization A new artificial intelligence (AI)-based score considers multiple factors to predict the prognosis of individual patients with COVID-19 seen at urgent care clinics or emergency departments. The tool, which was created by investigators at Massachusetts General Hospital (MGH Boston, MA, USA; www.massgeneral.org), can be used to rapidly and automatically determine which patients are most likely to develop complications and need to be hospitalized.

tered together are authorized for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

AI Algorithm Combines CT Images with Non-Imaging Data to Accurately Predict COVID-19 Patient Outcomes A team of engineers at the Rensselaer Polytechnic Institute (Troy, NY, USA; www.rpi.edu) has demonstrated how a new algorithm they developed was able to successfully predict whether or not a COVID-19 patient would need ICU intervention. The artificial intelligence-based approach could be a valuable tool in determining a proper course of treatment for individual patients.

GE Healthcare Launches First X-Ray AI Algorithm to Help Assess Endotracheal Tube Placement for COVID-19 Patients GE Healthcare (Chicago, IL, USA; www.gehealthcare.com) has launched a new artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements, a necessary and important step when ventilating critically ill COVID-19 patients. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.02, an industry-first collection of AI algorithms embedded on a mobile X-ray device for automated measurements, case prioritization and quality control.

New AI Platform Detects COVID-19 on Chest X-Rays with Accuracy and Speed A new artificial intelligence (AI) platform developed by researchers at the Northwestern University (Evanston, IL, USA; www.northwestern. edu) detects COVID-19 by analyzing X-ray images of the lungs and is

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NOVEMBER Eli Lilly’s Antibody Therapy Granted FDA EUA for Treatment of COVID-19 Eli Lilly and Company’s (Indianapolis, Ind, USA; www.lilly.com) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of recently diagnosed COVID-19. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Eli Lilly and Incyte’s Baricitinib Receives FDA EUA for Treatment of Hospitalized COVID-19 Patients The US Food and Drug Administration has issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib is a JAK1/JAK2 inhibitor licensed to Eli Lilly and Company (Indianapolis, Ind, USA; www.lilly.com) from Incyte (Wilmington, DE, USA; www.incyte.com). Baricitinib is a janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.

Regeneron’s REGEN-COV2 Becomes First Antibody Cocktail for COVID-19 to Receive FDA EUA Regeneron Pharmaceuticals, Inc.’s (Tarrytown, NY, USA; www. regeneron.com) antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Casirivimab and imdevimab adminis-

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about 10 times faster as well as 1-6% more accurate than individual specialized radiologists.

Called DeepCOVID-XR, the machine-learning algorithm outperformed a team of specialized thoracic radiologists - spotting COVID-19 in X-rays about 10 times faster and 1-6% more accurately.

DECEMBER First-Ever Oral Antiviral Drug Completely Suppresses Transmission of SARS-CoV-2 Virus within 24 Hours

COVID-19 Update

Researchers at the Institute for Biomedical Sciences at Georgia State University (Atlanta, GA, USA; www.gsu.edu) have found that treatment of SARS-CoV-2 infection with a new antiviral drug, MK-4482/EIDD-2801 or Molnupiravir, completely suppresses virus transmission within 24 hours. Because the drug can be taken by mouth, treatment can be started early for a potentially three-fold benefit: inhibit patients’ progress to severe disease, shorten the infectious phase to ease the emotional and socioeconomic toll of prolonged patient isolation and rapidly silence local outbreaks.

CorVent Medical’s RESPOND-19 Ventilator Receives FDA EUA for Multiple Patient Use CorVent Medical (New York, NY, USA; www.corventmedical.com) has been issued

an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for primary critical care use of the company’s RESPOND-19 Ventilator. Establishing a new category of ventilators, RESPOND-19 is designed for rapid expansion of critical care ventilation capacity to allow hospitals to treat more patients suffering from acute respiratory distress syndrome (ARDS) during times of greatest need. COVID-19 has transformed the market and RESPOND-19 aims to address the immediate and growing need for flexible, critical care ventilator capacity.

Rapid Test Could Identify Which COVID-19 Patients Are Responding to Drug Treatments A new study by researchers at the Rabin Medical Center (Petah Tikva, Israel; www. hospitals.clalit.co.il) shows that a first-ofits-kind rapid test could identify which COVID-19 patients are responding to drug treatments and which patients are still deteriorating and need higher doses of medication. The researchers demonstrated that a15-minute blood test from MeMed Diagnostics (Haifa, Israel; www.me-med.com) for the protein interferon gamma induced protein 10 (IP-10) could help guide treatment with corticosteroids.

Digital Chest Drain Prevents Contamination

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by providing uninterrupted drainage in care settings, including those without access to central vacuum. Thopaz+ also provides continuous and objective monitoring of air leaks, fluid drainage, and pressure on a digital display, with trends over time. Detachable canisters with an integrated hydrophilic overflow and bacteria filter ensure safe and simple collection of fluids.

During the COVID-19 pandemic, chest drains were considered a potential source of crosscontamination via aerosol generated particles, contributing to safety concerns for patients and staff. Thopaz+ filters are proven to effectively block passage of aerosolized viral particles as small as 25 nm; in comparison, SARS-CoV-2 is about 125 nm in diameter, while other common hospital-acquired infection (HAI) pathogens, such as Staphylococcus aureus and Serratia marcescens, are approximately 500 nm in diameter.

“We understand the critical need for a solution like Thopaz+ that can help healthcare professionals provide safer cardiothoracic drainage and reduce cross contamination, as well as healthcareassociated infections, during the COVID-19 pandemic and beyond,” said Melissa Gonzales, RN, BSN, executive vice president of Medela Americas.

“With its intuitive, easy-to-use design and filtration capabilities, Thopaz+ was developed to meet the evolving needs of healthcare professionals and patients, and simplify use while improving health outcomes and reduce costs.”

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“Despite the pandemic crisis, we have to provide our cancer patients with the best postoperative care while protecting health care professionals and other patients,” said thoracic surgeon Andrea Bille, MD, of Guy’s Hospital (London, United Kingdom). “Thopaz digital drains facilitate early mobilization and recovery, but also minimize the risk of aerosolized generated particles, preventing the spread of the coronavirus.”

A chest drain is a tube inserted through the chest wall between the ribs and into the pleural cavity to allow drainage of air (pneumothorax), blood (haemothorax), fluid (pleural effusion), or pus (empyema) out of the chest.

Image: The Thopaz+ digital chest drainage and monitoring system (Photo courtesy of Medela) HospiMedica International December/2020-January/2021

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Upgradeable X-Ray System Helps Eliminate Obsolescence

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new X-ray System offers a flexible and scalable approach to digital imaging that increases workflow efficiency and reduces costs.

The Carestream (Rochester, NY, USA; www.carestream.com) DRXCompass X-ray system is an upgrade-friendly unit that mitigates technology obsolescence. A set of advanced features and options allow for easy positioning, decreasing set-up time and increasing throughput.

These include vertical auto-tracking and auto-centering, as well as optional auto long-length imaging, especially useful for patients who have trouble standing or young children who are unable to hold still for long periods. An optional tilting wall stand (-20/+90 degrees) supports a wide range of additional exams.

An intuitive, user-friendly graphical user interface reduces training time for technicians and allows for a secure, swipe-and-go login. An image preview display on the tube head allows technologists to remain with the patient during the exam, positioning the unit using color-coded buttons on the tube head handle that match colors on the overhead rails, so that they can know which button controls which movement.

With the aid of SmartGrid Image Processing, pristine image quality is available at a lower dose, without the use of a traditional grid. Integrated

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Optical MEG Sensor Detects Weak Brain Waves

n optical magnetoencephalography (MEG) sensor can help detect signs of traumatic brain injury (TBI), dementia, and schizophrenia, according to a new study.

Developed at the University of Birmingham (UB; United Kingdom; www.birmingham.ac.uk), the new sensor is based on an optically pumped magnetometer (OPM) that utilizes a nonlinear magneto-optical rotation (NMOR) technique, with polarized light used to detect changes in the orientation of atom spin when exposed to a magnetic field.

The sensor head, which contains only optical, non-ferrous elements, is connected to a module that holds all the electronic components located outside the magnetically shielded room to further reducing crosstalk.

Using the OPM sensor, the researchers were able to detect auditory evoked fields in a background field of 70 nT, suggesting it could be used for MEG testing outside of a specialized unit, or even in a hospital ward.

When it was benchmarked against conventional superconducting quantum interference device (SQUID) sensors, performance was comparable.

The researchers further demonstrated that the OPM sensor could detect brain oscillation modulations in the alpha band. The study was published on October 24, 2020, in NeuroImage.

“Existing MEG sensors need to be at a constant, cool temperature and this requires a bulky helium-cooling system, which means they have to be arranged in a rigid helmet that will not fit every head size and shape.

They also require a zero-magnetic field environment to pick up the brain signals,” said lead author Anna Kowalczyk, PhD. “Testing demonstrated that our stand-alone sensor does not require these conditions. Its performance surpasses existing sensors, and it can discriminate between background magnetic fields and brain activity.”

“We know that early diagnosis improves outcomes and this technology could provide the sensitivity to detect the earliest changes in brain activity in conditions like schizophrenia, dementia, and ADHD,” said study co-author Professor Ole Jensen, PhD, co-director of the UB Centre for Human Brain Health. “It also has immediate clinical relevance, and we are already working with clinicians at the Queen Elizabeth hospital to investigate its use in pinpointing the site of traumatic brain injuries.”

MEG systems have traditionally been based on very sensitive magnetometers cryogenic sensors which detect the small extracranial magnetic fields generated by synchronized current in neuronal assemblies. Newer non-cryogenic quantum-enabled sensors are based on OPMs. This allows for a millisecond-by-millisecond picture of which parts of the brain are engaged when different tasks are undertaken, such as speaking or moving.

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ImageView Software offers upgraded cybersecurity.

