HospiMedica International June 2022

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WORLD’S CLINICAL NEWS LEADER ISSN 0898-7270 Vol.40 No.2 • 5-6/2022

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AI Software Can Cut PET Scan Time in Half

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ecent research in PET has focused on decreasing noise and increasing signal-to-noise ratios (SNR). Digital PET with silicon photomultipliers (SiPM) has led to improved timing, energy, spatial resolution, and effective time-of-flight (TOF) sensitivity.

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Smart Stent for Hemodynamic Monitoring Could Eliminate Need for Angiogram Imaging

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ascular diseases are the leading killers worldwide, accounting for nearly a third of all human deaths on the planet.

Continuous monitoring of hemodynamics – blood flow through the vascular system – can improve treatments and patient

outcomes. But deadly conditions like hypertension and atherosclerosis occur in long and twisting vascular system with arteries of varying diameter and curvature, and existing clinical devices are limited by their bulk, rigidity, and utility.

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Pulsed Field Ablation Offers Safer Alternative in Treatment of Atrial Fibrillation

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issue adhesive washout and detachment are major issues for medical practitioners and may prove fatal for patients, especially when the separation happens in vital organs like the lungs, liver and the heart. These organs – even when healthy – undergo frequent movement (contractions and relaxations) due to physiological needs, which cause additional strain on tissue adhesives.

n the mission-critical world of transplantation, where there is no margin for error, advanced technologies are required to support transplant teams. The historic method of preserving and transporting organs uses plastic bags, ice, and consumer ice coolers. These non-FDA regulated devices provide un-controlled, un-monitored cooling that pose a risk of cellular injury to the transported organs and can affect transplant patient outcomes.

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INSIDE

a surgical procedure, “seeing is a primary necessity, and Isonclearly” is also in endoscopy. Surgeons require

COVID-19 Update. . . . . 3

excellent skills as well as reliable surgical instruments for a successful procedure. Now, a new white light endoscopic imaging system uses advanced technology to ensure that the operation goes smoothly for surgeons, making it a surgical tool of utmost value.

News Update. . . . . . . . . . 5 Product News . . . . . . . . 6-8

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AI-Enabled Tool Predicts Heart Attacks by Measuring Coronary Plaque in CTA Images

laque buildup can cause arteries to narrow, which makes it difficult for blood to get to the heart, increasing the likelihood of a heart attack. A medical test called a coronary computed tomography angiography (CTA) takes 3D images of the heart and

Bio Glue Can Replace Sutures and Staples

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Endoscopic Imaging System Enhances Surgical Vision

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New Transport System for Heart Transplants

Image: Larry A. Chinitz, MD, performing the Pulsed Field Ablation (PFA) procedure in the OR (Photo courtesy of NYU Langone Staff)

See article on Page 12

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ith catheter ablation presenting risks of damaging surrounding tissues, pulsed field ablation (PFA) is emerging as a novel, non-thermal energy source that can offer a safer alternative to conventional therapies.

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arteries and can give doctors an estimate of how much a patient’s arteries have narrowed. Until now, however, there has not been a simple, automated and rapid way to measure the plaque visible in the CTA images.

Investigators have now created Cont’d on page 7

News Update. . . . . . . . . 11 Product News . . . . . . 10-14

News Update. . . . . . . . . 17 Product News . . . . . . 16-20

Industry News. . . . . . . . . . 21 International Calendar . . . 22

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COVID-19 Update

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s hospitals and healthcare institutions around the world rush to order large volumes of COVID-19 remedies, the hospital/medical devices industry continues its unprecedented expansion to meet exploding global demand. The report that follows provides a survey of news and advances from February 16, 2021 until April 30, 2022. For a recap of earlier developments, the reader is invited to refer to previous issues of HospiMedica or visit www.

HospiMedica.com.

AI-Based Analysis of Expiratory Chest CT Images of Post-COVID Patients Shows Evidence of Small Airways Disease A new study by clinicians at the University of Iowa (Iowa City, IA, USA; www.uiowa.edu) has found air trapping, indicative of small airways disease, in patients with lingering respiratory symptoms after COVID-19 infection. The study grew out of observations from clinicians that many patients with initial SARS-CoV-2 infection who were either hospitalized or treated in the ambulatory setting later showed signs of chronic lung disease such as shortness of breath and other respiratory symptoms.

ECG Can Pinpoint Hospitalized COVID-19 Patients at High Risk of Death A new study by researchers at the Tel Aviv Sourasky Medical Center (Tel Aviv, Israel; www. tasmc.org.il) that examined the association between QT prolongation and long-term mortality in patients hospitalized with COVID-19 found that ECG can pinpoint hospitalized COVID-19 patients at high risk of death who might need intensive management. The study, which also evaluated the relationship between prolonged QT interval and myocardial injury further revealed that a prolonged QT interval on the ECG was an independent risk factor for both myocardial injury and one-year mortality.

Ground-Breaking and Novel Assays to Help Assess Organ and Tissue Damage in Transplant and COVID-19 Patients Eurofins Viracor, LLC (Lees Summit, MO, USA; www.eurofins-viracor.com) has entered into an exclusive license agreement with Cornell University (Ithaca, NY, USA; www.cornell.edu) to commercialize several ground-breaking and novel assays aimed at transforming the clinical management of COVID-19 and transplant patients impacted from tissue damage and infections. The collaboration will expand access to blood and urine-based cell-free DNA detection methods that will provide healthcare practitioners with highly accurate, non-invasive tools to identify and monitor for infection, rejection, and severity of organ damage in transplant and COVID-19 patients.

Organ-On-A-Chip Platform Helps Devise Strategy to Treat Severe COVID-19 Complications Using their novel organ-on-a-chip platform, researchers at the University of Toronto (Ontario, Canada; www.utoronto.ca) have identified a molecule with the potential to combat cytokine storms, one of the most severe complications of COVID-19

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HospiMedica International May-June/2022

infections. The team leveraged their expertise in organ-on-a-chip technology to identify the molecule, a novel anti-inflammatory peptide called QHREDGS that does not act on the virus directly. Instead, it works to prevent cytokine storm, a potentially life-threatening immune reaction.

Soft X-Ray Tomography 3D Scans Show How Cells Respond To SARSCoV-2 Infection and Treatments Researchers from Berkeley Lab (Berkeley, CA, USA; www.lbl.gov) and Heidelberg University (Heidelberg, Germany; www.uni-heidelberg.de) have developed an extremely fast new 3D imaging method that can show how cells respond to SARS-CoV-2 infection and to possible treatments.

This was achieved by cranking up the speed of imaging infected cells using soft X-ray tomography (SXT), a microscopic imaging technique that can generate incredibly detailed, three-dimensional scans.

Image: Digital images of cells infected with SARS-CoV-2 created from soft X-ray tomography (Photo courtesy of Berkeley Lab)

Third Day in Hospital a ‘Tipping Point’ In Severity of COVID-19 Pneumonia There is an urgent need to identify biomarkers that are predictive of COVID-19 disease progression to help optimize treatment. New research Cont’d on page 4

COVID-19 Update Cont’d from page 3

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presented at ECCMID 2022 by researchers at the University of Southern California (Los Angeles, CA, USA; www.usc.edu) has identified the third day of hospitalization as a tipping point in the progression of disease among symptomatic patients admitted for COVID-19 pneumonia.

Urinary Proteome Analysis Predicts Transition from Moderate to Severe Disease in COVID-19 Progression Scientists at the National Center for Protein Sciences (Beijing, China; www.ncpsb.org.cn) have found that urine may provide a window for us to see what is happening inside the human body and predict the transition from moderate to severe disease in COVID-19 progression. The team identified 4,255 proteins from the urine, in which proteins with functions of immune and metabolism were among the most significantly altered after SARSCoV-2 infection.

Hemodynamic Monitoring Can Predict Mortality in Critically Ill Patients, Finds Baxter Study An observational study sponsored by Baxter International, Inc. (Deerfield, IL, USA; www.baxter. com) has found that monitoring stroke volume and cardiac output trends for patients with critical conditions may provide insight into cardiac function and help predict patient outcomes, including mortality.

10-Minute Sepsis Risk Test Demonstrates Potential to Rapidly Risk-Stratify Suspected COVID-19 Patients Data from a study shows that the 10-minute IntelliSep sepsis risk stratification test from Cytovale (San Francisco, CA, USA; www.cytovale. com) has the potential to provide useful prognostic information for patients with suspected infection and possible immune dysregulation that

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A GLOBETECH PUBLICATION

Marc Gueron Founder & Editorial Director

Image: 10-minute IntelliSep Sepsis Test (Photo courtesy of Cytovale)

can lead to life-threatening organ dysfunction.

The novel test designed to quantify the state of immune activation by measuring the biophysical properties of leukocytes from a routine blood sample in less than 10 minutes has the potential to rapidly risk-stratify patients independent of pathogen, according to the study.

Dan Gueron Publisher Sanjit Dutt News Editor Raymond Jacobson, PhD News Editor Jerry Slutzky, PhD News Editor

Carolyn Moody Regional Director Joffre Lores Regional Director Dr. Jutta Ciolek Regional Director Parker Xu Regional Director Katsuhiro Ishii Regional Director

AI Model for Monitoring COVID-19 Predicts Mortality within 30 Days of Admission Researchers at the Universitat Politècnica de València (UPV, Valencia, Spain; www.upv.es) have developed an AI model for the early prediction of mortality (within the first 30 days of admission to the emergency department), focusing principally on adults aged over 50. They have also developed a deep learning application that helps to predict severity in all age groups.

Sweat Sensor Detects Key Biomarkers That Provide Early Warning of COVID-19 and Flu

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A team of bioengineers at University of Texas at Dallas (Richardson, TX, USA; www.utdallas.edu) in collaboration with EnLiSense LLC (Allen, TX, USA; www.enlisense.com) has designed a wearable sensor that can detect two key biomarkers of infection in human sweat, a significant step toward making it possible for users to receive early warnings of infections such as COVID-19 and influenza.

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CT Scan Study Shows Evidence of Persistent Lung Damage Long After COVID-19 Pneumonia

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A new study by researchers at Innsbruck Medical University (Innsbruck, Austria; www.i-med. ac.at) has found that some people recovering from COVID-19 pneumonia have CT evidence of damage to their lungs that persists a full year after the onset of symptoms. The study underscores radiology’s role in helping identify patients at risk for post-COVID-19 consequences and assisting in COVID-19 follow-up management.

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Endoscopic Imaging System Enhances Surgical Vision

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The OptoMedic 104K WhtNavi white light endoscopic imaging system from OptoMedic Technologies, Inc. (Guangdong, China; www. optomedic.com) is intended to be used with an endoscope, monitor, endo-intervention accessories, and other auxiliary equipment for real-time visible observation, diagnosis, treatment and image recording. Its 4K high resolution offers more accurate qualitative white light imaging without flickering or

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AI Predicts COVID Prognosis at Near-Expert Level Based Off CT Scans A new study by investigators at the Medical University of South Carolina (Charleston, SC, USA; www.web.musc.edu) to evaluate the ability of a chest CT deep learning algorithm for quantification of COVID-19 lung disease found that it was highly predictive of inpatient outcomes and performed at a near expert level. The study evaluated the ability of a deep convolutional neural network (dCNN) to predict inpatient outcomes associated with COVID-19 pneumonia also found that the tested dCNN could provide added value for clinicians in terms of prognostication and disease severity.