“The DRX-Compass is a system that can be configured to fit most facilities’ budgets and can grow with customers as their needs change, with minimal downtime,” said Steve Romocki, worldwide product line manager for radiology systems at Carestream. “A customer can choose the X-ray components that are ideal for their facility, now knowing the system can be easily enhanced to meet their future needs. This will offer our customers who are still using analog the opportunity to move to a new digital platform and it provides flexibility for what the future will bring.”

Image: The DRX-Compass X-ray system b(Photo courtesy of Carestream)

PRODUCT NEWS

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MOTORIZED TILTING TABLE

MOBILE X-RAY SYSTEM

CT SYSTEM

The TLX Classic+ motorized tilting table offers motorized tilting operation in all positions from +90° to -15° with movement and stops in horizontal position. An ideal choice for all routine fluoroscopic and radiological exams.

The Optima XR240amx is a pediatric-capable mobile X-ray system featuring high resolution 100 micron digital detectors and FlashPad HD that enable fine details to be seen with exceptional contrast.

The NeuViz 16 Essence is a 128-slice CT system that features a 32-row isometric detector design with 20mm coverage for fast scanning and high quality images. It features unique O-dose platform and advanced ClearView algorithm.

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GE Healthcare

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Neusoft Medical Systems

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CT in a Box Boosts Imaging Capability at COVID-19 Surge Hospitals

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prefabricated container that houses a computerized tomography (CT) system helps assess COVID-19 disease progression and complications, while also smoothing patient flow.

Located at Henri Mondor University Hospital (Créteil Cede, France; www.chu-mondor. aphp.fr), the “CT in a box”, developed by GE Healthcare (GE, Little Chalfont, United Kingdom; www.gehealthcare.com), is a 36 sqm transportable structure dedicated to COVID-19 patients. The concept was conceived following the rapid spread of the infection in France during March 2020, which motivated hospital authorities to nearly double the facility’s intensive care unit (ICU) capacity from 90 to 175 beds, requiring an additional CT unit. The Henri Mondor system hold a GE Healthcare Optima CT. The design consists of two small, prefabricated cabins that are joined into a single, square module, with a lead-lined, shielded

partition wall between the exam and control rooms. To replicate the controlled, easily accessible environment of a hospital CT room, the walls have no windows; instead, technicians in the control room observe the patient and perform the imaging process by monitoring webcam images. Each room has a separate door at opposite ends of the module, while a heating, ventilation, and air conditioning (HVAC) unit maintains temperature at around 22 degrees Celsius.

“While the scan itself can be completed in a matter of minutes, technicians can accommodate around one patient per hour, due

to the time needed to prep the patient and fully sanitize the exam room,” said François Meignan, the GE Healthcare project manager who designed the project. “But the new module is not just about boosting the number of scans, but smoothing patient flow across the entire hospital. That is because the module will relieve pressure on the facility’s three existing CT machines and because it is located near the hospital’s ICUs, where it treats its COVID-19 patients.”

“At the beginning of the outbreak, China’s clinicians in remote or pop-up hospitals quickly called for the precise images CT scans provide to help them spot complications earlier,” said Kieran Murphy, CEO of GE Healthcare.

“To address this need, our engineers quickly developed CT-in-a-box, an easy to install modular machine that captures the same robust imagery of traditionally installed CT scanners. Learning from our experience there, GE Healthcare teams in France developed a similar solution to address the urgent need for additional imaging capacity.”

Image: The “CT in a box” in the Henri-Mondor parking lot (Photo courtesy of GE Healthcare)

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Portable MRI Scanner Improves Access to Neuroimaging

Medical Imaging

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portable magnetic resonance imaging (MRI) scanner based on a compact, lightweight, permanent magnet could expand enable point-of-care (POC) diagnostics for neurological emergencies. Developed at Massachusetts General Hospital (MGH; Boston, USA; www.massgeneral.org) and Harvard Medical School (HMS; Boston, MA, USA; https://hms.harvard.edu), the prototype brain MRI system uses an array of neodymium (NdFeB) rare-earth magnets that generate a low (80 mT) magnetic field with a built-in readout gradient.

The configuration reduces reliance on high-power gradient drivers, lowers the overall requirements for power and cooling, and reduces acoustic noise. Imperfections in the encoding fields are mitigated with a generalized iterative image reconstruction technique.

A Halbach cylinder design creates a transverse field inside the magnet and zero field outside the magnet that results in a minimal stray field that requires neither cryogenics nor external power; the intrinsic self-shielding is thus ideal for portable applications where stray fields could pose safety hazards. The scanner can generate T1-weighted, T2-weighted, and proton density-weighted brain images with a spatial resolution of 2.2 × 1.3 × 6.8 mm3. The study was published on November 23, 2020, in Nature Biomedical Engineering.

“Although the scanner’s spatial resolution and sensitivity are both lower than that of a high-field MRI, its performance is sufficient to detect and characterize serious intracranial processes, such as hemorrhage, hydrocephalus, infarction, and mass lesions,” concluded lead author Clarissa Cooley, PhD, of the MGH department of radiology, and colleagues. “Our preliminary work also suggests that diffusion-weighted

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AI-Powered Platform Assists Radiologist Collaboration

imaging, which is critical to applications such as acute stroke detection, should also be possible.”

A neodymium rare-earth magnet is made from an alloy of neodymium, iron, and boron formed into a tetragonal crystalline structure that has a magnetic energy value about 18 times greater than ferrite magnets (by volume) and 12 times (by mass). The strength and magnetic field homogeneity of such neodymium magnets has led to their introduction in MRI scanners as an alternative to superconducting magnets.

Image: A low-cost, low-power brain MRI device could scan brains at the POC (Photo courtesy of MGH)

novel application with integrated artificial intelligence (AI) capability allows image access, review, annotation, and imaging from any mobile device.

The Braid Health (San Francisco, CA, USA; www.braid.health) mobile application is designed for speed, security, and collaboration among patients and medical professionals, who can view and share imaging studies as needed. By tapping the share button, users can compose an email with a secure link, through which images can be routed immediately and directly, without the need to burn CDs or making phone calls. The Braid application also improves the quality of diagnostic imaging interpretation by providing feedback on up to 90% of reviewed studies.

The Braid mobility solution can be layered on top of any existing picture archiving and communication systems (PACS) or imaging storage system, without requiring expensive legacy technology in order to add mobile diagnostics. The platform also delivers lossless digital imaging and communications in medicine (DICOM) images up to ten times faster than legacy solutions, and uses U.S. National Security Agency (NSA) approved cryptography to ensure protected health information is maintained confidential at all times.

“Today’s phones have four times as many transistors as a radiology workstation purchased only a couple of years ago, effective display resolutions exceed those of 6MP medical displays, even at typical viewing distances, and contrast ratios are 1,000 times greater,” said Kevin Quennesson, CEO and founder of Braid Health. “Our work on edgebased computing, along with GPU based DICOM GSDF calibration, has allowed us to unlock the potential of these devices, all without needing to install an app.”

“The Braid platform puts cutting-edge consumer technology directly into the pocket of providers and patients, fundamentally raising the bar on quality when it comes to patient care,” said Rajni Natesan, MD, MBA, chief medical officer of Braid Health. “Leveraging the Braid platform, providers have the ability to facilitate care in a timely and collaborative manner, while allowing patients to continue their care journey seamlessly across health systems and providers.”

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PRODUCT NEWS

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MOBILE X-RAY

CR SYSTEM

SLIT CAMERA

The ULTRA 200 PLUS mobile X-ray with 300mA/125kV HF generating power brings convenience and X-ray radiation power for various applications. The mobile X-ray features a complete free-stop tube arm making tube positioning easy.

The iCR3600M is a rugged, dependable, single-plate scanner designed for high resolution mammography and general CR that allows physicians to achieve amazing workflow at a much lower cost than comparable CR solutions.

The RaySafe Pro-Slit is a so-called slit camera for accurate measurement of the focal spot size according to IEC 60336:2005. Its smart design enables repeatability and accuracy.

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Immersive Entertainment System Eases MRI Scan Anxieties

The Resonance Technology (Northridge, CA, USA; wwwmrivideo. com) CinemaVision is a video screening system that is composed of a headset that delivers symphonic-quality audio sounds and a video eye-visor with twin widescreen displays that help eliminate the fear of claustrophobia during the dark and noisy MRI or functional MRI scan procedure. Users can play a Blu-Ray or DVD movie, stream digital

movies from a USB flash drive, connect to wireless Bluetooth device, or use a convenient AUX connection to hook up external audio/video media to the system controller.

The images produced are equivalent to a 62-inch screen viewed from a distance of less than two meters away. Features include a widescreen (16:9) or standard television (4:3) aspect ratio; a total resolution of 240,000 pixels for each of the displays; a 45 degrees horizontal field-of-view; a digital stereo headset with 30 dB noiseattenuating 40Hz-40 kHz range frequency response; a proprietary cordless laser link that transmits the audio-video signal from the console to the magnet room; and compatibility with 3T-rated field strength magnets.

“This device represents more than thirty years of development and state-of-the-art engineering,” said Mokhtar Ziarati, President and CEO of Resonance Technology. “We are confident this product will give you the tools you need for comforting the patient while undergoing MRI or fMRI scan procedures. To maintain being the leader in fMRI and MRI patient comfort systems in the MRI field, we strive to deliver what the customer needs along with impeccable customer service.”

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Deep Learning Aids in TB Detection via Smartphone

n artificial intelligence (AI) pattern recognition model can detect tuberculosis (TB) on phone-captured chest X-ray images. The TBShoNet neural network, developed by researchers at the Massachusetts Institute of Technology (MIT, Cambridge, MA, USA; www.mit.edu) and National Cheng Kung University (NCKU; Tainan, Taiwan; https://web.ncku.edu.tw), was first pretrained on a database containing 250,044 chest X-rays with 14 pulmonary labels, which did not include TB. The pre-trained model was then connected to an additional two-layer neural network trained on augmented chest X-ray images. It was then recalibrated for chest X-ray smartphone photographs by using simulation methods to augment the dataset.

Subsequently, 662 photographs of chest X-ray taken by five different phones (330 TB and 326 normal X-rays) were processed in order to test TBShoNet model performance. The results showed that sensitivity and specificity for TB classification were 81% and 84%, respectively. The study was presented at the Radiological Society of North America (RSNA) 106th Scientific Assembly and Annual Meeting, held online during November 2020.

“An early diagnosis of TB is crucial but challenging for resource-poor

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Tele-Ultrasound Device Allows Pregnant Women to Scan at Home

Medical Imaging

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handheld device enables pregnant women to perform ultrasound scans on themselves and receive feedback from a physician or sonographer.

The PulseNmore (Omer, Israel; www.pulsenmore.com) device docks with a smartphone and utilizes advanced navigation and artificial intelligence (AI) tools, as well as an app, to guide users through the scanning process. The high quality images can be shared with physicians or sonographers, who can review the scans remotely in real-time or off-line using telemedicine platforms. The device provides peace of mind, and can help reduce the number of prenatal office visits, especially useful during the COVID-19 pandemic.

The user’s smartphone provides the initial computational power, screen, and connectivity; the images are analyzed in the cloud. Clalit Health Services (Tel Aviv, Israel; www.clalit.co.il), Israel’s largest health maintenance organization (HMO) and the one of the largest public HMOs in the world, with 4.6 million insured members, is the first healthcare provider to purchase the device, signing a multi-year agreement to provide tens of thousands of its pregnant members with the device, which is designed for a cycle of 25-50 scans.

“We have successfully miniaturized the traditional ultrasound system to create a solution that is both affordable and accessible for expectant families,” said Elazar Sonnenschein, MD, founder and CEO of PulseNmore. “According to Clalit, pregnant women pay ‘false’ visits to the emergency room more than twice on average with concerns about their baby’s well-being. Our solution provides vital information to healthcare providers to determine if a baby is healthy, helping expectant mothers have peace of mind at home and avoid unnecessary visits to the ER.” “Clalit’s physicians reviewed more than 1,300 selfscans in our initial study with PulseNmore and clearly saw fetal heart activity, movement, and amniotic fluid in 95% of the scans,” said Leor Wolff, head of translational innovation and eHealth at Clalit Health Services. “We are confident that PulseNmore’s device will support our healthcare professionals during COVID-19 and beyond, while enhancing the pregnancy experience and satisfaction for our members.”

Deep Learning Aids in TB Detection via Smartphone

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countries. TBShoNet provides a method to develop an algorithm that can be deployed on phones to assist healthcare providers in areas where radiologists and high-resolution digital images are unavailable,” said lead author and study presenter Po-Chih Kuo, PhD, of MIT and NCKU. “We need to extend the opportunities around medical artificial intelligence to resource-limited settings.”

TB is an infectious disease caused by the bacteria Mycobacterium tuberculosis. The disease primarily affects the lungs, but it can also affect other organs. Typical symptoms include persistent coughing (in which a person can bring up blood), weight loss, night sweats, a fever, tiredness and fatigue, and loss of appetite. TB is one of the most deadliest diseases in the world, since the bacteria can easily spread from person to person through airborne particles, and extensively drug-resistant (XDR) totally resistant TB types are becoming increasingly more common.

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Image: The PulseNmore dockable ultrasound solution (Photo courtesy of PulseNmore)

PRODUCT NEWS

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PHOTOTHERAPY LAMP

PATIENT MONITOR

VENTILATOR

The Elios lamp has been designed to integrate intensive phototherapy and heating treatment of newborns who can be placed in beds, changing tables and neonatal treatment tables, with everything integrated for use.

The A8 modular patient monitor features a 17-inch large screen anti-glare color LCD display, with fullscreen touch button operation. It offers up to a dozen monitoring parameters a variety of input methods.

The FlexiMag is a fast response ventilator that provides the main features for ventilation in neonatal, pediatric and adult patients, offering the lowest total cost of ownership in its category.

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Machine Learning Aids Identification of Large Vessel Occlusions

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it on a set that consisted of 10% of these same exams, which were classified into three categories: no LVO (83.5%); chronic LVO (13.6%); and acute LVO (2.9%). The researchers also used 683 positive LVO studies as an independent test set.

Using CTA, it is possible to demonstrate the anatomy of the aortic arch, carotid, and cerebral arteries, stenosis/thrombus of carotid or cerebral arteries, and an impression of the functioning collateral network.

Lack of enhancement also provides an estimate of the cerebral blood flow reduction. The results of the study showed that the CNN had a 96% accuracy rate and a 5% false-positive rate for categorizing LVOs. The study was presented at the Radiological Society of North America (RSNA) 106th Scientific Assembly and Annual Meeting, held online during November 2020.

“Almost 800,000 people in the United States have a stroke each year, and about 10% of those are due to large-vessel occlusions. Time is brain, so getting patients treated sooner will help them retain more neurologic function,” said lead author and presenter Ian Pan, MD. “3D CNNs were effective in identifying series of interest and acute LVOs in CT angiography. At a five percent false-positive rate, over 40% of acute LVOs would be successfully identified without manual intervention.”

Advanced AI imaging analysis will enable first responders to bypass emergency departments and take patients directly to an endovascular catheterization laboratory, the operating room, a hospital stroke unit, or

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the neuro-intensive care unit to provide immediate treatment, including administration of tissue plasminogen activator (tPA) and the potent blood pressure drug nicardipine.

Image: AI can help rapidly identify arterial occlusions in the brain (Photo courtesy of iStock Photo)

Cellphone-Sized Device Monitors IV Infusions

portable electronic drop counter easily and accurately monitors the drip rate of gravity intravenous (IV) infusion sets.

The Shift Labs (Seattle, WA, USA; www.shiftlabs. com) and Hometa (Albany, NY, USA; www.hometa.com) DripAssist infusion rate monitor is designed to precisely monitor the rate of an infusion via gravity drip, displaying infusion rate in real time and monitoring changes within one percent of true.

After clipping DripAssist onto the gravity set, the drip rate is adjusted on the IV set, and the alarm is set; the 75dB alarm sounds when rate change exceeds +/-13%, or when fluid flow stops. The device runs on one AA battery for 360 hours, and clips on to almost any tubing set. No calibration or maintenance are required.

“Shift Labs developed DripAssist specifically to meet the needs of healthcare settings that benefit from simple and accessible technologies that don’t require maintenance or extensive training,”

said Beth Kolko, CEO and co-founder of Shift Labs. “DripAssist has been deployed in over 200 healthcare settings, from military field settings to outpatient settings throughout America. In the past year, the United States Air Force partnered with Shift Labs to use DripAssist to provide life-saving infusions to wounded soldiers in austere battlefield settings that lack equipment, power supply, and time.”

“We are extremely pleased to add this technology platform to our initial portfolio for IV infusion administration, since DripAssist connects the inherently lower pressure mechanism of gravity infusion with the accuracy of infusion pump flow rate monitoring,” said Jeff Hover, President and CEO of Hometa. “We are excited about working with Shift Labs on the development of future generations of the DripAssist technology that will increase flow rate control to the lower pressure IV administration and measurement accuracy features.”

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AI-Based Tool Assists Interventional Electrophysiology

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n artificial intelligence (AI) algorithm helps annotate 3D anatomical and electrical maps of the heart during atrial fibrillation (AF) or atrial tachycardia (AT) events.

The Volta Medical (Marseille, France; www.volta-medical.com) VX1 AI software mapping system is an intuitive, userfriendly platform with an innovative deep learning algorithm that analyzes a patient’s electrograms in order to locate heart regions harboring a specific abnormality called spatiotemporal dispersion, which is evident during AF or AT. The system works with two acquisition systems, the Boston Scientific (Natick, MA, USA; www. bostonscientific.com) LabSystem Pro, and the GE Healthcare (GE, Little Chalfont, United Kingdom; www.gehealthcare.com) MacLab CardioLab. A cable connects the selected data acquisition system with an Advantech PCI1713U analog-to-digital converter, which transmits the acquired information to a computer outside the sterile operating room area that hosts the VX1 AI software.

The software then analyzes the patient’s electrograms and cues operators in realtime to spatiotemporal dispersion events, as well as cycle length, estimated from electrograms recorded with the mapping and the coronary sinus catheters. The results of the analysis are graphically presented on the computer display.

“Our ultimate goal is to offer an alternative to a lifetime of medication that can have problematic side effects in some patients, while bringing a better quality of life to those who suffer from bothersome daily disease symptoms,” said Jérôme Kalifa, MD, co-founder of Volta Medical. “This is what is generating increasing enthusiasm around the potential of our solution, which is compatible with most multipolar catheters and technologies currently used in operating rooms or electrophysiology labs.”

“AF represents a major challenge in cardiology due to the complexities associated with identification, localization, and treatment of the pathological zones that cause and perpetuate this abnormal heart rhythm,” said Seth Goldbarg, MD, director of cardiac electrophysiology at Weill Cornell Medical College (Flushing, V

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Image: The VX1 AI software mapping system (Photo courtesy of Volta Medical)

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NY, USA). “We are excited to be part of the further studies taking place with this AI software, as the Volta system may provide a major step forward in the effective approach to ablation of persistent atrial fibrillation.”

AF occurs when the heart’s two upper chambers beat erratically. In one form, paroxysmal AF, patients have bouts of erratic beats that begin spontaneously and usually last less than a week. AAD can control the heart rhythm and symptoms of AF, but many patients do not respond well. AF can lead to serious adverse events such as thrombi travelling from the heart to obstruct arteries supplying the brain, causing stroke, or other parts of the body causing tissue damage.

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PATIENT MONITOR

VITAL SIGNS MONITOR

VENTILATOR

The Classic-90PRO patient monitor is provides functions such as continuous monitoring, real-time recording and display of vital physiological parameters, including SpO2, PR and NIBP.

The VitaGuard VG 3100 monitors oxygen saturation (SpO2), heart rate and respiration of risk patients of all ages, giving medical personnel and caregivers the security they need, both in ambulatory and clinical environments.

The Philips Trilogy EV300 hospital ventilator delivers enhanced performance in noninvasive (NIV) and invasive (IV) ventilation, so patients can be treated with a single device throughout their hospital stay.