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delay. Its patented intelligent dimming technology prevents biological thermal burns.

The OptoMedic 104K WhtNavi white light endoscopic imaging system is in line with OptoMedic’s philosophy of “Innovating Technology, Keep Guarding on Life.” Some of the system’s applications include thoracic surgery, hepatobiliary surgery, stomach enterochirurgia, gynecology and urinary surgery, among others.

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Vol.40 No.2 • Published, under license, by Globetech Media LLC Copyright © 2022. All rights reserved. Rep­ro­duction in any form is forbidden without express permission.

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HospiMedica International May-June/2022

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MRI Shown Superior to ECG for Diagnosing Heart Failure

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ntil now, the best way of diagnosing heart failure has been an invasive assessment, but it carries risks for patients. Non-invasive echocardiogram, which is based on ultrasound, are usually used instead, but they are wrong in up to 50% of cases. Now, a new study has shown how magnetic resonance imaging (MRI) is superior to Echocardiography for diagnosing heart failure, as well as being a powerful tool to predict patient outcomes, including death.

Using MRI scans to detect heart failure could revolutionize how the condition is diagnosed, thanks to new research from the research from the University of East Anglia (Norfolk, UK; www.uea.ac.uk) and the University of Sheffield (Sheffield, UK; www.sheffield.ac.uk). The research team studied 835 patients who received an invasive assessment and a heart MRI on the same day from the ASPIRE registry - a database of patients assessed at the Sheffield Pulmonary Vascular Disease Unit.

“We showed that heart MRI is superior to Echocardiography in predicting pressure inside the heart. Almost 71% of patients who had wrongly measured pressures by Echocardiography had correct pressures by heart MRI,” said lead researcher Dr. Pankaj Garg, from UEA’s Norwich Medical School. “These findings will reduce the need for invasive assessment. This is not only cost-effective but also reduces risks to patients, as a heart MRI scan is a completely non-invasive test.

We also showed that the results from heart MRIs were powerful tools to predict whether a patient would live or die.”

Image: Using MRI scans to detect heart failure could revolutionize diagnosis (Photo courtesy of Pexels)

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Ultra-Powerful 7T MRI Could Help Cure Parkinson’s

oth Parkinson’s disease and a related disorder, progressive supranuclear palsy (PSP), are progressive brain diseases that not only affect movement but also damage motivation and cognition. Patients with Parkinson’s disease and PSP are often treated with drugs such as L-DOPA, which compensate for the severe loss of dopamine. But, dopamine treatment does little for many of the non-motor symptoms. Now, ultra-powerful 7T MRI scanners could be used to help identify those patients with Parkinson’s disease and similar conditions most likely to benefit from new treatments for previously-untreatable symptoms.

To understand the causes of cognitive symptoms in Parkinson’s disease and PSP, researchers at the University of Cambridge (Cambridge, UK; www.cam.ac.uk) used a new ultra-high strength ‘7T’ MRI scanner to measure changes in the brains of people with Parkinson’s disease, PSP, or in good health. 7T refers to the strength of the magnetic field; most MRI scanners tend to be 3T or below. Since dopamine treatment does little for many of the non-motor symptoms, scientists have begun to turn their attention to noradrenaline, a chemical that plays a critical role in brain functions including attention and arousal, thinking and motivation.

A study last year examining brains donated to the Cambridge Brain Bank, found that some people with PSP had lost as much as 90% of the noradrenaline-producing locus coeruleus. It is thought that in PSP, damage to the locus coeruleus is caused by a build-up of the junk protein tau. When noradrenaline breaks down, it appears to trigger changes in the tau protein that lead to its build-up. This then damages the same cells that produce noradrenaline, leading to a vicious circle.

A similar situation may occur in Parkinson’s disease.

The research team wanted to know how this tiny region could be studied in patients who are still alive. Previous MRI scanners have not had the resolution to measure the region in living patients. While most scanners can show structures at the level of detail of a grain of rice, 7T scanners, which have ultra-strong magnetic fields, can provide resolution at the size of a grain of sand. The scanners allowed the Cont’d on page 6

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AI Software Can Cut PET Scan Time in Half Cont’d from cover

This has resulted in faster scanning with less injected activity. However, despite these advances, there is an ever-increasing demand for PET scans, which can contribute to significant delays in scheduling examinations and patient management. Deep learning (DL), a subdivision of artificial intelligence (AI), has many emerging applications in nuclear medicine. DL is able to increase PET resolution, decrease noise, and thus enhance image quality. It may allow for reducing injected activity, acquisition time, or a combination of both. Now, a new study that investigated whether AI-based denoising halves PET acquisition time in digital PET/CT has found that AI allows [18F]FDG PET duration in digital PET/CT to be halved, while restoring degraded ½-duration PET image quality.

The study by investigators at Baclesse Cancer Center (Caen, France; www.baclesse.fr) examined Subtle Medical, Inc.’s (Menlo Park, CA, USA; www.subtlemedical.com) SubtlePET post-reconstruction PET denoising software that has been approved by the Food and Drug Administration and validated by the European Commission for [18F]FDG PET. The algorithm is based on deep convolutional neural networks (DCNN), the most common DL architecture. SubtlePET uses multi-slice 2.5D encoder-decoder U-Net DCNN. It takes the pixel’s neighborhood into account to reduce noise and increase image quality. Using a residual learning approach that is optimized for quantitative (L1 norm) and structural similarity (SSIM), it has learned to separate and suppress noise components while preserving non-noise components.

The software applies denoising to improve the image quality of low count PET (positron emission tomography) scans acquired in up to 25% of the original scan time, enabling centers to expedite patient care and

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improve patient comfort during PET exams. SubtlePET is FDA-cleared for use with 18F-FDG and 18F-Amyloid tracers and is CE-marked for use with 18F-FDG, 18F-Amyloid, 18F-Fluciclovine, 18F-DOPA, 18F-Choline, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images, expanding coverage for Prostate (PSMA) and Neuroendocrine tumors. The vendor-neutral software is a virtual upgrade to any brand of PET or PET/CT machine that boosts scanner performance across the entire fleet.

In the latest study, researchers aimed to evaluate the feasibility of halving PET acquisition time in a routine clinical setting by using SubtlePET while preserving visual and semi-quantitative PET performances in digital TOF PET/CT. The prospective study showed good visual and semi-quantitative performances of AI-denoised half-count PET compared to original PET in a digital PET/CT. The researchers simulated a two-fold reduction in the PET acquisition time and then applied SubtlePET. All PET series were successfully denoised within two minutes in an automatic workflow using a common GPU card. This makes it compatible with routine clinical use.

Visually, global image quality scores were similar between PET90 and PET45AI but lower and clinically insufficient in half-count PET45 due to high noise. The researchers obtained a few discordances (2.3%) between original PET90 and denoised PET45AI in the absolute detection of 856 lesions. The study findings support the routine use of Subtle PET combined with a two-fold faster PET acquisition. According to the researchers, the benefit of decreasing PET duration, thus reducing waiting time for appointments and helping patients who experience discomfort, outweighs the minor decrease in performance.

Ultra-Powerful 7T MRI Could Help Cure Parkinson’s

team to examine the locus coeruleus of their subjects and confirm that the greater the level of damage to this region, the more severe their symptoms of apathy and the worse they performed at cognitive tests.

The findings offer the hope of new treatments for these symptoms. A number of drugs that boost noradrenaline have already been through clinical trials for other conditions and hence have been shown to be safe and well tolerated. The researchers are now leading a clinical trial to see if these drugs alleviate symptoms in PSP. “The locus coeruleus is a devil to see on a normal scanner. Even good hospital scanners just can’t see it very well,” said Professor James

Rowe from the Department of Clinical Neurosciences at the University of Cambridge, who led the study. “And if you can’t measure it, you can’t work out how two people differ: who’s got more, who’s got less?”

“The ultra-powerful 7T scanner may help us identify those patients who we think will benefit the most,” added Dr Rong Ye from the Department of Clinical Neurosciences at the University of Cambridge, the study’s joint first author. “This will be important for the success of the clinical trial, and, if the drugs are effective, will mean we know which patients to give the treatment to.”

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Medical Imaging

3D Ultrasound Enables Real Time Observation of Blood Flow

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rgans are supplied by a complex network of blood vessels, which are essential for their proper functioning. Some imaging techniques give a global view of this vascular network, but for the first time, ultrafast 3D imaging allows us to observe blood flow from the large arteries to the smallest blood vessels of only a few micrometers in diameter.

Two successive studies by researchers at the Physics for Medicine Paris (ESPCI, Paris, France; www.espci.fr) have highlighted advances in non-invasive 3D ultrasound imaging, making it possible to observe blood flow in real time in two whole organs: the heart and the brain.

Over the last 10 years, ESPCI has made major advances in vascular imaging, with the development of ultrasensitive Doppler imaging (uDoppler) and then ultrasound localization microscopy (ULM) in 2D. This time, the researchers at ESPCI have reached a major milestone by deploying ULM in 3D: thanks to the three-dimensional aspect, the researchers obtained super-resolved images of the rodent heart and brain, at the scale of the entire organ. In addition to providing fundamental knowledge of organ function, this technique could also provide valuable information on various cardiovascular pathologies and even measure the effectiveness of different treatments.

To achieve such a feat at such fine resolutions, the scientists injected microscopic gas bubbles, the position of which was monitored at high imaging rates. This made it possible to obtain detailed information on blood flow and channel size, and thus to reconstruct the entire vascular activity of the organ. The team also had to overcome several techno-

logical challenges. For the heart, for example, it was necessary to find the ideal measurement window to be able to correct the movements linked to breathing and heartbeats on the image. For the brain, it may be necessary to implement post-processing algorithms to correct signal distortions induced by the skull. Moreover, the transition from 2D to 3D imaging implies a huge increase in the volume of data collected: for one minute of acquisition, the volume of data to be processed exceeds one terabyte of information. Before considering a move into the human clinic, the scientists will further improve their technology by optimizing the sensors, electronics and data processing methods.

Image: A major advance in 3D allows doctors to observe entire organs (Photo courtesy of ESPCI Paris)

AI-Enabled Algorithm Predicts Heart Attacks

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an artificial intelligence (AI)-enabled tool that accurately predicts which patients would experience a heart attack in five years based on the amount and composition of plaque in arteries that supply blood to the heart.

In order to develop the AI-enabled tool, investigators from Cedars-Sinai (Los Angeles, CA, USA; www.cedars-sinai.org) analyzed CTA images from 1,196 people who underwent a coronary CTA at 11 sites in Australia, Germany, Japan, Scotland and the US. The investigators trained the AI algorithm to measure plaque by having it learn from coronary CTA images, from 921 people, that already had been analyzed by trained doctors.