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Lower Ventilation Pressure Sufficient for Healthy Lungs

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lower PEEP strategy (0-5 cm H2O) was noninferior to a higher PEEP strategy (8 cm H2O). All patients were without ARDS, and were not expected to be extubated within 24 hours of ventilation initiation. The primary outcome was the number of ventilator-free days at day 28.

The results showed that at day 28, patients in the lower PEEP group had a median of 18 ventilator-free days, while those in the higher PEEP group had a median of 17 ventilatorfree days. Mortality was 38.4% versus 42%, occurrence of severe hypoxemia was 20.6% versus 17.6%, and need for rescue strategy was 19.7% versus 14.6%, respectively. In addition, there were no major differences in duration of ventilation, ICU, or hospital lengths of stay, pulmonary complications, and the other secondary endpoints. The study was

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published on December 9, 2020, in JAMA. “There has been a gradual and noticeable increase in use of higher PEEP in patients without ARDS in ICUs worldwide,” concluded senior author Marcus Schultz, MD, PhD, of AMC, and colleagues. “It may not be better to use a lower PEEP strategy, but it could be as good as higher PEEP. These findings support the use of lower PEEP in patients without ARDS.” Ventilation with higher PEEP may lead to a better distribution of lung aeration, improving oxygenation, and could even prevent ARDS. However, it could also worsen existing or cause new lung injuries, since ventilation with higher PEEP impairs blood hemodynamics and increases the need for additional fluid administration or vasopressors. And because it is common practice to extubate at lower

PEEP, use of higher PEEP could also delay weaning in some settings. The study was concluded before the onset of the COVID-19 pandemic.

Image: Lower PEEP levels are as efficient as higher ones (Photo courtesy of Getty Images)

Low Dead Space Needles Assist Mass Vaccination

specially developed needle can potentially save a significant amount of a vial’s contents, which could help vaccinate millions more against COVID-19.

The TSK Laboratory (Vancouver, Canada; www.tsklab.com) low dead space needle reduces average dead space to 14 microliters, compared to a conventional needle, which has an average dead space of about 45 microliters. A conservative estimate shows that using the dead space needle could lead to a savings of 20 microliters per dose, while an optimistic one suggests 40 microliters can be saved. This represents a 4-8 percent saving, on the assumption that a typical vaccine dose is 0.5 milliliters. And by keeping the dead space as low as possible, the full indicated vaccine dose can be given with each injection.

The use of the dead space needle means less vaccine wasted, costs reduced, and the right dose of the vaccine injected. For example, the European Union (EU) purchased 200 million doses of the

COVID-19 vaccine from Pfizer (New York, NY, USA; www.pfizer.com) and others to vaccinate 100 million citizens. This means that an additional four to eight million people in Europe could be vaccinated, compared to if a standard needle is used. The same benefit can be gained from the hundreds of around 700 vaccine candidates in development targeting the coronavirus disease (COVID-19).

“There is currently much talk about the development of a vaccine against COVID-19, but there is very little being said about how the vaccine will be injected when it becomes available. This is especially critical when it relates to mass vaccination programs,” said Doris de Beer, managing director of TSK Laboratory Europe. “The COVID-19 crisis is unprecedented in modern history and it affects everyone. We the people, governments and companies should work together in fighting this crisis.”

Vaccines, as most other injectable drugs, need

to be packaged in sterile borosilicate glass vials that are impermeable to corrupting gases like oxygen, which even high-grade plastics cannot impede for more than a few minutes. In 2019, the global pharmaceutical industry purchased some 12 billion vials; COVID-19 vaccines, which most likely will have to be administered in two separate injections, will require many billions of additional vials.

Image: Low dead space needles can conserve vaccine use (Photo courtesy of TSK Laboratory) HospiMedica International December/2020-January/2021

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EHR Patient Photographs Reduce Order Entry Errors

Critical Care

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isplaying patient photographs in the electronic health record (EHR) reduces wrong-patient order entry (WPOE), according to a new study.

Researchers at Brigham and Women’s Hospital (BWH; Boston, AM, USA; www.brighamandwomens.org), NewYork-Presbyterian Hospital/ Columbia University Medical Center (NYP; New York, NY, USA; nyp. org), and other institutions conducted a study involving 71,851 emergency department (ED) patients (mean age, 49.2 years; 59.4% female, 76.7% non-Hispanic) to evaluate if displaying patient photographs in the banner of their EHR was associated with a decreased rate of WPOE errors. Patients were encouraged to have their photographs taken after informing them of the intended safety impact.

The results showed that the risk of WPOE errors was significantly lower when the patient’s photograph was displayed in the EHR (odds ratio of 0.72). After adjustment for potential confounders, the effect size remained essentially the same (odds ratio of 0.57). The risk of WPOE error was also significantly lower in patients with higher acuity levels, and among patients whose race was documented as White. The study was published on November 11, 2020, in JAMA Network Open.

“Displaying patient photographs in the EHR provides decision support functionality for enhancing patient identification and reducing WPOE errors, while being non-interruptive, with minimal risk of alert

Elastomeric Respirator Provides Alternative PPE Option

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next-generation air-purifying respirator (APR) designed without an exhalation valve provides COVID frontline workers with respiratory protection.

The MSA Safety (Cranberry Township, PA; www.MSASafe ty.com) Advantage 290 LS is an elastomeric half-mask respirator (EHMR) that covers a wearer’s nose and mouth, with twin intake valves that can accept N95 flexi-filters or P100 hard shell filters. The soft, pliable combination of rubber and plastic construction provides a customized, pressure-free fit that instantly conforms to facial characteristics. And as it does not include an exhalation valve, the Advantage 290 LS serves both as personal protective equipment (PPE) solution, and as a source control to ensure a sterile healthcare environment.

“There are many benefits of deploying a respiratory protection program that incorporates EHMRs, including cost-efficiency, reduced space requirements for PPE warehousing, and fewer concerns associated with PPE insecurities during a pandemic,” said Greg Martin, vice president of product strategy and development at MSA. “Our team went a step further and developed a respirator that has the potential to be an even more appealing option for healthcare systems everywhere, as they assess plans for the future and their own pandemic preparedness.”

Elastomeric respirators, such as EHMRs or full facepiece tight-fitting respirators, can be repeatedly used, cleaned, disinfected, stored, and re-used. But elastomeric respirators with exhalation valves should not be used in surgical settings, as the unfiltered air coming out of it may contaminate the surgical field. On the other hand, while in industrial settings filters are replaced when breathing resistance increases, in healthcare settings this is unlikely, as the filters seldom become loaded with heavy concentrations of dust.

Image: The Advantage 290 Respirator elastomeric half-mask respirator (photo courtesy of MSA Safety)

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fatigue,” concluded lead author Hojjat Salmasian, MD, PhD, of BWH, and colleagues. “The successful implementation of such a program in an emergency department setting involves a modest financial investment, and requires appropriate engagement of patients and staff.”

Although studies indicate that practitioners place more than 99.9% of all orders for the correct patient, the large number of orders placed each day means that even an error rate of less than 1 in 1,000 would still lead to about 600,000 WPOE orders placed in the United States alone every year. WPOE rates are about double in the ED, which is attributed to the crowded, fast-paced environment and to frequent staff multitasking.

Image: Displaying a patients photograph on the HER reduces errors (Photo courtesy of iStock images)

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ENDOSCOPY SYSTEM

NEBULIZER

ANESTHESIA MACHINE

The EVIS LUCERA ELITE endoscopy system is the complete solution for gastrointestinal endoscopy with ease-of-use functionality and stateof-the-art technologies focusing on advancing visualization, control and workflow.

The GN-1000 Nebulizer evaporates the medicine and introduces it into the respiratory system. The device evenly sprays microscopic particles with low noise levels. Simple elegant design allows easy fitting in confined spaces.

The AX-900 Anesthesia Machine provides four kinds of control ventilation modes, three kinds of SMV modes and two kinds of pressure support ventilation nodes, providing more professional ventilation modes.

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New Thrombectomy System Tackles Large Clots

composed of a fully recoverable foldable wire structure made of nitinol that is mounted on a metal stem. The diameter of the mesh and the radial force on the vessel wall are mechanically adjustable by the handle, allowing optimum adaptability without causing stress on the vessel wall. The nitinol mesh is radiopaque for perfect visibility inside the vessels.

The system includes the handle and integrated slider, which controls mesh expansion, a locking-screw that sets the wire mesh at the selected diameter, and proximal and distal marker for correct positioning of the mesh inside the vessel. Percutaneous delivery is via a standard microcatheter with an internal diameter of 0.021 in. At the end of the procedure, the mesh is removed, resulting in recanalization of the vessel.

Another advantage is that it is not necessary to continue long-term antiplatelet therapy, as required in the case of stent implantation.

“Tigertriever XL is another example of our powerful technology that adjusts to the vessel diameter for full clot removal in the treatment large vessel occlusion,” said

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Ronen Eckhouse, CEO of Rapid Medical (Yokneam, Israel; www.rapid-medical.com), “Tigertriever XL compliments Tigertriever 13, the smallest stentriever available today, and the only stentriever indicated for distal vessel occlusion. The Tigertriever portfolio now allows surgeons to treat ischemic stroke in the majority of vessels where it occurs.”

“Tigertriever XL is a very important addition to the ischemic stroke market. For the first time, we have a tool that can be adjusted to these dimensions and is dedicated to retrieve large clot loads,” said senior interventional neuroradiologist Sebastian Fischer, MD, of Bochum University Hospital (Germany), who was the first to use the device in Europe. “This is an important addition to our current tool set, since it can potentially reduce the number of passes required to remove large strokecausing clots, for example, in the internal carotid artery.”

Timely restoration of cerebral blood flow using reperfusion therapy is the most effective maneuver for salvaging ischemic brain tissue that is not already infarcted. For eligible patients with acute ischemic stroke, intravenous

alteplase is first-line therapy, provided that treatment is initiated within 4.5 hours of clearly defined symptom onset. Mechanical thrombectomy is indicated for patients with acute ischemic stroke due to a large artery occlusion in the anterior circulation who can be treated within 24 hours of the time last known to be well, regardless of whether they receive intravenous alteplase for the same ischemic stroke event.

Image: Clot removed with Tigertriever XL at Bochum University Hospital (Photo courtesy of Rapid Medical)

Cellphone-Sized Device Monitors IV Infusions

portable electronic drop counter easily and accurately monitors the drip rate of gravity intravenous (IV) infu-

sion sets.

The Shift Labs (Seattle, WA, USA; www. shiftlabs.com) and Hometa (Albany, NY, USA; www.hometa.com) DripAssist infusion rate monitor is designed to precisely monitor the rate of an infusion via gravity drip, displaying infusion rate in real time and monitoring changes within one percent of true. After clipping DripAssist onto the gravity set, the drip rate is adjusted on the IV set, and the alarm is set; the 75dB alarm sounds when rate change exceeds +/-13%, or when fluid flow stops. The

device runs on one AA battery for 360 hours, and clips on to almost any tubing set. No calibration or maintenance are required.

“Shift Labs developed DripAssist specifically to meet the needs of healthcare settings that benefit from simple and accessible technologies that don’t require maintenance or extensive training,” said Beth Kolko, CEO and co-founder of Shift Labs. “DripAssist has been deployed in over 200 healthcare settings, from military field settings to outpatient settings throughout America. In the past year, the United States Air Force partnered with Shift Labs to use DripAssist to provide life-saving infusions to wounded

soldiers in austere battlefield settings that lack equipment, power supply, and time.”

“We are extremely pleased to add this technology platform to our initial portfolio for IV infusion administration, since DripAssist connects the inherently lower pressure mechanism of gravity infusion with the accuracy of infusion pump flow rate monitoring,” said Jeff Hover, President and CEO of Hometa. “We are excited about working with Shift Labs on the development of future generations of the DripAssist technology that will increase flow rate control to the lower pressure IV administration and measurement accuracy features.”

HospiMedica International December/2020-January/2021

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Cooling Device Limits Esophageal Lesions During Heart Ablations

repurposed cooling device could minimize esophageal injury during radio frequency ablation for atrial fibrillation (AF).

The ensoETM, a product of Attune Medical (Chicago, IL, USA; www.attune-med ical.com) is a single-use silicone tube (similar to a standard orogastric tube) that is inserted into the esophagus to control patient temperature via a closed-loop system. The device is positioned at the core, close to the great vessels and the left atrium of the heart. Once in position, water circulates from an external heat exchange unit. The ensoETM is currently used for body-temperature control, either warming in the intensive care unit (ICU) after surgery or for burn victims, or for cooling after head trauma, cerebral hypoxia, or in cases of high fever.

In a study conducted at St George’s University of London (SGUL; United Kingdom; www.sgul.ac.uk), 188 patients were assigned to esophageal placement of the ensoETM (protected group) or a temperature probe

(control group) prior to AF ablation. The results showed that mucosal injury occurred in 3.3% of protected patients and in 20% of control patients. Procedure duration averaged 186 minutes and varied between groups by less than one minute. At three months, there were no significant differences among groups in gastroparesis symptoms index or in gastroesophageal reflux disease (GERD) scores. The study was presented at the European Heart Rhythm Association Congress 2020.

“The device protected the esophagus significantly from mucosal injuries, so burns to the esophagus were significantly more common in the unprotected group,” said study presenter consultant cardiologist Mark Gallagher, MD. “Which patients would develop lesions was largely unpredictable, but there was a trend toward more lesions in patients who had a posterior wall line. Performance about that line did increase the risk of plexus injury and of mucosal injury, not surprisingly.

Other than that, we were not good at predicting who’s going to get a lesion.”

Autonomous Robot Performs COVID-19 Nasal Swab Tests

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new robotic system performs nasal swab tests on its own, helping to prevent cross infections among people being examined.

The Brain Navi Biotechnology (Hsinchu, Taiwan; www. brainnavi.com) Nasal Swab Robot (NSR) is designed to automatically, independently, recognize a patient’s facial structure and identify the nostril’s location, and subsequently take a sample of nasal secretions. The target population are suspected cases of whooping cough, diphtheria, influenza, and other types of diseases caused by the coronavirus family of viruses, including SARS, MERS, and COVID-19. The NSR is equipped with a compact robotic arm and display screen mounted on a wheeled trolley.

The procedure is based on three-dimensional imaging to identify facial and nasal characteristics, without the use of external frames, in order to move through nostrils, twirl the swab to collect a nasopharyngeal swab sample, remove it, and place it in a vial. With the aid of NSR, suspect patients can be tested safely around the clock, sparing medical health care workers the need to done personal protective equipment (PPE) and enter the high-risk environment during sample collecting. NSR could also allow autonomous specimen collection in airports, borders, drive-ins, or medical institutions.

“The SARS outbreak 17 years ago was a profound experience, but also left me deep wounds after losing a dear friend while we were saving lives. So, I decided to develop a robot to help save lives and be the first human to test NSR,” said Jerry Chen, MD, CEO of Brain Navi Biotechnology. “We feel the suffering of thousands of colleagues and patients worldwide with the pandemic. So, we developed the NSR in just eight weeks. We took some essential functions of our Autopilot Brain Surgical Navigation Robot.”

Testing for COVID-19 involves inserting a 15 centimeter long swab into the nasopharyngeal space, a cavity between the nose and mouth for 15 seconds, and rotating it several times.

The swabbing is then repeated on the other side of the nose to make sure enough material is collected. The swab is then inserted into a container and sent to a lab for testing.

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Critical Care

HospiMedica International December/2020-January/2021

Image: The ensoETM temperature control device (Photo courtesy of Attune Medical)

Esophageal injury during AF ablation accounts for about half of the mortality during the procedure, and is by far the largest cause of death. Previous strategies to protect the esophagus have been inadequate, including the use of proton pump inhibitors, to esophageal deflection, to infusing small amounts of cold water at a time into the esophagus. And esophageal temperature-monitoring probes could increase thermal injury and slow the procedure.

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NEONATAL INCUBATOR

VIDEO COLONOSCOPE

MEDICAL VIDEO RECORDER

The B8/B6 neonatal incubator provides a state- ofthe-art neonatal environment that promotes natural, peaceful healing, along with powerful functions, artistic external appearance and easy operation.

The CF-H290ECI diagnostic video colonoscope offers groundbreaking 520× magnification to enable direct observation of cells and nuclei, allowing for optical diagnosis of challenging lesions in the upper GI tract.

The AIDA medical video recorder offers the possibility to capture and store still images and video sequences in FULL HD, 4K and 3D quality and also offers the possibility to record two image sources simultaneously.

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Protective Device Maintains Colorectal Anastomosis Integrity

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n investigational temporary intraluminal bypass device could reduce the need for a diverting stoma in patients undergoing colorectal or coloanal surgery.

The Colospan (Kfar Saba, Israel; www.colo span.com) CG-100 Intraluminal Bypass Device is a silicone tubular sheath that is introduced into the colon through the anus using a designated delivery system. The protective sheath is held in place by a mechanism that consists of three inflatable balloons and an extra-luminal ring which encircles the colon, designed to prevent the silicone sheath from moving downstream from the anastomosis site.

By remaining in position without impinging, but still capable of moving freely inside the colon, the CG-100 can protect the anastomosis site from fecal material throughout the healing process, preventing it from damaging the colon wall. After approximately ten days, when the risk for leakage is reduced and

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anastomosis site integrity has been confirmed, the sheath and ring are removed under x-ray guidance, without the need for any further surgical intervention.

“There are limited options for patients who undergo a low resection of the colon,” said Craig Reickert, MD, head of colon and rectal surgery at Henry Ford Cancer Institute (Detroit, MI, USA). “Because the CG-100 device allows us to perform only a single minimally invasive procedure, the hope is that it can safely reduce the need for stoma and allow for a more comfortable and easy recovery, which increases the patient’s quality of life and allows them to avoid the complications that some encounter with a stoma.”

Most colorectal surgeries include the formation of an anastomosis, and one of the most dangerous complications related to the anastomosis is leakage, occurring in between

5 and 20% of patients. The diverting stoma is the standard of care used to reduce morbidity associated with anastomotic leaks, but it involves a high rate of complications associated with the stoma itself, along with patient discomfort, reduced quality of life, increased hospital stay, additional surgery, and increased medical costs. And in addition to its devastating impact on patients’ lives, almost 20% of the temporary diversions eventually become permanent.

Image: The CG-100 Intraluminal Bypass Device components (Photo courtesy of Colospan)

Radial Artery Occluder Ensures Patent Hemostasis

novel device helps prevent radial artery occlusion (RAO) following minimally invasive cardiac or vascular percutaneous procedures.

The Medical Ingenuities (Wheaton, IL, USA; www.medicalingenuities.com) PH Band is a universal radial artery compression device designed to achieve hemostasis after a transradial percutaneous procedure. Consisting of a wrist band with Velcro loop bands, a syringe, and two finger cots, it is used in conjunction with a flat micro Doppler ultrasound probe placed under a harnessing band with a built-in transparent window that allows visualization of the access site. The probe is aligned within the window immediately distal to the percutaneous access site.

The PH Band is designed not only to achieve viable hemostasis, but also allow the physician to confirm patency and antegrade blood flow distal to the access site compression bladder.

Use of the Doppler probe also helps guide the physician in applying the appropriate amount of pressure to achieve patent hemostasis and avoid over-compression and subsequent occlusion of the radial artery during wound closure.

“Worldwide, interventional cardiologists have been looking for a quick and simple way to achieve patent hemostasis in an effort to reduce complication rates and standardize patient recovery after accessing the radial artery,” said Chip Corrigan, founder and CEO of Medical Ingenuities. “The PH Band will provide the interventional cardiologist new and vital

information to properly complete a more effective radial artery closure. This outcome will, in turn, support their goal to reduce overall complications and healthcare costs, and in turn increase patient satisfaction.”