The algorithm works by first outlining the coronary arteries in 3D images, then identifying the blood and plaque deposits within the coronary arteries. Investigators found the tool’s measurements corresponded with plaque amounts seen in coronary CTAs. They also matched results with images taken by two invasive tests considered to be highly accurate in assessing coronary artery plaque and narrowing: intravascular ultrasound and catheter-based coronary angiography.

Finally, the investigators discovered that measurements made by the AI algorithm from CTA images accurately predicted heart attack risk within five years for 1,611 people who were part of a multicenter trial called the SCOT-HEART trial. The investigators are continuing to study how well their AI algorithm quantifies plaque deposits in patients who undergo coronary CTA. “Coronary plaque is often not measured because there is not a fully automated way to do it,” said Damini Dey, PhD, director of the quantitative image analysis lab in the Biomedical Imaging Research Institute at Cedars-Sinai and senior author of the study. “When it is measured, it takes an expert at least 25 to 30 minutes, but now we can use this program to quantify plaque from CTA images in five to six seconds.”

“More studies are needed, but it’s possible we may be able to predict if and how soon a person is likely to have a heart attack based on the amount and composition of the plaque imaged with this standard test,” said Dey, who is also professor of Biomedical Sciences at Cedars-Sinai.

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New Ultrasound Technology Offers Treatment Option for Aortic Stenosis

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ortic stenosis is a degenerative and potentially life-threatening condition, caused by calcium build-up which prevents the aortic valve from fully opening, leading to heart failure. The only current medical response is to replace the aortic valve with open heart surgery, or with a minimally invasive percutaneous valve (TAVI). Now, a new non-invasive treatment combining therapeutic ultrasound, robotics and ultrasound imaging brings great hope for patients with aortic stenosis and for their families.

Cardiawave SA (Paris, France; www.cardiawave.com) has developed VALVOSOFT, a revolutionary non-invasive medical device to treat aortic stenosis, the most prevalent heart valve disease in adults. VALVOSOFT is a breakthrough technology that allows for the remote application of an extremely precise and focused therapeutic ultrasound beam to restore valve function in patients with aortic stenosis. This intense beam decreases the stiffness of the aortic valve and improves its functional opening to allow sufficient oxygenated blood to reach the brain and the rest of the body.

Cardiawave has also announced the success of its First-In-Human I (FIH I) clinical trial to assess the safety, and operating system of the first generation of VALVOSOFT as well as the clinical effects of softening calcific aortic valve tissues with a beating heart. 30 patients (average age 84 years, with nine patients aged over 90 years) have been successfully treated. VALVOSOFT provided a sustained repair to the aortic vavlve for up to 12 months post treatment. The study has proven the safety and efficacy, as well as the ease of the procedure with a 60 minute non-invasive outpatient treatment. Following the successful VALVOSOFT treatment, two patients were able to have TAVI valve replacement.

VALVOSOFT non-invasive treatment offers the possibility of an efficient outpatient treatment for fragile patients, for whom valve replacement is too risky. In the longer term, treating patients with less severe stenosis would be a major step forward. A second feasibility and safety FIH II study is underway with 10 further patients. This includes brain

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MRI evaluation both before and after treatment to assess the risk of a stroke. Four patients were safely treated by the end of December 2021.

None of the MRIs detected an abnormality. Six further patients will be treated during H1 2022.

“The positive results of the safety and feasibility clinical studies we observed in our First In Human trial are extremely encouraging. We have shown that VALVOSOFT can treat patients who are exceedingly fragile and sick for whom no medical solution exists today. This represents a new treatment solution for aortic stenosis, over and above aortic valve replacement from which only a small minority of patients can benefit.

Cardiawave’s VALVOSOFT has the potential to become a standard new treatment for this deadly disease,” said Benjamin Bertrand, CEO of Cardiawave. “We are currently working on receiving the necessary authorizations in Europe for further clinical trials over the next few months.

I am confident that these will once again confirm the therapeutic benefits of VALVOSOFT.” Image: Patient affected by severe symptomatic aortic stenosis treated with Valvosoft (Photo courtesy of Amphia Ziekenhuis)

Obstetric Screening Technology Based on Deep Learning Simplifies Sonography Process

bstetric screening is the key to reducing maternal and perinatal mortality; however, conventional obstetric screening methods require high levels of medical expertise and are both time- and labor-intensive. Now, a new smart obstetric screening system based on artificial intelligence (AI) automates output of screening results through

automatic structure recognition, measurement, classification, and diagnosis to significantly enhance efficiency and reduce the workload of doctors.

SonoScape Medical Corp. (Shenzhen, China; www.sonoscape.com) has launched S-Fetus 4.0 Obstetric Screening Assistant, the world’s first smart obstetric screening technology based on deep learning that allows doctors Cont’d on page 9

HospiMedica International May-June/2022

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Medical Imaging

AI Accurately Predicts Who Will Develop Pancreatic Cancer Based on CT Scans

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ancreatic ductal adenocarcinoma is not only the most common type of pancreatic cancer, but is also the most deadly. Less than 10% of people diagnosed with the disease live more than five years after being diagnosed or starting treatment. But recent studies have reported that finding the cancer early can increase survival rates by as much as 50%. There currently is no easy way to find pancreatic cancer early, however. People with this type of cancer may experience symptoms such as general abdominal pain or unexplained weight loss, but these symptoms are often ignored or overlooked as signs of the cancer since they are common in many health conditions. Now, an artificial intelligence (AI) tool can accurately predict who would develop pancreatic cancer based on what their CT scan images looked like years prior to being diagnosed with the disease. The findings may help prevent death through early detection of pancreatic cancer which is one of the most challenging cancers to treat.

Investigators at Cedars-Sinai (Los Angeles ,CA, USA; www.cedars-sinai. org) reviewed electronic medical records to identify people who were diagnosed with the cancer within the last 15 years and who underwent CT scans six months to three years prior to their diagnosis. These CT images were considered normal at the time they were taken. The team identified 36 patients who met these criteria, the majority of whom had CT scans done in the ER because of abdominal pain. The AI tool was trained to analyze these pre-diagnostic CT images from people with pancreatic cancer and compare them with CT images from 36 people who didn’t develop the cancer. The investigators reported that the model was 86% accurate in identifying people who would eventually be found to have pancreatic cancer and those who would not develop the cancer.

The AI model picked up on variations on the surface of the pancreas between people with cancer and healthy controls. These textural differences could be the result of molecular changes that occur during the development of pancreatic cancer. The investigators are currently collecting data from thousands of patients at healthcare sites throughout the U.S. to continue to study the AI tool’s prediction capability.

“This AI tool was able to capture and quantify very subtle, early signs

of pancreatic ductal adenocarcinoma in CT scans years before occurrence of the disease. These are signs that the human eye would never be able to discern,” said Debiao Li, PhD, director of the Biomedical Imaging Research Institute, professor of Biomedical Sciences and Imaging at Cedars-Sinai, and senior and corresponding author of the study.

“There are no unique symptoms that can provide an early diagnosis for pancreatic ductal adenocarcinoma,” said Stephen J. Pandol, MD, director of Basic and Translational Pancreas Research and program director of the Gastroenterology Fellowship Program at Cedars-Sinai, and another author of the study. “This AI tool may eventually be used to detect early disease in people undergoing CT scans for abdominal pain or other issues.”

“Our hope is this tool could catch the cancer early enough to make it possible for more people to have their tumor completely removed through surgery,” said Touseef Ahmad Qureshi, PhD, a scientist at Cedars-Sinai and first author of the study.

Image: AI could detect pancreatic cancer from abdominal CT scans (Photo courtesy of Pexels)

Obstetric Screening Technology Based on Deep Learning Simplifies Sonography Process Cont’d from page 8

to automatically acquire standard planes and measure fetal biometry with fast performance and accuracy. Though 2D ultrasound is indispensable for the diagnosis of obstetric and gynecological diseases (especially in intrauterine fetal testing), conventional ultrasonography techniques rely heavily on the expertise of the sonographer. As time-consuming and skill-intensive manual operations are required throughout the entire process, ultrasonography poses challenges to hospitals in smaller communities and less-developed areas that have limited access to medical technology.

To address these issues, SonoScape’s smart diagnostic ultrasound solution based on AI technologies is capable of classification, detection, and segmentation of a variety of anatomical structures from ultrasound images through deep learning algorithms represented by convolutional neural networks (CNNs). Without the need for manually repetitive operation of the device, the system is designed with one-click simple touch to streamline the sonogram process and improve scanning efficiency. The S-Fetus 4.0 will run on SonoScape S60, P60, P60 Exp, S50 Elite, P50 Elite and P40 Elite, both in the North America and ROW region.

"Our obstetric screening assistant has achieved breakthroughs in terms of performance and scalability and now it can offer more efficient means of smart obstetric diagnosis that assist doctors in precise work to ensure better patient outcomes," said Zhou Guoyi, Head of SonoScape Medical Innovation Research Center.

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Unveiled: World's First Robotic Clinical Assistant for Hospital Patient Care

here are enormous pressures on nurses working in hospitals or nursing homes, especially due to the COVID-19 pandemics-related patient surge. A nurse traditionally monitors abnormal vitals and other critical abnormal data and is responsible for calling code and rapid response teams. While serving many patients, it is not possible to attend to multiple patients at the same time as any patient can have critical abnormal data at any time. Now, the world's first robot doctor aims to reduce this load on nurses and remain vigilant 24x7 even when nurses are taking care of other patients' needs, thereby minimizing human errors and prevent exhaustion or burnout among nurses.

Robot Doctor, LLC (Biloxi, MS, USA; www. ddxrx.com) has launched the world's first Ro-

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botic ClinicalAssist for hospitalized patient care.

The ClinicalAssist is a computer on wheel that can be placed in the patient’s room at the hospital and is connected to telemetry monitors and electronic medical records. The Robot will actively monitor for the availability of abnormal data and collect appropriate medical history that will help to determine the patient’s clinical condition. If appropriate, the ClinicalAssist will call a code blue or rapid response team. The device is built on artificial intelligence programs which are designed to reduce human errors and the workload of nurses.

Artificial intelligence programs are already incorporated into almost every sector of human life such as auto-driving cars and their adoption in healthcare is long overdue. ClinicalAssist is the

world's first Robot Doctor that was developed using a patented application that mimics the cognition of expert physicians. The Doctor Ai technology was used to develop Robot Doctor which was compared with human physicians to determine its efficacy in triage decision making.

The study found no significant differences in the decision-making capacity of Ai and human physicians related to finding the correct diagnosis and recommending correct treatment.

The company envisions that all hospitals will adopt the technology to reduce deaths among hospitalized patients, including those with symptoms of COVID-19. The technology could solve the global healthcare crisis in the near future and help increase access to healthcare for millions living in remote locations.

Triage Cardiac Panel Facilitates Rapid POC Diagnosis of Chest Pain Patients in ED

hest and abdominal pain are the most common reasons that persons aged 15 years and over visit the emergency department (ED). Because both emergency and non-emergency care are provided, symptoms vary widely in their acuity. The ECG is often non-diagnostic with a sensitivity of less than 60%. Atypical symptoms often seen in the elderly, women, and patients with diabetes make the clinical diagnosis even more difficult.

Prolonged laboratory results may delay recognition of critically ill patients and initiation of appropriate therapies. It has been shown that quicker treatment times are associated with improved patient outcomes due to an earlier diagnosis. A point-of-care (POC), serial multi-marker testing strategy has been shown to facilitate the rapid diagnosis and management of chest pain patients in the ED. Quidel Corporation (San Diego ,CA, USA; www.quidel.com) has developed the Triage Cardiac Panel for use in the ED that is FDA cleared to aid in the diagnosis of myocardial infarction. The Quidel Triage Cardiac Panel is a

rapid, point of care fluorescence immunoassay used with the Quidel Triage MeterPro. The test is designed to determine the level of creatine kinase MB (CK-MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. This can be used as an aid in the diagnosis of myocardial infarction (injury).

At discharge, it is estimated that as many as 85% of chest pain patients do not have a cardiac diagnosis and myocardial infarction was missed in 2% - 8%. The Quidel Triage Cardiac Panel’s POC multi marker strategy provides meaningful diagnostic information to differentiate acute myocardial infarction (AMI) from other cardiac abnormalities. It has a near perfect NPV (99.9%) that allows for rapid rule out and the potential to decrease ED Length Of Stay (LOS) and turnaround time (TAT). It also has the potential to increase the number of stays less than 24 hours (decreases unnecessary admissions), thereby improving clinical, economic and operational outcomes.

The test uses plasma or whole blood samples in EDTA and has time to results of about 20

minutes.

A 2008 retrospective analysis from three HCA hospitals tested chest pain patients using the Quidel Triage Cardiac Panel at one to three hour intervals. Rule-in criteria were (1) any TnI above the AMI cutoff on any draw; (2) a 50% increase in myoglobin levels with any detectable TnI on the last draw; or (3) a 50% increase in myoglobin with a concomitant increase in CKMB. In the retrospective study, most patients were safely evaluated and dispositioned in three hours or less. In the same three-hour window, rule-in patients were identified with a clinical sensitivity of 98.1%. Specificity was 98.1%; accuracy 99.7%; the PPV (positive predictive value) was 92.6%, and the NPV (negative predictive value) was 99.9%.

The study demonstrated a reduction of 60 patients (36%) coded as DRG 143 (non-specific chest pain), freeing up needed beds in the ED. The average length of stay for the ED was shortened by 122 minutes (31%). Moreover, NSTEMI patients were ruled in more quickly with a 41% reduction in their length of stay.

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Smart Pacifier Can Eliminate Invasive Blood Draws from Babies in the NICU

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abies in Newborn Intensive Care Units or NICUs have to bear twice-daily blood draws for monitoring of their electrolytes to help alert caregivers if the babies are dehydrated, which can be dangerous for infants, especially those born prematurely or with other health issues. The blood-draw method can be potentially painful for the infant, and it leaves big gaps in information since they are usually done once in the morning and once in the evening.

Other methods have been developed to test an infants’ saliva for these electrolytes, but they involve bulky, rigid devices that require a separate sample collection. Now, a wireless, bioelectronic pacifier could eliminate the need for invasive, twice-daily blood draws to monitor babies’ electrolytes in NICUs. The smart pacifier developed by researchers at the Washington State University (Pullman, WA, USA; www.wsu.edu) can also provide more continuous monitoring of sodium and potassium ion levels.

Using a common, commercially available pacifier, the researchers created a system that samples a baby’s saliva through microfluidic channels. Whenever the baby has the pacifier in their mouth, saliva is naturally attracted to these channels, so the device doesn’t require any kind of pumping system. The channels have small sensors inside that measure the sodium and potassium ion concenNE trations in the saliva. Then this data is DES W IGN relayed wirelessly using Bluetooth to the caregiver.

In a proof-of-concept study, the researchers tested the smart pacifier on a selection of infants in a hospital, and WORLD’S MEDICAL PRODUCT MARKETPLACE the results were comparable to data gained from their normal blood draws.

For the next step of development, SIGN UP the research team plans to make the FOR FREE! components more affordable and recyclable. Then, they will work to set up a larger test of the smart pacifier to establish its efficacy with the aim of making NICU treatment less disruptive for tiny patients.

“We know that premature babies have a better chance of survival if they get a high quality of care in the first month of birth,” said Jong-Hoon Kim, associate professor at the Washington State University School of Engineering and Computer Science and a co-corresponding author on the study. “Normally, in a hospital environment, they draw blood from the baby twice a day, so they just get two data points. This device is a non-invasive way to provide real-time monitoring of the electrolyte concentraConnecting Buyers with tion of babies.”

Suppliers Worldwide “You often see NICU pictures where Reach new sources of supply babies are hooked up to a bunch of Identify latest products and technologies Send inquiries directly to suppliers wires to check their health conditions Receive latest product alerts such as their heart rate, the respiratory Chat live with suppliers rate, body temperature, and blood pressure,” added Kim. “We want to get rid of those wires.”

Image: A wireless, bioelectronic pacifier could eliminate the need for invasive blood draws (Photo courtesy of WSU)

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AI Detects Cardiac Arrest Patients Who Can Benefit From Implantable Cardioverter Defibrillator Out-of-hospital sudden cardiac arrest claims at least 300,000 U.S. lives annually. For those affected, 90% will die within 10 minutes of cardiac arrest. For this largely fatal condition, prevention would have a profound impact. The biggest challenge, however, lies in distinguishing between those who stand to benefit the most from an implantable cardioverter defibrillator - and those who would not benefit from the electric jolt. Now, a clinical algorithm, for the first time, distinguishes between treatable sudden cardiac arrest and untreatable forms of the condition.

The findings by researchers in the Smidt Heart Institute at Cedars-Sinai (Los Angeles, CA, USA; www.cedars-sinai.org) have the potential to enhance prevention of sudden cardiac arrest -unexpected loss of heart function - based on key risk factors identified in this study. The new research provides a clinical risk assess-

ment algorithm that can better identify patients at highest risk of treatable sudden cardiac arrest - and thus, a better understanding of those patients who would benefit from a defibrillator.

The risk assessment algorithm consists of 13 clinical, electrocardiogram, and echocardiographic variables that could put a patient at higher risk of treatable sudden cardiac arrest.

The risk factors include diabetes, myocardial infarction, atrial fibrillation, stroke, heart failure, chronic obstructive pulmonary disease, seizure disorders, syncope - a temporary loss of consciousness caused by a fall in blood pressure - and four separate indicators found with an electrocardiogram test, including heart rate.

“This first-of-its-kind algorithm has the potential to improve the way we currently predict sudden cardiac arrest,” said Eduardo Marbán, MD, PhD, executive director of the Smidt Heart

Image: A new study has the potential to enhance prevention of sudden cardiac arrest (Photo courtesy of Cedars-Sinai)

Institute and the Mark S. Siegel Family Foundation Distinguished Professor. “If validated in clinical trials, we will be able to better identify high-risk patients and therefore, save lives.”

Pulsed Field Ablation Offers Breakthrough in Treatment of Atrial Fibrillation

Cont’d from cover

Catheter ablation has long been recognized as an effective treatment for a wide variety of cardiac arrhythmias, but the therapy runs a risk of damage to surrounding tissues. Now, pulsed field ablation (PFA) is emerging as a novel, non-thermal energy source that may offer a safer alternative to conventional catheter ablation technologies. PFA delivers ultrashort, high-voltage pulses to create lesions on targeted tissue.

This mechanism is also known as electroporation because it causes temporary pore-like openings in cell walls, leading to death by apoptosis. The frequency of the pulses can be adjusted to target specific proteins within cell membrane, leaving other types of tissue unharmed.

Previously used in oncology to destroy specific types of tumors or to increase tumor permeability to chemotherapy drugs, PFA has recently been adapted for catheter ablation by a number of

manufacturers. European regulators approved the first such device in January 2021, but the technology remains investigational in the U.S. NYU Langone (New York, NY, USA; www.nyulangone. org) is currently conducting clinical trials of three different PFA cardiac ablation devices in patients with atrial fibrillation.

Across the three trials testing devices developed by Medtronic, Farapulse, and Biosense Webster, primary outcomes include primary adverse events such as atrial-esophageal fistula and cardiac tamponade/perforation within seven days, and freedom from documented atrial arrhythmia, atrial tachycardia, or atrial flutter for up to one year. Secondary outcomes include the number of patients who achieve acute procedural success, defined as confirmation of entrance block in targeted atrial pulmonary veins after adenosine/isoproterenol challenge, and change

in quality of life after ablation.

PFA could replace radiofrequency and cryoablation as the premier energy source for cardiac ablation. Eventually, it could be adapted beyond atrial fibrillation to other arrhythmias, including those involving the ventricles. However, numerous questions about the new technology remain, including how durable are the lesions that PFA produces, the safety compared with conventional counterparts, and which of the available catheters is optimal for a given application, such as paroxysmal versus persistent atrial fibrillation.

“With traditional energy sources, we spend much of our time trying to avoid collateral damage to the nerves, blood vessels, lungs, or esophagus,” said Larry A. Chinitz, MD, director of the Heart Rhythm Center. “PFA offers the hope for an energy source that is instantaneous, efficacious, and specific to the heart.”

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Critical Care

Electrodiagnostic Monitoring of Brain Waves Predicts Impending Ischemic Stroke

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ubarachnoid hemorrhage is a type of stroke caused by bleeding into the space between the protective membranes surrounding the brain. This type of hemorrhagic stroke represents a neurological emergency, which is why patients with this type of stroke require immediate intensive care. When the brain’s normal blood supply is disrupted due to an acute blockage rather than a brain bleed, this is called an ischemic stroke. However, an ischemic stroke can also occur as the result of a subarachnoid hemorrhage. More than half of all patients who have had a severe subarachnoid hemorrhage will develop an ischemic stroke within the first two weeks after their brain bleed.

Researchers from Charité – Universitätsmedizin Berlin (Berlin, Germany; www.charite.de) have shown that massive electrochemical waves in the brain act as a marker announcing an impending ischemic stroke. Electrodiagnostic monitoring of these waves enables clinicians to identify the signs of an impending stroke early, particularly in comatose patients receiving intensive care following a subarachnoid hemorrhage. The findings could serve as the basis for the development of new treatments. Charité researchers have identified a biomarker which indicates that a patient is at high risk of an impending stroke post-subarachnoid hemorrhage.