“The PH Band is uniquely poised to deliver on all fronts with the potential to methodically reduce occlusion rates, reduce bleeding, eliminate variability, and minimize valuable nursing resources,” said Paul Grunenwald, MD, of AMITA Alexian Brothers Medical Center (Elk Grove, Il, USA). “The PH Band system provides real time audible and visual feedback to clinicians, to assist them in achieving patent hemostasis. This feedback will confirm the proper application of pressure to attain hemostasis, while ensuring the patency of the radial artery.”

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Novel Hernia Mesh Reduces Post-Surgical Failures

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new hernia mesh with integrated extensions increases anchoring strength and prevents mesh fixation failure.

The Deep Blue Medical Advances (DBMA; Durham, NC, USA; www.deepbluemedical.com) T-Line Hernia Mesh is intended to reinforce soft tissues where weakness exists during the repair of ventral hernias, when performed via an open onlay approach. T-Line is manufactured by the knitting and heat pressing of medical grade polypropylene monofilament yarn, with additional continuous, seamless extensions arising directly from the mesh body. After knitting, needles are fixed onto the ends of the extensions to allow them to be sewn into the abdominal fascia.

The mesh extensions are intended reduce the stresses placed on the mesh, tissue, and suture interface, as they have 15 times more surface area than traditional sutures--similar to how snowshoes prevent sinking into snow--thus reducing fixation stress by spreading the force over a greater area. T-Line mesh extensions are designed to withstand significant abdominal pressures (up to 50 N/cm). This eliminates a key point of failure for conventional mesh fixation, whichoften leads to mesh migration, contraction, and eventual failure.

“In literature, long term hernia repair failure rates are 32% using conventional mesh and 63% using suture alone. Deep Blue’s products enhance hernia surgery with a potentially significant impact,” said Bill Perry, CEO of DBMA. “Furthermore, extensive lab and benchtop testing indicate that the T-Line Mesh has ~275% greater anchoring strength than standard of care in the perioperative period. This is always important, but particularly so in the period before significant tissue ingrowth into the mesh has occurred.”

Ventral hernias typically occur when the inner lining of the abdominal wall bulges through or causes in tears weakened abdominal wall muscles--often from previous surgery-- and forms a balloon-like sac.

This can allow a loop of intestines or other abdominal contents to push into the sac, potentially leading to serious problems that might require emergency surgery. Ventral hernias can also occur in the belly button (umbilicus) or any other area of the weakened abdominal wall.

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Endoscopic Ruler Measures Gastrointestinal Lesions

tiny ruler visible during an endoscopic examination allows for accurate gauging of a lesion or polyp’s size.

The Micro-Tech Endoscopy (Ann Arbor, MI, USA; www. mtendoscopy.com) Napoleon endoscopic measuring device is a tiny milimetric ruler designed to sit next to a lesion Image: The Napoleon Endoscopic in endoscopic view in order Measuring Device (Photo courtesy of to provide accurate gauging Micro-Tech Endoscopy) of lesion dimensions. Available in two different lengths, 15mm and 30mm, the Napoleon ruler is nestled inside the endoscope/colonoscope accessory channel until required, extending perpendicularly to the lens when fully deployed to provide an accurate measurement.

“The Napoleon device is the first of its kind to allow an accurate measurement of various features under endoscopic imaging,” said Chris Li, president of Micro-Tech Endoscopy. “It takes away the guess work and allows the physician to feel more comfortable with polyp size assessment and surveillance interval recommendations, especially during training.”

“The idea for the Napoleon came from the realization that there Cont’d on page 21

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Image: The T-Line Hernia Mesh (Photo courtesy of Deep Blue Medical Advances) RS TO LY IBUO APP R T T DIS TED I INV

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4K SURGICAL DISPLAY MONITOR

SUCTION PUMP

MOBILE C-ARM

The Eizo CuratOR EX3140, a 31.1-inch 4K surgical display monitor has a resolution of 3840 x 2160 pixels, four times the size of a full HD monitor. 4K UHD endoscope and microscope images can be reproduced in high definition.

The EuroVac H-90 electric, high-vacuum and highflow surgical suction pump is designed as suction devices for operation rooms where high-suction capability and rapid response is required.

The Cios Spin mobile 2D / 3D C-arm offers optimal 3D and 2D imaging for precise intraoperative guidance and versatility to advance therapy outcomes, providing more certainty in surgical routine and full control over procedures.

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Intelligent Respiratory Device Directly Oxygenates Blood

Cont’d from cover

allowing patients to remain awake and mobile during treatment, and preventing the need for medically induced comas and intubation. The AXT system, introduced by Inspira Technologies (Ra’anana, Israel; www.inspira-technologies.com), offers a broad range of patient oxygen level stabilization capabilities, as well as built-in selfinitiation technology that automatically adjusts its performance based on patient information and vital signs, thus eliminating the need for specialized technicians or medical staff.

The device frame is made of medical grade aluminum and magnesium and is five times smaller than invasive mechanical ventilators, making it highly durable, and allowing mobility, simplicity, and flexibility in numerous configurations and settings. An illuminated touchscreen interface displays three zones - the patient’s vital signs, system controls, and various data collected from the patient’s surroundings. A user-friendly operational dial is located below the

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screen. All disposable components are provided as a single “Plug & Play” combined set.

“Inspira’s AXT system is a fundamental game changer in the field of blood oxygenation,” said cardiac surgeon Yigal Kassif, MD, chairman of the Israeli extracorporeal membrane oxygenation (ECMO) Society, and chief advisor to Inspira Technologies. “This smart, affordable and simple to use system will make treatment more accessible and at a much earlier stage of treatment, far less invasive, much safer and more effective. My colleagues and I are more than excited to implement this new technology and provide better care to our patients.”

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

Image: The AXT system (Photo courtesy of Inspira Technologies)

Tiny Cardiac Implant Closes Congenital Heart Defects minimally invasive transcatheter implant the size of a pea closes patent ductus arteriosus (PDA) in premature

infants.

The Abbott (Abbott Park, IL, USA; www. abbott.com) Amplatzer Piccolo Occluder is a PDA closure device made of self-expanding, nickel-titanium wire single-layer mesh. The occluder is inserted percutaneously and guided into either the aortic or pulmonary artery via an anterograde (venous) approach, which is recommended in neonates weighing less than two kilograms, or via a retrograde (arterial) approach. The Amplatzer Piccolo is intended for infants weighing over 700 grams and more than three days old.

The tightly woven device closes the congenital shunt immediately after placement, and

subsequently integrates fully into the tissue, obviating the need for additional procedures related to the PDA. Features include intaglio wire treatment to reduce nickel leaching, extremely low-profile delivery that facilitates delivery in small vasculatures using a 4 F catheter, a symmetrical design that offers procedural flexibility, and predictable placement thanks to a disc size that facilitate positioning in the duct.

“The Piccolo Occluder greatly increases our ability to close PDAs in the tiniest, most medically fragile babies, offering better options for patients who need corrective treatment and are high risk to undergo heart surgery,” said pediatric interventional cardiologist Jeremy Ringewald, MD, of St. Joseph’s Children’s Hospital (Tampa, FL, USA). “Since the device is implanted through a minimally invasive pro-

cedure, many of the premature babies who are critically ill in the neonatal intensive care unit can be weaned from the breathing machine soon after the procedure.”

PDA is a congenital disorder in the heart wherein a neonate’s ductus arteriosus fails to close, remaining patent (open), thus allowing part of the oxygenated blood from the left heart to return to the lungs by flowing from the aorta to the pulmonary artery. Early symptoms are uncommon, but in the first year of life include increased work of breathing and poor weight gain. With age, the PDA may lead to congestive heart failure (CHF) if left uncorrected. Neonates without adverse symptoms may simply be monitored as outpatients, while symptomatic PDA can be treated with both surgical and non-surgical methods.

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Surgical Techniques

New Embolic Device Provides Targeted Treatment

novel interventional embolization device can devascularize tumors by durable, long-term occlusion of the blood vessels supplying it.

The Fluidx Medical Technology (Salt Lake City, UT, USA; www.fluidxmedical. com) GPX embolic device is an injectable, low viscosity, aqueous-based solution that solidifies into a durable embolic material upon delivery, without requiring polymerization or dimethyl-sulfoxide (DMSO) precipitation. It is packaged in a ready-touse syringe, requires less than one minute of preparation, and is delivered through standard off-the-shelf micro, small, and large catheters.

GPX is intended for minimally invasive super-selective embolization of tumors, internal bleeds, tumors, aneurysms, vascular malformations, uterine fibroids, varicose veins, and other uses. The non-cytotoxic particles are easy to visualize under fluoroscopic x-ray. An important element of GPX use is that it has been confirmed that it does not adhere to catheters, and thus cannot result in an accidental catheter entrapment that can be catastrophic for the patient. The GPX Embolic Device is currently intended for investigational use only.

“GPX is an advanced embolic technology that overcomes the challenges associated with other embolic devices,” said Libble Ginster, CEO of Fluidx Medical Technology. “GPX can be used effectively for distal penetration and occlusion of vessel networks, as well as proximal ‘one-anddone’ use in conjunction with coiling. We look forward to GPX’s use to help a variety of peripheral and neurovascular patients.”

“We are impressed with the GPX embolic,” said Andrew Holden, MD, director of interventional radiology at Auckland City Hospital (New Zealand). “We delivered GPX through a long, 150cm, 2.4F

microcatheter from the patient’s radial artery. GPX was easy to use, precise, and occluded the tumor well. We look forward to using GPX across a broad range of applications to improve patient care.”

Embolic devices include particles, coils, and liquids or glues. Particles are usually small polymer spheres injected thorough catheters which flow downstream with the blood flow and fill large spaces. Coils can create a plug to occlude flow, but lack precision, sometimes perforating the vessel, and often require numerous expensive deployments to occlude. Liquid embolics have advantages for certain procedures, but are associated with cytotoxicity, vascular inflammation, clumping, polymerization and precipitation.