The discovery was based on a phenomenon known as ‘spreading depolarizations’, massive waves of electrochemical energy release caused by the toxic by-products of blood breakdown following hemorrhagic stroke. Affected areas of the brain require large amounts of energy in order to restore normal conditions. In a healthy brain, very brief periods of depolarization (a change in the membrane potential) of nerve cells are normal and linked to blood supply: the brain can widen blood vessels as required, thereby balancing increased energy needs with an increase in blood flow. After a subarachnoid hemorrhage, however, pathologically massive and long-lasting spreading depolarizations can disrupt signaling cascades between nerve cells and blood vessels, so that the depolarization of nerve cells triggers extreme blood vessel constriction. This, in turn, deprives the nerve cells of energy, rendering them incapable of restoring normal electrochemical gradients. If depolarization persists for too long, these nerve cells will begin to die off.

This was the starting point of the current clinical study, which was conducted across five different university hospitals. In order to take accurate measurements of spreading depolarizations, the researchers employed electrocorticography, a procedure used to measure brain activity in neurological intensive care patients. To enable these types of measurements, patients admitted with subarachnoid hemorrhage had electrodes implanted under the dura mater (the brain’s tough outer membrane). The researchers also used imaging technologies such as magnetic resonance imaging (MRI) and computed tomography (CT), analyzing approximately 1,000 brain scans from 180 patients with subarachnoid hemorrhage. The largest clinical study on spreading depolarizations to date revealed that the average patient loses 46 milliliters of brain tissue during the early phase after their brain bleed, i.e., by the time they reach hospital.

The average patient then loses a further 36 milliliters of brain tissue during the first two weeks after their hemorrhage, i.e., while in intensive care.

This approach follows the principles of precision medicine, which aims to tailor treatments to the needs of the individual patient. The researchers plan to test spreading depolarization monitoring as an early warning system for use in routine clinical practice, where they hope it will help to improve treatment options for people with stroke.

Artificial intelligence-based methods are likely to play a major role in this regard. The automated analysis of electrodiagnostic data will be necessary to ensure intensive care physicians are notified in real time when an unconscious patient’s brain tissue is at risk of further damage.

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“It is difficult to judge when a new stroke might be developing, especially in patients who are in a coma and hence unable to tell us anything about their health status,” explained first author Prof. Dr. Jens Dreier of Charité’s Center for Stroke Research. “In our study, we have shown that electrodiagnostic monitoring makes this moment visible.

This means that treatment can be started in time, even in comatose patients, before it is too late.”

Image: Brain MRI images taken on days 2, 6 and 13 after a subarachnoid hemorrhage (Photo courtesy of Charité – Universitätsmedizin Berlin)

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Paper-Based Sensor Helps Bedside Therapeutic Drug Monitoring

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heophylline (THO) is effective in treating respiratory problems and inflammation, although the drug can be toxic if taken above certain limits. This demands accurate and rapid sensing devices that can closely monitor THO levels in patients. Scientists have now designed a paper-based THO sensor with a response time of three seconds. The sensor is not only easy to use but also economical and can reduce the burden of drug analysis in developing countries. Additionally, its prototype can be used to develop a bedside therapeutic drug monitoring system.

The highly selective and sensitive sensor was developed by a team of researchers from Shibaura Institute of Technology (Tokyo, Japan; www. shibaura-it.ac.jp) who also successfully tested it using whole bovine blood. THO is a natural organic compound whose molecular structure is very similar to that of caffeine present in coffee and cacao. Over the years, due to its therapeutic properties, THO has become one of the most widely studied xanthine group derivates. THO is used to dilate respiratory passages in people having difficulty breathing, and as a muscle relaxant, anti-asthmatic, and diuretic (drugs used to increase urine production and reduce blood pressure). It is also known to have anti-inflammatory and anti-tumor properties, and can regulate our immune responses too.

While THO is beneficial in treating a number of conditions, the drug has a very narrow therapeutic window. This means it can create adverse effects if administered beyond a certain limit (and that limit can be quite easily reached). An accidental or deliberate overdose can be highly toxic and lead to problems such as seizures, rapid heartbeats, excitation of the nervous system, or even death. This makes close monitoring of THO levels during therapy extremely crucial. Therapeutic drug monitoring is essential for optimizing the effects of treatments such as chemotherapy, which require strict control over the drug’s concentration in the patient’s blood to prevent severe side effects. However, most monitoring techniques are often time-consuming and demand complex procedures that can only be carried out by an expert. The same goes for THO detection methods.

To alleviate these problems, researchers over the years have developed low-cost electrochemical methods that are simple, highly sensitive, and rapid. One of these, a class of electrochemical tools that has recently gained momentum, is molecularly imprinted polymers (MIPs).

These tools have tailor-made molecular cavities that can recognize and bind to specific target molecules, just like receptors in our own body would. Their ability to do so is being widely used in several applications, including drug detection. In the new study, the SIT scientists developed

a disposable, paper-based THO sensor consisting of an electrode made of molecularly imprinted graphite. Since MIPs are designed using the target molecule as a template, the team used THO as a template when developing the sensor’s carbon-based electrode paste. The synthesized paste was then loaded onto a printed sensor chip and its THO detection abilities were tested.

The sensor was found to be highly sensitive (meaning it could detect even small amounts of THO and showed great selectivity towards the drug. In fact, the sensor could identify THO even in samples with THO concentrations as low as 2.5 µg/mL (µg=microgram, i.e., 1/1000 of a milligram). And what’s more, this sensor needs only 3 seconds to detect THO! It could do so even in whole bovine blood. This portable, lowcost, reliable, and rapid sensor has long-term stability and can be used for the real-time detection of drugs like THO without us depending on sophisticated equipment. Furthermore, the fabrication strategy provided in this study can be used to develop efficient electrochemical sensors for various other clinical interventions.

“Existing methods for the analysis of the drugs in blood are expensive and need specialized equipment. This can be a problem for developing countries dealing with a lack of resources and technicians,” said Assistant Prof. Aaryashree. “The paper-based sensor that we have developed is not only easy to use but also economical and can reduce the burden of drug analysis in developing countries. Further, its prototype can be used to develop a bedside therapeutic drug monitoring system, which will alert us of any overdose, avoiding side effects in patients taking these drugs.”

Image: Rapid and disposable Theophylline sensor (Photo courtesy of SIT) HospiMedica International May-June/2022

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Critical Care

POC Test Rapidly Detects Stroke Patients

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atients with stroke symptoms typically undergo a neurological exam followed by a CT scan to rule out a brain hemorrhage. If an ischemic stroke is diagnosed within four-and-a-half hours of experiencing symptoms, patients can receive the clot-dissolving medicine tPA. But currently, about 70% to 85% of patients miss that four-and-a-half-hour window, in part, because diagnosis takes too long. Also, about 10% of people with symptoms that mimic a stroke, such as a seizure, migraine headache or low blood sugar, receive tPA unnecessarily, putting them at risk of serious bleeding complications. Now, a new test could rapidly identify stroke patients upon arrival at the hospital, so that more patients could receive a CT scan and tPA treatment within the critical window.

Researchers at Cornell University (Ithaca, NY, USA; www.cornell.edu) who began investigating how sperm cells swim more than two decades ago have uncovered a new way to diagnose stroke and other diseases. They have co-founded a company, TETDiagnostics, to transform what they learned from sperm into a bio-inspired diagnostic technology. Ultimately, the researchers plan to develop this enzyme-

IV Injection Procedure Improves Sepsis Care

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ne in three patients who die in a hospital has sepsis. Sepsis occurs when the body’s immune response to an infection or injury goes unchecked.

Chemicals or proteins released into the blood lead to leaky blood vessels, inflammation and widespread blood clots. These conditions lead to impaired blood flow, which can cause organ damage and death. Now, researchers are developing a patent-pending treatment that could impact millions of lives each year.

Researchers at Purdue University (West Lafayette, IN, USA; www.purdue.edu) are developing biocompatible nanoparticles that treat sepsis systemically through intravenous injection. Polymyxin B, a traditional antibiotic, can inactivate endotoxins that cause a specific type of sepsis, but it may be too toxic for systemic application. For sepsis therapy, it mostly has been tested in extracorporeal blood cleaning, which is cumbersome and time consuming. In mouse models of sepsis, 100% treated with the nanoparticle were protected from excessive inflammation and survived.

“Our nanoparticle formulations reduce dose-limiting toxicity of Polymyxin B without losing its ability to inactivate endotoxins,” said Yoon Yeo who is leading the research team developing the biocompatible nanoparticles that treat sepsis systemically through intravenous injection. “This technology holds promise as a safe, convenient treatment option.”

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Image: New rapid diagnostic test to detect signs of a stroke or other brain injury (Image courtesy of TETDiagnostics)

based technology into a range of diagnostic tests that can be performed anywhere using a handheld device. Their initial research has shown that the test effectively diagnoses stroke and concussions.

The technology grew out of their research into the basic biology of sperm. Their work has already grown into a commercially available male fertility test and contributed to the first puppies born by in vitro fertilization.

Cells use a 10-step reaction to break down glucose to yield energy. In most cells, the enzymes involved are free-floating, but in sperm, they are anchored to the internal skeleton in the tail. The researchers copied this design and found they could add functions to nanoparticles by attaching different enzymes. The groups of the immobilized enzymes work even more efficiently than free-floating ones. The researchers considered other applications and settled on rapid, point-of-care diagnostic tests. Similar diagnostics, such as rapid COVID-19 tests and pregnancy tests, use antibodies, which are slower than enzymes, and give only yes-or-no results. In contrast, enzymes are “tiny biomachines” that grab onto disease biomarkers, change them and release them, giving off photons of light in the process. A lab instrument or handheld reader can detect the emitted light to quantify how much

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The researchers chose stroke as one of the first applications for their diagnostic technology because the faster a blood clot in the brain - called an ischemic stroke - can be diagnosed and treated, the less damage to the patient’s brain. Their test could rapidly identify stroke patients upon arrival at the hospital, as well as weed out people with stroke mimics, saving them from potentially dangerous tPA treatment. The company has already performed a small pilot study of 50 patients who received the TET diagnostic test along with their evaluation for stroke. TETDiagnostics plans to develop point-of-care tests for use in clinics, at home, in schools, or on the battlefield for applications ranging from neural injuries, to liver damage and to infectious diseases such as COVID. These tests can also be used in veterinary clinics, to make quick and affordable diagnoses in animals.

“Enzymes are super efficient and work very fast to generate a readout signal, so the results are available in just a few minutes,” said Roy Cohen, a researcher at Cornell’s College of Veterinary Medicine (CVM).

“Once we worked out how to attach the enzymes, there was an explosion of what we could do. There are so many disease biomarkers we can detect.”

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Robotic Platform Offers Diagnosis and Removal of Lung Cancer During Single Surgery

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ung cancer is among the leading causes of cancer-related death among men and women, and tends to spread quickly. It does not show any symptoms unless it is very advanced, and can silently spread to virtually any part of the body. This makes early screening and treatment critical. Traditionally, when a patient is diagnosed with a suspicious nodule or mass in their lung, they are referred to a pulmonologist, who may perform a lung biopsy to confirm if it is cancerous. If the lung nodule or mass is confirmed to be cancer, the patient may be referred to a thoracic surgeon, who determines if it can be surgically removed.

If it can, the patient undergoes another procedure on a separate day that requires additional anesthesia. On average, patients may wait up to three months from the time a nodule or mass is first discovered to when they receive a diagnosis and treatment. Now, a robotic-assisted minimally invasive biopsy platform allows for the diagnosis and removal of a lung cancer mass during one surgery, thus reducing anxiety and unnecessary waiting time for patients.

The Ion Endoluminal Platform by Intuitive Surgical (Sunnyvale, CA, USA; www. intuitive.com) enables the robotic-assisted

bronchoscopy procedure by creating a 3D map of the patient’s lungs using a CT scan.

The software then generates the safest and most efficient route through the lung to the nodule or mass. Once the route is determined, an ultrathin and ultra-maneuverable catheter is guided to the site of the lung nodule or mass, where it is marked and biopsied with precision and stability. Lymph nodes are also biopsied during the same procedure, using endobronchial ultrasound.

The samples are then evaluated on-site. If the lung nodule is determined to be an early-stage cancer, the surgical team uses the same navigational route to mark the area with dye to prepare for its removal. Then, the patient, still asleep, has a second robotic procedure to remove the lung cancer on the same day.

Ion is designed to fit easily into a bronchoscopy suite and integrate with existing technologies. Physical proximity has been taken into account with a design that keeps the surgical team close to the patient’s airways throughout the procedure. Although Ion does not require the use of cone beam CT for nodule biopsy, the system has been designed to be compatible with this technology. Ion leverages existing imaging technol-

ogies with radial endobronchial ultrasound (rEBUS), fluoroscopic, virtual, and live views of the lung all unified in a single system. Additionally, Ion’s network connection allows access to system data. The data dashboard utilizes this automatically collected system data and provides it back to the user. The surgical team can see their data in one place.

The dashboard provides a detailed view of system utilization and procedure data.

The surgical team can view information on their case times, instruments and accessories utilization, the target nodule location in the lung, as well as the size of a lesion.

Image: Ion robotic-assisted endoluminal platform for minimally invasive peripheral lung biopsy (Photo courtesy of Intuitive Surgical)

Bio Glue Can Replace Sutures and Staples Cont’d from cover

Now, a new ‘bio-glue’ has the capability to replace and revolutionize tissue adhesives (like fibrin glue) currently utilized in clinical settings, triage situations and mass casualty incidents. The discovery of the new bio-glue designed using materials already approved by the U.S. Food and Drug Administration (FDA) for other applications may mean an end to surgical sutures and staples made of plastic or

stainless steel.

A team of researchers at Western University (Ontario, Canada; www.westernu.ca) and University of Manitoba (Winnipeg, Canada; www. umanitoba.ca) has developed the first-ever hydrophobic (water-hating) fluid, which displaces body fluids surrounding an injury allowing for near-instantaneous gelling, sealing and healing of injured tissue. Since the new bio-glue forms Cont’d on page 17

Image: Bio-glue enables near-instantaneous gelling, sealing and healing of injured tissue (Photo courtesy of Pexels) HospiMedica International May-June/2022

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Robotic System with Single-Use Instrument Concept Eliminates Cross-Contamination Risk

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p to now the use of robot-assisted procedures has been extremely resource intensive and therefore, not a viable option for many clinics. Now, a new robot-assisted, minimally invasive surgical system based on a unique and consistent single-use concept reduces the associated risk of contamination and at the same time avoids the costs of cleaning and sterilizing the instruments.

Avateramedical GmbH’s (Jena, Germany; www.avatera.eu) avatera is the first German system for robot-assisted, minimally invasive surgery and was developed as a high-quality solution for minimally invasive robotic surgery. Tailored to address specific user needs, the cutting-edge system enables precise keyhole surgery (so-called laparoscopy) with the highest level of safety for patients and maximum ergonomic comfort for surgeons and surgical teams. Its single-use concept for surgical instruments eliminates the need for complex and expensive sterilization processes, saving costs while always providing surgeons with new, reliable instruments, removing the risk of cross-contamination.

Additionally, the avatera system builds on and improves the features and functionality of currently available surgical robots, is easy and comfortable to use, and is specifically tailored to the needs of surgeons and their teams. The built-in seat and individual ergonomic adjustment options allow surgeons to work comfortably even during very long operations. An open design and low noise levels allow for ease of communication for the surgical teams. The compact system does not require much space and can easily fit in a wide variety of operating rooms.

The avatera robot-assisted, minimally invasive surgery system has successfully completed the first 10 surgeries in humans and has now been introduced into everyday clinical practice at the first hospital worldwide, the University of Leipzig Medical Center. Additionally, avatera has received the CE mark and is approved for minimally invasive surgery in urology and gynecology in the European Economic Area. Currently, the system is being rolled out at partner sites which will allow the company to gain additional experience in clinical routines.

“With the first in-human surgeries, we are entering a new exciting chapter in our company’s history,” said Greg Roche, CEO of avateramedical N.V. “It is our vision to make cutting-edge, efficient robot-assisted surgery accessible for every patient around the world.”

“The first surgical procedures on patients were performed at the University of Leipzig Medical Center to remove prostate and kidney tumors. We are thrilled that these procedures were so successful and that surgeons and their patients are now beginning to benefit from our work,” added Andreas Wegner-Berndt, Managing Director of avateramedical GmbH.”

Bio Glue Can Replace Sutures and Staples

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a strong bond with the adjacent tissue, it virtually eliminates detachment. In extensive preclinical studies, it was able to seal a punctured lung, heart, artery and even a fractured skull. For the new bio-glue, the primary material is silicone, which does not absorb the water from the tissue, so it sticks.

“Tissue adhesives that can perform in the presence of blood, water and other proteins in the body are the holy grail for instant wound closure and hemostasis, especially when time is critical in rescue operations and emergency responses,” said Kibret Mequanint, a Western chemical and biochemical engineering professor. “Fibrin glue, and the like, often fail to displace fluids around an injury. This failure means (current tissue adhesives) never strongly adhere to the wound and often detach within the first hour or two.”

“This new bio-glue is transformative in its deceptive simplicity,” added Mequanint. “There was no tissue reaction to it and the healing was fast. Silicone forms a strong adhesion, so you don’t have to worry after the repair that it’s going to reopen and cause more problems beyond the initial injury.”

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HospiMedica International May-June/2022

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The Maquet Alphamaxx mobile universal surgical table offers maximum load capacity, flexibility and comfort. It allows for adaptation to the patient’s body size, and can be easily equipped for any surgical discipline.

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New Transport System for Heart Transplants

Cont’d from cover

Now, groundbreaking research from a recent study has found that patients receiving hearts transported using a novel preservation and transportation device had a superior oneyear survival as compared to donor hearts stored on ice.

The SherpaPak Cardiac Transport System (CTS) from Paragonix Technologies, Inc. (Cambridge, MA, USA; www.paragonixtech nologies.com) is an FDA-cleared and CEmarked donor heart transport and preservation device that uses proprietary phase change technology to prevent exposure to excessive temperature reduction. The rigid, pressure controlled, leak-proof dual-canister system protects the donor heart from physical and thermal trauma while Bluetooth connection and the Paragonix App ensure real-time monitoring, tracking, and communication.

The new multi-center study compared SherpaPak CTS to the use of conventional cold storage using ice in the preservation of donor hearts destined for transplantation. The study on one-year transplant patient outcomes following heart transplant surgery focused on post-transplant outcomes and survival, and utilized data collected by the GUARDIAN-Heart Registry, the world’s largest clinical database specifically dedicated to heart preservation.

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The US Multi Center 1-year Transplant Survival Analysis of the GUARDIAN Registry included 569 adult patients who received heart transplants between October 2015 and January 2022. The analysis showed a statistically significant 72% reduction in Severe Primary Graft Dysfunction (PGD) rates. The one-year survival rate in patients where traditional cold storage was used was 88.7%. In contrast, the one-year survival rate in patients where the SherpaPak was used was 96.4%.

This finding represented an 8.7% increase in one-year survival when using the SherpaPak for donor heart preservation.

Additionally, several other post-operative improvements were noted by the propensity matched study in favor of the SherpaPak cohort such as 38.5% reduction in all post-transplant MCS (mechanical circulatory support), 66.3% reduction in post-transplant ECMO (extra corporeal membrane oxygenation)/ VAD (ventricular assist device), 59.7% reduction in newly placed IABP (intra-aortic balloon pump) and 71.9% reduction in severe PGD (primary graft dysfunction).

“The results of this study suggest that using ice to preserve and transport donor hearts is a potentially inferior method for organ preservation,” said Dr. Andreas Zuckermann, the EU Principal GUARDIAN Investigator, Director of Cardiac Transplantation, and Associate Professor of Surgery at Medical University of Vienna.

“A 96.4% 1-year survival rate in the propensity

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matched analysis utilizing the SherpaPak is an encouraging sign that this technology for advanced organ preservation is having an impact on the clinical outcomes of heart transplantation. Advanced preservation of donor hearts should be a seriously considered by all transplant centers when assessing the impact on clinical outcomes outlined in this research.”

“With advanced technology like the SherpaPak, we can now demonstrate that we provide advanced care and improved outcomes for the vulnerable patient population of heart transplant recipients. With over a third of all US transplant centers utilizing the SherpaPak device, we look forward to supporting transplant centers across the US and Europe as they transition to this innovative technology as the standard of care,” said Dr. Lisa Anderson, CEO and President of Paragonix.

Image: Paragonix SherpaPak CTS is an FDA cleared and CE marked preservation device for heart transportation (Photo courtesy of Paragonix Technologies)

Automated Endoscopic Ultrasound Biopsy Device Advances Precision Medicine

ndoscopic biopsy is performed by a gastroenterologist who accesses the targeted gastrointestinal (GI) tumor utilizing an ultrasound visualization endoscope. Suspect GI tumor locations include submucosal lesions, mediastinal masses, lymph nodes, intraperitoneal masses, and within GI related organs such as the pancreas and liver. Today's endoscopic biopsy devices have limitations in consistently obtaining quality tissue with sufficient quantity, which can result in sample tissue fragmentation, inadequate tissue amount, and blood contamination. Now, a new endoscopic ultrasound biopsy device

featuring a unique motorized, automated rotational cutting needle is designed to obtain biopsies for definitive diagnosis of pancreatic cancer and other life-threatening GI cancers more quickly and less traumatically than current products.