Image: The GPX low viscosity, aqueous-based injectable embolic solution (Photo courtesy of Fluidx Medical Technology)

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Endoscopic Ruler Measures Gastrointestinal Lesions

cont’d from page 19

is no way to accurately measure polyp size during colonoscopy, and surveillance guidelines are based on polyp size and number,” said Mark Pochapin MD, of NYU Langone Health (NY, USA) “Using the Napoleon may help us improve our ability to estimate polyp size and more accurately recommend post-polypectomy surveillance intervals.”

While small polyps seem to be harmless, larger polyps pose a greater threat, since cancer incidence is shown to increase with polyp size. About 91% of all advanced adenomas and 100% of cancer cases are from individuals with lesions of 10 mm or larger.

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­­ PRINT MAGAZINE • INTERACTIVE DIGITAL EDITION WEB PORTAL • MOBILE VERSION • MOBILE APPS E-NEWSLETTER • E-MAIL MARKETING ONLINE SOLUTIONS • SHOW DISTRIBUTION

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SUCTION DEVICE

EXAMINATION LUMINAIRE

SURGICAL MONITOR

The ACCUVAC Lite is a medical suction device for clearing the airway and features rugged housing and intelligent accommodation of the secretion canister and suction tube, able to evacuate vacuum splints and vacuum mattresses.

The HALUX N50 examination luminaire features a closed design for fast cleaning along with high-quality materials and durable LED technology, making it maintenance free. It offers a light output of 50 000 Lux @ 0.5 m.

The FM-D5801DV surgical monitor can show multiple screens at the same time on its large surface area, allowing the staff to view all critical operating room information at once on the large screen display monitor.

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Navigation System Advances Total Hip Arthroplasty

nnovative total hip arthroplasty (THA) technology helps maximize accuracy and reproducibility by delivering patient-specific component alignment.

The Smith & Nephew (London, United Kingdom; www.smith-nephew. com) RI.HIP NAVIGATION system is designed to empower surgeons by providing assessment of individual patient pelvic tilt, a predicted view of the post-op AP X-ray in surgery to assist with cup placement, and a digital measurement of leg length and offset changes to achieve more consistent leg length restoration. And since it takes advantage of express workflows and image-free technology, it does not require computerized tomography (CT) scans. In addition, the small footprint integrates seamlessly with the operating room environment.

The cup can intuitively be placed supported by live values for anteversion and inclination angles, with implant sizing assistance, restoration of native joint center, and verification of full implant seating. The system is based on the Brainlab (Munich, Germany; www. brainlab.com) software-guided surgery for hip replacement, which includes a five-step-registration method, easy and fast registration in both supine and lateral patient positions, no repositioning required in lateral patient position, and pinless fixation at the femur. The Brainlab orthopedic joint reconstruction business was integrated into Smith+Nephew in 2019.

“The integration of the orthopaedic joint reconstruction business

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FSN Medical Technologies

Image: The RI.HIP NAVIGATION system aids hip replacement procedures (Photo courtesy of Smith & Nephew)

Radial Artery Occluder Ensures Patent Hemostasis

novel device helps prevent radial artery occlusion (RAO) following minimally invasive cardiac or vascular percutaneous procedures.

The Medical Ingenuities (Wheaton, IL, USA; www.medicalingenuities.com) PH Band is a universal radial artery compression device designed to achieve hemostasis after a transradial percutaneous procedure. Consisting of a wrist band with Velcro loop bands, a syringe, and two finger cots, it is used in conjunction with a flat micro Doppler ultrasound probe placed under a harnessing band with a built-in transparent window that allows visualization of the access site. The probe is aligned within the window immediately distal to the percutaneous access site.

The PH Band is designed not only to achieve viable hemostasis, but also allow the physician to confirm patency and antegrade blood flow distal to the access site compression bladder.

Use of the Doppler probe also helps guide the physician in applying the appropriate amount of pressure to achieve patent hemostasis and avoid over-compression and subsequent occlusion of the radial artery during wound closure.

“Worldwide, interventional cardiologists have been looking for a quick and simple way to achieve patent hemostasis in an effort to reduce complication rates and standardize patient recovery after accessing the radial artery,” said Chip Corrigan, founder and CEO of Medical Ingenuities. “The PH Band will provide the interventional cardiologist new and vital

information to properly complete a more effective radial artery closure. This outcome will, in turn, support their goal to reduce overall complications and healthcare costs, and in turn increase patient satisfaction.”

“The PH Band is uniquely poised to deliver on all fronts with the potential to methodically reduce occlusion rates, reduce bleeding, eliminate variability, and minimize valuable nursing resources,” said Paul Grunenwald, MD, of AMITA Alexian Brothers Medical Center (Elk Grove, IL, USA). “The PH Band system provides real time audible and visual feedback to clinicians, to assist them in achieving patent hemostasis. This feedback will confirm the proper application of pressure to attain hemostasis, while ensuring the patency of the radial artery.”

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Cast Immobilization Superior for Scaphoid Fractures

Surgical Techniques

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new study recommends initial cast immobilization for adults with small fractures of the scaphoid waist, followed by surgery in cases of nonunion.

Researchers at Leicester University Hospitals (United Kingdom; www.leicestershospitals.nhs.uk), the University of York (United Kingdom; www.york.ac.uk), and other institutions conducted a two-arm, randomized superiority trial that included 439 adults (mean age 33 years, 83% men) presenting at 31 31 hospitals in England and Wales with a radiographicly confirmed bicortical fracture of the scaphoid waist of two mm or less. Patients were randomized on a 1:1 basis to surgical fixation (219 patients) or to cast immobilization, followed by immediate fixation if non-union was confirmed (220 patients).

The results showed mean patient-rated wrist evaluation scores did not differ significantly at 52 weeks between the surgical (11.9) and cast immobilization group (14). More participants in the surgery group suffered potentially serious surgical complications (14%, compared to one percent), while cast-related complications occurred in fewer patients in the surgery group (two versus 18%). Medical complication rates were similar between the groups (two percent). The study was published on August 8, 2020, in The Lancet.

“Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management,” concluded lead author Professor Joseph Dias, MD, of Leicester University Hospitals, and colleagues. “Adult patients with scaphoid waist fractures displaced by two mm or less should have initial cast immobilization, and any suspected non-unions should be confirmed and immediately fixed with surgery.”

The scaphoid is one of eight small bones that make up the “carpal bones” of the wrist. It connects two rows of these bones - the proximal row (closer to the forearm) and the distal row (closer to the hand). This connection puts it at extra risk for injury, most commonly caused by a fall on an outstretched hand. Treatment of scaphoid fractures is guided by the location in the bone of the fracture (proximal, waist, or distal), displacement (or instability) of the fracture, and patient tolerance for cast immobilization.

Image: Casting should be the first option in Scaphoid fractures

Navigation System Advances Total Hip Arthroplasty

cont’d from page 22

has gone well, and we are delighted to now be able to offer customers an exciting upgrade path with more capabilities,” said Randy Kilburn, senior vice president of commercial marketing for orthopedics at Smith & Nephew. “We look forward to continuing to collaborate with Brainlab to expand access to these technologies as well as developing further orthopedic reconstruction applications and sports medicine as well.”

Hip arthroplasty is the standard approach for treatment of displaced femoral neck fractures in older patients, and is preferred over fracture fixation, due to the tenuous blood supply of the proximal femur. During the procedure, fixation of the femoral stem can be accomplished with cement or via bony growth into a porous-coated implant (uncemented). In elective THA, uncemented femoral components are currently favored by US orthopedic surgeons, whereas cemented stems are preferred by European orthopedists.

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SURGICAL NAVIGATION SYSTEM

SURGICAL LIGHT

SURGICAL HEADLAMP

The Navient Cranial is a simple, accurate and affordable surgical navigation system for cranial procedures featuring a sleek, compact and portable cart along with a large touch screen for natural interaction.

The LEDVISION 65 surgical light offers high illumination intensity for examinations and minor procedures with the illumination intensity adjustable in three levels through gesture control.

The Qubit Warm (PLT-80F) warm cordless LED surgical headlamp provides 80,000+ lux of pure homogenous light at 4500 degrees Kelvin for true tissue color rendition and reduced eye fatigue.

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Endovascular Mesh Treats Cerebral Vasospasm

n adjustable endovascular device facilitates mechanical dilation of intracranial vessels suffering from vaso-

spasm.

The Rapid Medical (Yokneam, Israel; www. rapid-medical.com) Comaneci adjustable remodeling mesh is a fully-visible wire stent, primarily intended for aneurysm, that is permanently affixed to the end of an internal core wire for delivery via an endovascular approach; once positioned, the wire is withdrawn distally, thus expanding the mesh, creating radial dilation of the contracted intracranial vessel. As the expansion is sequential, users can gradually increase the applied force while monitoring dilatation, thus lowering the risk of vessel injury.

Features include a non-occlusive design that maintains blood supply to the brain; stable positioning; high vessel compliance; microcatheter support; adjustable proprietary FlexiBraid technology to provide incremental shaping control; and 100% radiopaque

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KARL STORZ

wires that provide realtime feedback. Three sizes are available: Comaneci, with a length of 32 mm, for vessels with a diameter of 1.54.5 mm; Comaneci Petit, with a length of 24 mm, suitable for vessels with a diameter of 1.5-3.5 mm; and the Comaneci 17, with a length of 22 mm, suitable for vessels with a diameter of 0.5-3 mm.

“Data collected from our procedures in Europe suggest Comaneci’s safe and successful performance in the mechanical dilation of intracranial vasospastic vessels,” said Walid Haddad, MD, chief clinical officer of Rapid Medical. “Mechanical dilation was successful in almost all cases, and was typically accompanied by significant neurological improvement. I believe that this procedure can meaningfully improve patient outcomes of this severe disease.”

Cerebral vasospasm is a devastating complication of subarachnoid hemorrhage, a type of hemorrhagic stroke. The spasms cause a narrowing of brain blood vessels, reducing blood flow. This occurs in 70% of patients and leads to neurological deterioration in up to 30%. Balloon angioplasty has so far been the main therapy for symptomatic patients, but such balloons block blood flow to the already ischemic brain tissue and also carry a risk of vessel perforation.