Limaca Medical’s (Yokneam, Israel; www.limaca-medical.com) Precision-GI device is designed to obtain tumor tissue within or adjacent to the GI tract. It is deployed and operated through an instrument channel in the endoscope to biopsy the tumor. While all existing endoCont’d on page 19 HospiMedica International May-June/2022

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Surgical Techniques

Surgical Robot Uses Preoperative CT Scans to Plan Out Spinal Fusions

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s personalized medicine continues to garner more importance in the field of health care, orthopedic surgeons use advances in imaging technology, coupled with the latest robotics capabilities, to improve the likelihood of achieving successful outcomes for patients undergoing spinal surgery. By utilizing robotic systems and other advanced technologies, many spine surgeries may be performed in a minimally invasive fashion, which is associated with numerous advantages including: less damage to muscles, reduced blood loss and operative time, decreased complication rates, quicker recoveries, and ultimately better clinical outcomes. Now, a novel technology allows orthopedic surgeons to upload preoperative CT scans of patients into a next generation robotic platform to plan out the procedure in advance and calculate trajectories of implants for spinal operations like fusions, which allows for the placement of screws more safely and accurately.

The Mazor X Stealth Edition from Medtronic plc (Dublin, Ireland; www.medtronic.com) offers a fully-integrated procedural solution for surgical planning, workflow, execution and confirmation of spine surgeries. With features such as customizable implant selection, optimal implant trajectories and 3D analytics, planning allows surgeons to work towards construct optimization and make the procedure predictable.

The revolutionary new technology uses cutting-edge software to plan the surgical procedure, then uses a robotic arm to guide implants and instruments through the steps of the surgical process with precision,

while simultaneously using real-time imaging feedback to ensure the plan is being carried out as desired.

The Mazor X Stealth Edition operates on three principals: first, the surgeon can plan and visualize the surgery beforehand to study multiple levels and the entire process; second, the robotic guidance system will be an extension of the doctor during the process and is intended to enable execution with precision; and third, the doctor can visualize progress in real-time. State of the art registration and mechanical stability are critical to establish robotic precision. The Mazor X platform secures a closedloop connection between the bed-mounted robotic arm, the patient secured on the bed, and a rigid fixation between the robot and patient’s skeletal anatomy. The robot is table mounted for a small OR footprint.

Image: MAZOR X Stealth Edition is a robotic guidance system for spinal surgery (Photo courtesy of Medtronic)

Automated Endoscopic Ultrasound Biopsy Device Advances Precision Medicine

Cont’d from page 18

scopic ultrasound fine needle biopsy (EUS-FNB) devices require manual hand operation, Precision GI features a unique motorized, automated rotational cutting needle for successful tissue acquisition. The automated design provides for more efficient and effective diagnosis of GI cancers since it is designed to yield significantly superior quality and quantity of diagnostically relevant biopsy tissue.

Initial cases from Limaca's comparative feasibility clinical study, which is ongoing, demonstrates that Precision GI obtained contiguous intact core tissue samples fully adequate for definitive diagnosis of pancreatic lesions. The clean, non-contaminated tissue samples provided a high percentage of tumor content, with less blood and extraneous fluids. Limaca’s Precision-GI endoscopic ultrasound biopsy product has received a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Under the program, the FDA will provide Limaca with the opportunity to provide its feedback during the pre-market phase and prioritized review of the device submission.

"We are pleased with the FDA's decision to grant the Breakthrough Device Designation to Precision-GI," said Carl Rickenbaugh, Limaca's CEO. "At Limaca, our vision is to ensure that endoscopic biopsies always achieve a definitive diagnosis to enable optimal and timely GI-cancer treatment. We are dedicated to the mission to provide a far better endoscopic biopsy experience for the endoscopist and patient, with the goal to achieve a faster, more efficient biopsy yield with highly consistent results.

With the Breakthrough Device Designation, we look forward to accelerating our progress toward our goal of obtaining the FDA's 510(k) clearance to bring Precision-GI to patients in the US in the near future."

"Precision-GI is an automated, motorized endoscopic biopsy product that has the potential to improve our biopsy results for the evaluation of gastrointestinal malignancies.

Endoscopic biopsy is a highly specialized, high skill procedure. We welcome the innovation of Precision-GI which can provide automation and standardization of outcomes

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HospiMedica International May-June/2022

with less variation from operator to operator," said Seth A. Gross, MD, Clinical Chief, Division of Gastroenterology and Hepatology, NYU Langone Health. "Our field is driving toward patient centric individualized cancer therapy, known as Precision Medicine, which requires consistently high quality and quantity of endoscopic biopsy tissue, enabling optimal matching of the tumor's genetic profile to personalize a patient's treatment plan."

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WHITE LIGHT ENDOSCOPIC IMAGING SYSTEM OPTOMEDIC

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LED3 SC surgical light features a single-color LED (SC) with a multi-faceted lens system for lowest shadiness in the light field. It offers a high contrast, lifelike and precise illumination of the surgical field.

The EuroVac H-50 surgical suction pump is an electric, high-vacuum and high-flow suction pump designed as a suction device for operation rooms where a high-suction capability and a rapid response is required.

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Surgical Robot Found Safe and Effective for Localized Prostate Cancer Surgery

n initial evaluation of a new surgical robotic system has found it to be “feasible, safe, and effective” for the treatment of early-stage prostate cancer. The new system, called the KangDuo Surgical Robot-01, offers high accuracy and surgical success with low complication rates and a high comfort level for the surgeon – and may provide a less-costly alternative to current surgical robots.

In the study, researchers at Peking University (Beijing, China; www.pku.edu.cn) analyzed their experience using the KangDuo system to perform robot-assisted radical prostatectomy (RARP) in 16 men with localized prostate cancer. The patients, median age 66 years, had localized cancers that had not spread beyond the prostate gland. Initial results showed that the KangDuo system is feasible, safe, and effective

for management of localized prostate cancer.

All procedures were successfully completed, with no major problems requiring conversion to traditional open surgery. Seventy-five percent of patients had “clear” surgical margins, suggesting that the cancer was completely removed by surgery. Urinary incontinence is a potential complication after prostate cancer. In the new study, the continence rate was 87.5% (14 of 16 patients) at one month after catheter removal. There were no serious complications and no need for blood transfusions.

Developed in China, the KangDuo system has shown promising results in other types of operations. The KangDuo robotic system incorporates several important features to optimize hand-eye coordination and allow for normal and adjustable neck posture. On

ergonomic evaluation, the surgeon reported a “high level of comfort” using the robotic surgeon, with “acceptable” levels of mental and physical demand. Further refinements are planned, including a tactile feedback system and the ability to perform long-distance operations using 5G technology. Approval of the KangDuo system is expected soon, first in Chinese market and worldwide shortly thereafter.

“Although the price has not yet been determined, the emergence of new robotic surgery systems lowers the cost of robotic surgery, which could benefit more patients,” the researchers stated.

Smart Stent for Hemodynamic Monitoring Could Eliminate Need for Angiogram Imaging

Cont’d from cover

A team of researchers is now trying to improve the odds for patients with the development of an implantable soft electronic monitoring system.

Researchers at the Georgia Institute of Technology (Atlanta, GA, USA; www.gatech. edu) have developed a new device consisting of a smart stent and printed soft sensors that is capable of wireless real-time monitoring of hemodynamics without batteries or circuits.

When the device is installed in a patient with atherosclerosis, in addition to expanding and preventing the artery from narrowing, like a traditional stent, restoring normal blood flow, it will also provide a constant flow of data.

The system seeks to circumvent the need for an angiogram or other imaging requirements that are the current standard way to monitor hemodynamics. Such methods can also be expensive and in rare instances, particularly with patients also struggling with diabetes, the

dyes and radiation used in angiogram imaging can cause cancer.

The wireless smart stent platform, integrated with soft sensors, is operated by inductive coupling to offer wireless real-time monitoring that can detect a wide range of vascular conditions. Inductive coupling uses magnetic fields for wireless energy transfer. It is similar to a wireless charger used for the phone, smartwatch, or other devices – they are gaining energy from the magnetic field created by the charger. The researchers have tested their

wireless implantable system on animal models although there is still plenty of work to do.

“This electronic system is designed to wirelessly deliver hemodynamic data, including arterial pressure, pulse, and flow, to an external data acquisition system, and it is super small and thin, which is why we can use a catheter to deliver it, anywhere inside the body,” said Woon-Hong Yeo, a researcher at Georgia Institute of Technology.

“Basically, you can put this sensor system anywhere inside the body,” added Yeo. “The other thing about this technology platform is, in addition to being an implantable sensor system, it can be used as a wearable system.

Think about a smartwatch and how much of its bulk is taken up by circuits or batteries. If you remove all of that, you have a device that is thinner than a typical Band-Aid, an almost invisible health monitor that you can wear anywhere.”

HospiMedica International May-June/2022

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Industry News

Siemens to Offer Virtual Reality Based Surgical Training in Partnership with PrecisionOS

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iemens Healthineers (Erlangen, Germany; www.siemens-healthineers. com) is offering immersive virtual reality (VR) training in partnership with PrecisionOS (Vancouver, Canada; www. precisionostech.com) to help surgeons and technicians practice the use of its mobile 3D C-arm Cios Spin for intraoperative quality control and surgical workflow guidance. Multi user, peer-to-peer training sessions will enable

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as well as collaboratively in a hyper-realistic environment,” said Janine Weidling, Global Head of Education Services Advanced Therapies at Siemens Healthineers. “This increases the quality of procedure- and imaging-related skills for the users and provides them with more certainty, especially in demanding surgical cases.”

“Providing better training for surgeons and technicians will promote better teamwork and experience for everyone in the OR,” added Danny Goel, M.D., orthopedic surgeon and CEO, PrecisionOS. “The result will be better patient care and improved OR safety.”

Medtronic Acquisition to Expand ENT Portfolio

edtronic plc (Dublin, Ireland; www.medtronic.com) has completed the acquisition of Intersect ENT (Menlo Park, CA, USA; www.intersectent. com), thereby expanding the company's comprehensive ear, nose, and throat (ENT) portfolio with innovative products used in sinus procedures to improve post-operative outcomes and to treat nasal polyps.

Medtronic has acquired Intersect ENT's PROPEL and SINUVA (mometasone furoate) sinus implant product lines and technology, intellectual property. Intersect ENT's product lines and customer base will further the efforts of Medtronic to have a positive impact for patients who suffer from chronic rhinosinusitis (CRS). CRS is one of the most common health care problems in the U.S., with approximately 30 million adults diagnosed annually. It has been associated with lost days of work, decreased productivity, and even depression and anxiety, with most patients reporting 5-15+ years of suffering and medical treatment.

Through this acquisition, Medtronic gains PROPEL and SINUVA, which are unique bioabsorbable, steroid-eluting implants for sinus patients. PROPEL implants are inserted following endoscopic sinus surgery to maintain sinus patency and provide localized steroid delivery. SINUVA implants are designed for use in the physician's office setting for the treatment of nasal polyps in adult patients who have had ethmoid sinus surgery.

"By combining Intersect ENT's groundbreaking localized drug delivery products with the leading navigation and powered instruments of Medtronic, we can now equip physicians with the right tools for many

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the exchange of surgical procedure knowhow on a virtual patient and will lead to an enhanced surgeon/technician collaboration.

Conventional 2D imaging may not always provide enough information to safeguard correct placement of screws and implants.