Image: The Comaneci adjustable remodeling mesh stent (Photo courtesy of Rapid Medical)

3D-Printed Interbody Devices Mimic Natural Bone

ovel 3D-printed porous titanium implants have been meticulously engineered, down to the cellular unit level, to emulate human bone.

The Centinel Spine (West Chester, PA, USA; www.CentinelSpine.com) FLX technology platform interbody implants show an equivalent subsidence performance to that of polyetheretherketone (PEEK), contain a proprietary, interconnected FUSE-THRU titanium lattice with a structure and modulus of elasticity that are similar to natural bone, and provide an optimized mechanical, visual, and osteophillic environment that reduces stress shielding, enables fusion assessment, and supports bony in-growth, on-growth, and thru-growth.

The radiolucent FUSE-THRU sections are

designed to reduce to imaging artifacts and improve visibility as compared to solid titanium implants, thus enhancing intra-operative visualization and enabling superior post-operative fusion assessment. FLX is available as an option with Centinel Spine’s ACTILIF and STALIF interbody portfolios. The STALIF implants provide compressive fixation at the fusion site, pulling the vertebral bodies onto the implant and graft material to enhance opportunities for fusion, in line with Wolff’s Law of Bone Healing.

“FLX has the preferred combination of porosity, micro, and nano-structural characteristics, while maintaining strength and integrity through intentional design,” said Steve Murray, CEO of Centinel Spine. “The technology is

backed by science; a cellular study conducted at the Hospital for Special Surgery in New York demonstrates that FLX is collaborative with its environment and truly enhances bone integration.”

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 forming a solid piece. Fusion procedures 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.

HospiMedica International December/2020-January/2021

24

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Hologic Acquires Biopsy Localization Leader in Germany

ologic, Inc. (Marlborough, MA, USA) has completed the acquisition of SOMATEX Medical Technologies GmbH (Berlin, Germany), a leader in biopsy site markers and localization technologies, for approximately USD 64 million.

The transaction supports Hologic’s strategy to provide a comprehensive suite of innovative solutions across the continuum of breast health care.

SOMATEX specializes in the development and manufacturing of minimally invasive devices in the areas of tumor diagnostics, biopsy and interventional specialties, providing Hologic with additional expertise and capabilities to continue to grow its breast health portfolio. The SOMATEX product portfolio includes the Tumark family of tissue markers, which were distributed by Hologic in the US prior to the acquisition.

Specifically, SOMATEX’s differentiated products will enable Hologic to strengthen and further expand its breast marker portfolio, which has been growing consistently. As a result of the acquisition, Hologic will also enhance its sales presence in Europe by expanding its direct channel in Germany and its network of regional and international dis-

T

tributor partners.

“The acquisition of SOMATEX allows us to expand our biopsy portfolio by providing a suite of market-leading solutions that not only address our customers’ needs, but also improve the biopsy experience for their patients,” said Jennifer Meade, Hologic’s Division President, Breast and Skeletal Health Solutions. “We’ve had a strong partnership with SOMATEX for several years, which along with our shared focus on innovation, will allow us to quickly integrate and begin building a pipeline that will drive profitable growth and recurring revenue for our breast health business globally.”

“For years, SOMATEX has been committed to driving innovative, best-in-class tumor marker and localization solutions for our customers and their patients and to becoming a leader in our space,” said Joerg Heise, Managing Director of SOMATEX. “We are excited to continue this journey through Hologic and their global footprint, providing so many more with access to these pioneering technologies that aid in the early detection and treatment of breast cancer.”

COVID -19 Pandemic Driving Expansion in Global Ventilator Market

he global ventilator market was valued at USD 11.4 billion in 2019 and has witnessed a growth surge of up to 172% in 2020 as an exponential rise in respiratory infections due to the coronavirus pandemic.

In addition to the rising incidence of respiratory diseases, the market is also being driven by a high rate of premature births, increasing demand for critical care in the geriatric population, and government initiatives for boosting ventilator production. However, the absence of trained clinical staff will act as a major restraint for market growth. These are the latest findings of BIS Research (Fremont, CA, USA; www.bisresearch.com), a global B2B market intelligence and consulting company.

The global ventilator market is anticipated to normalize from 2022 and grow consistently at a CAGR of 15.13% during the forecast period 2021-2030. In 2019, the annual global demand for the ventilators was 82,500. However, the accelerated spread of COVID-19 and rising severity of the cases globally has propelled the global demand for ventilators by 5.6 times, up to 413,000, by the end of 2020. To cope with the rising demand for ventilators, regulatory bodies across different regions, such as the Food and Drug Administration (FDA), Health Canada, and Therapeutics Goods Administration (TGA), have taken unprecedented steps by approving several devices under the emergency use authorization (EUA) provision. For instance, in March 2020, the FDA declared COVID-19 pandemic as a public emergency and authorized anesthesia gas machines, continuous positive airway pressure (CPAP), and other sleep apnea devices as alternative ventilators under EUA. Furthermore, in April 2020, the TGA published a document stating the minimum requirements to be met by medical devices to be used as alternative ventilators. Moreover, the regulatory bodies are also revamping ventilator supply chains to limit the supply shortage constraints. For instance, the FDA has authorized the usage of alternative materials for making ventilator tubing. Furthermore, the FDA has also approved modifications to ventilator motor so that other suppliers can manufacture it.

25

Industry News

HospiMedica International December/2020-January/2021

The global ventilator market is being favored by the development of low-cost ventilator products and partnerships between healthcare and non-healthcare companies for scaling up the ventilator production.

Non-healthcare companies across different industry verticals have developed novel ventilator prototypes and are assisting healthcare companies in increasing ventilator production. The market has witnessed increased production from various healthcare companies. Furthermore, owing to the pandemic various start-ups have also emerged as key players. Furthermore, the market has the opportunity for expansion in portable ventilators and digital education and training segment.

The largest installed base of the ventilators is in the US which still has a requirement of an additional 85,000 ventilators to cope with the situation of the COVID-19 pandemic. Europe’s ventilator market is anticipated to witness significant growth owing to the rising incidence of COVID-19 cases and increase in manufacturing of ventilators.

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MARCH 2021 ECR 2021 – European Congress of Radiology. Mar 3-7; Virtual Venue; Web: www.myesr.org WCE 2021 – 14th World Congress on Endometriosis. Mar 6-10; Virtual Venue; Web: endometriosis. ca KIMES 2021 – Korea International Medical & Hospital Equipment Show. Mar 18-21; Seoul, Korea; Web: www.kimes.kr 13th SIOP ASIA 2021 – International Society of

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ISMRM 2021– 29th Annual Meeting of the International Society for Magnetic Resonance in Medicine. May 15-20; Vancouver, Canada Web: www.ismrm.org

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Hospitalar 2021. May 18-21; Sao Paulo, Brazil; Web: www.hospitalar.com

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EAPS 2021 – Congress of the European Academy of Paediatric Societies. Apr 22-25; Virtual Venue; Web: www.eapaediatrics.eu

KIHE 2021 – Kazakhstan International Healthcare Exhibition. May 19-21; Almaty, Kazakhstan; Web: kihe.kz

SAR 2021 – Annual Scientific Meeting of the Society of Abdominal Radiology. Mar 21-26; Virtual Venue; Web: www.abdominalradiology.org

ECTES 2021 – 21st Congress of the European Society for Trauma & Emergency Surgery (ESTES). Apr 25-30; Virtual Venue; Web: www.estesonline.org

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Paediatric Oncology. Mar 19-21; Mumbai, India; Web: www.siopasia2020.com CHINA MED 2021 – 32nd International Medical Instruments and Equipment Exhibition. March 1921; Beijing, China; Web: www.chinaexhibition.com

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ECCC Dubai 2021 – 16th Emirates Critical Care Conference. Apr 8-10; Dubai, UAE, Web: eccc-dubai.com

EuroCMR 2021 – 18th Annual Meeting on CMR of the European Association of Cardiovascular Imaging (EACVI). May 6-8; Virtual Venue; Web: www. escardio.org/Congresses-&-Events/EuroCMR

ECIO 2021 – European Conference on Interventional Oncology. Apr 10-14; Virtual Venue; Web: www.ecio.org

ISET 2021 – International Symposium on Endovascular Therapy. May 9-11; Hollywood, FL, USA. Web: www.iset.org

ISBI 2021 – International Symposium on Biomedical Imaging. Apr 13-16; Virtual Venue; Web: biomedicalimaging.org/2021 141st Annual Meeting of the American Surgical Association (ASA). Apr 15-17; Seattle, WA, USA; Web: meeting.americansurgical.org WCN 2021 – World Congress of the International Society of Nephrology (ISN). Apr 15-18; Virtual Venue; Web: www.theisn.org/wcn21

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REHACARE 2021 – International Trade Fair for Rehabilitation and Care. Oct 6-9; Dusseldorf, Germany; Web: www.rehacare.com ESMRMB 2021 – 38th Annual Meeting of the European Society for Magnetic Resonance in Medicine and Biology. Oct 7-9; Barcelona, Spain; Web: www. esmrmb.org ANESTHESIOLOGY 2021- Annual Meeting of the American Society of Anesthesiologists. Oct 9-13; San Diego, CA, USA; Web: www.asahq.org EuGMS Congress 2021 – 16th International Congress of the European Geriatric Medicine Society. Oct 1113; Athens, Greece; Web: www.eugms.org IPR 2021 – International Pediatric Radiology Congress. Oct 11-15; Rome, Italy; Web: ipr2021.org Medical Japan 2021 Tokyo– International Medical and Elderly Care Expo. Oct 13-15; Tokyo, Japan; Web: www.medical-jpn.jp ESGO 2021 – 22nd Congress of the European Society of Gynaecological Oncology. Oct 23-26; Prague, Czech Republic; Web: www.esgo.org/esgo2021 EANM 2021 – 34th Annual Congress of the European Association of Nuclear Medicine. Oct 23-27; Hamburg, Germany; Web: www.eanm.org

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