Intraoperative 3D imaging helps transform care delivery by improving surgical outcomes. To provide 3D capabilities that can be seamlessly integrated into clinical routine, Siemens has developed Cios Spin - a mobile 2D and 3D C-arm for intraoperative quality assurance. Easy to integrate into any surgical routine, it features dedicated 3D technologies that allow surgeons to confirm their planned results. The Cios Spin offers optimal 3D and 2D imaging for the precise intraoperative guidance and versatility to advance therapy outcomes.

“PrecisionOS’ VR software allows for surgeons to practice and behave authentically

HospiMedica International May-June/2022

unique patient needs," said Vince Racano, president of the ENT business, which is part of the Neuroscience Portfolio at Medtronic.

"This acquisition expands our portfolio, and we can now provide a more comprehensive continuum of care for CRS patients while supporting the bold ambition of Medtronic to be the global healthcare technology leader."

"We believe the market leadership and global footprint of Medtronic, coupled with enterprise resources to fuel pipeline innovation and commercialization, will advance our reach to customers and patients more quickly and serve our shared vision of improving patient access, outcomes, and satisfaction for millions of people around the world who suffer from ENT diseases," said Thomas West, president and CEO of Intersect ENT. "We are thrilled to combine these two companies as we now officially work together to bring more ENT options to patients.

I am especially proud of our dedicated Intersect ENT employees, whose entrepreneurial spirit and passion for innovation have driven our ability to achieve this milestone."

Alliance with GE Healthcare in Ambulatory Surgery In a related development, Medtronic entered into a collaboration agreement with GE Healthcare (Chicago, IL, USA; www. gehealthcare.com) directed at cardiac and

peripheral vascular procedures in Ambulatory Surgery Centers (ASCs) and Office Based Labs (OBLs).

Since CMS approved payments for certain cardiovascular procedures in 2020, fixed carm imaging systems have been used more and more frequently in ASCs and OBLs for cardiac and peripheral vascular procedures.

Now, a new collaboration aims to meet the growing need for outpatient care.

GE’s role would feature consultative planning, construction, a comprehensive suite of equipment (including imaging, monitoring, and ultrasound), as well as service and digital solutions, including the Edison-powered AutoRight A.I.-based interventional imaging chain, which can help clinicians provide the right image at the right dose automatically for each patient. Medtronic would contribute its extensive portfolio of products for a diverse range of service lines in the ASC and OBL, from cardiac rhythm to pain management, peripheral vascular to kyphoplasty.

“As our customers open centers outside the hospital, they are looking for support beyond the devices used in medical procedures,” said Adam King, Senior Director of U.S. Enterprise Accounts and Ambulatory Surgery Centers at Medtronic. “From products and devices to equipment and services, we provide a full range of technologies and solutions. Our collaboration with GE Healthcare was formed to better serve the growth of our ASC and OBL customers with extensive technologies and dedicated teams who have expertise in outpatient services and can address all aspects of this evolving sector.”

ATTENTION: Due to the CORONAVIRUS PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event

International Calendar

For a free listing of your event, or a paid advertisement in this section, contact:

20-22; Singapore; sg-apics.com CMEF Spring 2022 China International Medical Equipment Fair. Aug 21-24; Shanghai, China; cmef.com.cn

International Calendar, HospiMedica International

IndoHealthCare 2022. Aug 25-27; Jakarta, Indonesia; indohealthcareexpo.com

E-mail: info@globetech.net

JUNE

2022

ICE 2022 – 20th International Congress of Endocrinology.

Aug 25-28; Virtual Venue; isendo.org

SCR 22 – Swiss Congress of Radiology. Jun 23-25; Fribourg, Switzerland; congress.sgr-ssr.ch

EULAR 2022 – European Congress of Rheumatology. Jun 1-4; Copenhagen, Denmark; congress.eular.org ASCO 2022 – Annual Meeting of the American Society of Clinical Oncology. Jun 3-7; Chicago, IL, USA; asco.org EuroAnaesthesia 2022 – European Society of Anaesthesiology. Jun 4-6; Milan, Italy; euroanaesthesia2022.org APSCVIR 2022 – 16th Annual Meeting of the Asia Pacific Society of Cardiovascular and Interventional Radiology. Jun 4-6; Kobe, Japan; apscvir.com ESPR 2022 – 56th Annual Meeting of the European Society of Paediatric Radiology. Jun 6-10; Marseille, France; espr2022.org CARS 2022 – Computer Assisted Radiology and Surgery. Jun 7-10; Tokyo, Japan; cars-int.org 22nd MEDEXPO Africa 2022. Jun 9-11; Nairobi, Kenya; expogr.com/kenyamed SIIM 2022 – Annual Meeting of the Society for Imaging Informatics in Medicine. Jun 9-11; Kissimmee, FL, USA; siim.org EHA 2022 – Annual Congress of the European Hematology Association. Jun 9-12; Vienna, Austria; ehaweb.org SIR 2022 – 47th Annual Meeting of the Society of Interventional Radiology. Jun 11-16; Boston, MA, USA; sirmeeting.org

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Expo Med 2022. Aug 31 - Sep 2; Mexico City, Mexico; expomed.com.mx

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ESRA 2022 – 39th Annual Congress of the European Society of Regional Anaesthesia and Pain Therapy. Jun 22-25; Thessaloniki, Greece; esra2022.com

ESC Congress 2022 – European Society of Cardiology. Aug 26-29; Barcelona, Spain; escardio.org

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ATTENTION: Due to the CORONAVIRUS PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event Medicine. Oct 10-15; Guadalajara, Mexico; commec.org EUSEM 2022 – 16th European Emergency Medicine Congress.

Oct 15-19; Berlin, Germany; eusem.org 4th MedExpo Ethiopia 2022. Oct 18-20; Addis Ababa, expogr. com/ethiopia/medexpo Asia Health 2022. Oct 19-21; Bangkok, Thailand; medlabasia. com ESSO 41 – 41st Congress of the European Society of Surgical Oncology. Oct 19-21; Bordeaux, France; esso41.org ANESTHESIOLOGY 2022 – Annual Meeting of the American Society of Anesthesiologists. Oct 21-25; New Orleans, LA, USA; asahq.org ECISM LIVES 2022 – Annual Congress of European Society of Intensive Care Medicine. Oct 22-26; Paris, France; esicm.org ASTRO 2022 – 64th Annual Scientific Meeting of the American Society for Radiation Oncology. Oct 23-26; San Antonio, TX, USA; astro.org ISS 49th Annual Meeting – International Skeletal Society. Oct 23-28; Barcelona, Spain; internationalskeletalsociety.com Africa Health 2022. Oct 26-28; Johannesburg, South Africa; africahealthexhibition.com 14th World Stroke Congress – World Stroke Organization.

Oct 26-29; Singapore; worldstrokecongress.org RANZCR 2022 – 72nd Annual Scientific Meeting of The Royal Australian and New Zealand College of Radiologists. Oct 2730; Adelaide, Australia; ranzcr.com ESGO 2022 – 23rd European Congress on Gynaecological Oncology. Oct 27-30; Berlin, Germany; congress.esgo.org 14th Congress of the Pan American and Iberian Federation of Critical Medicine and Intensive Therapy. Oct 31 - Nov 5; Lima, Peru; paneiberico-lima2022.com

NOVEMBER TurkRad 2022 – 43rd Turkish National Radiology Congress.

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Care & Emergency Medicine. Mar 21-24; Brussels, Belgium; isicem.org

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RSNA 2022 – Annual Meeting of the Radiological Society of North America. Nov 27 - Dec 1; Chicago, IL, USA; rsna.org

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ESTRO 2023 – Annual Congress of the European Society of Radiology & Oncology. May 12-16; Vienna, Austria; estro.org

SAGES 2023 – Annual Meeting of Society of American Gastrointestinal and Endoscopic Surgeons. Mar 29 – Apr 1; Montreal, Canada; sages.org

ECE 2023 – 25th European Congress of Endocrinology. May 13-16; Istanbul, Turkey; ese-hormones.org

DECEMBER ASCA 2022 – 14th Meeting of the Asian Society of Cardiothoracic Anesthesia. Dec 1-4; Chiang Mai, Thailand; asca2022.com Zdravookhraneniye 2022 – Russian Health Care Week. Dec 5-9; Moscow, Russia; zdravo-expo.ru

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ECIO 2023 – European Conference on Interventional Oncology. Apr 16-19; Stockholm, Sweden; ecio.org

91st EAS Congress 2023 – European Atherosclerosis Society.

May 21-24; Mannheim, Germany; eas-society.org

ARRS 2023 Annual Meeting – American Roentgen Ray Society. Apr 16-20; Honolulu, HI, USA; arrs.org

MedtecLIVE 2023. May 23-25; Nuremburg, Germany; medteclive.com

HIMSS 2023 - Healthcare Information and Management Systems Society. Apr 17-21; Chicago, IL, USA; himss.org

Hospitalar 2023. May 23-26; Sao Paulo, Brazil; hospitalar. com

12th Asian Conference on Emergency Medicine (ACEM). Apr 20-23; Manila, Philippines; asiansem.org

ESOC 2023 – 9th European Stroke Conference. May 24-26; Munich, Germany; eso-conference.org

24th Tanzania MedExpo Africa 2023. Feb 16-18; Dar es Salaam, Tanzania; expogr.com/tanzania/medexpo

143rd Annual Meeting of the American Surgical Association (ASA). Apr 20-22; Toronto, Canada; americansurgical.org

Nordic Congress of Radiology 2023. May 24-26; Helsinki, Finland; ncr2023.fi

SAR 2023 – Annual Scientific Meeting of the Society of Abdominal Radiology. Feb 26 - Mar 3; Austin, TX, USA; abdominalradiology.org

DCK 2023 – 139th Congress of the German Society for Surgery (DGCH). Apr 25-28; Munich, Germany; dgch.de

34th Congress of European Federation of Societies for Ultrasound in Medicine and Biology (EUROSON). May 25-27; Riga, Latvia; euroson2023.com

Critical Care Congress 2023 – 52nd Annual Meeting of the Society of Critical Care Medicine (SCCM). Jan 15-18 New Orleans, LA, USA; sccm.org Medical Japan 2023 Osaka – International Medical and Elderly Care Expo. Jan 18-20; Osaka, Japan; medical-jpn.jp Arab Health 2023. Jan 30 - Feb 2; Dubai, UAE; arabhealthonline.com

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MARCH 50th Annual Meeting of the Japanese Society of Intensive Care Medicine (JSICM). Mar 2-4; Kyoto, Japan; jsicm.org ACC.23 – American College of Cardiology’s 70th Annual Scientific Session & Expo. Mar 4-6; New Orleans, LA, USA; accscientificsession.acc.org AAOS 2023 Annual Meeting – American Academy of Orthopaedic Surgeons. Mar 7-11; Las Vegas, NV, USA; aaos.org ExpoMED Eurasia 2023. Mar 16-18; Istanbul, Turkey; expomedistanbul.com

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