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Superfeet to Produce 30,000 Respirator Masks for Local Healthcare Workers and Hospitals

A week after a national announcement opening their doors to help those needing access to personal protective equipment (PPE) to combat the COVID-19 pandemic, Superfeet and sister company Flowbuilt Manufacturing have started production of PPE masks with 3D-printed elements.

It took less than a week for Superfeet employee-owners to mobilize their product development and operations departments to pivot from insole production to making life-saving equipment using their Ferndale 3D printing and manufacturing facilities. Approximately 30,000 of these PPE masks will be produced and distributed to hospitals in the Pacific Northwest immediately.

“We started conversations with local hospitals and healthcare workers last week and discovered a massive need for PPE, as demand has skyrocketed over the past few weeks,” says John Rauvola, CEO and President at Superfeet. “You can feel the pride our team of employee-owners takes in being able to create something tangible to help combat this pandemic and better protect our community’s first line of defense.”

When Superfeet opened their doors to help those needing access to PPE, they sent a call-to-action challenging their local community to get involved. Another Washington-based company, Pioneer Aerofab– a business focused on manufacturing airplane interiors – quickly joined the cause and is supplying the mask’s hood portion. Tim Williamson, Pioneer Aerofab’s Owner and CEO explains, “It’s easy to be overwhelmed by the sheer magnitude of COVID-19 and its effect on our daily lives and those around the world. Looking at how you can make an impact on a local level is the best place to start. That’s precisely what we did when we heard about Superfeet’s plan.”

Superfeet continues to offer their 3D printers and manufacturing capabilities to the effort to combat COVID-19.

Medical facilities in need of personal protective equipment can reach out to covidresponse@superfeet.com to see if Superfeet can be of assistance.

Critical Care Surgery Team Develops Surgery Blueprint for Essential Operations During COVID-19

As patients with Coronavirus Disease 2019 COVID-19) flood hospitals, the health care system must not only determine how to redeploy limited resources and staff to care for them but must also make well-calculated decisions to provide other types of critical care. For surgeons, this type of critical care involves performing an emergency operation to treat a ruptured appendix or perforated colon—to both virus-exposed and non-exposed patients—while keeping both hospital personnel and non-exposed patients safe.

To help guide hospital surgery departments through this crisis, the acute surgery division at Atrium Health’s Carolinas Medical Center in Charlotte, N.C., has developed a tiered plan for marshaling limited resources, which the authors have published as an “article in press” on the American College of Surgeons website ahead of print publication in the Journal of the American College of Surgeons. Atrium Health consists of more than 7,500 beds at 50 hospitals in North Carolina, South Carolina, and Georgia.

“The principles we address—such as triage criteria, beneficence, and justice—are ethical principles that we all learn as physicians, but it’s also looking at the scenarios that are unfolding around the world, in China and Italy, and how health care providers are having to deal with this crisis on the fly,” said lead author Samuel Wade Ross, MD, MPH, an assistant professor of surgery in the division of acute care surgery at Atrium Health Carolinas Medical Center. “We felt it would be better to have thought about this before the tsunami of COVID-19 patients is upon us.”

The Atrium Health recommendations came about when acute care surgery team members approached the department of surgery leadership with the concept, drawing upon their different areas of expertise in disaster management. In addition to Dr. Ross’s background in public health, coauthor Cynthia W. Lauer, MD, FACS, was a military surgeon who served two tours in Afghanistan; William S. Miles, MD, FACS, FCCM, brought extensive experience in surgical critical care management; and Ashley Britton Christmas, MD, FACS, is president of the Eastern Association for the Surgery of Trauma.

Key steps include reassigning acute care surgeons to care for COVID-19 patients, creating principles for triaging surgical cases, deferring non-emergency operations or sending these procedures to less-strained centers, and considering “battlefield promotion” for senior surgical residents. The suggestions employ recommendations included in the American College of Surgeons (ACS) recently released guidance for triage of non-emergent operations and recommendations for elective surgeries during the COVID-19 outbreak, Dr. Ross said.

The ACS triage recommendations, incorporating expertise from Allan Kirk, MD, PhD, FACS, of Duke University Medical Center, and the Elective Surgery Acuity Scale (ESAS) developed by Sameer Siddiqui, MD, FACS, of St. Louis University, provide guidance to determine the need for surgery in a hospital dealing with a COVID-19 surge. ESAS recommends that only essential operations, such as those for acute symptoms and most types of cancers, be performed in a hospital with a high COVID-19 population; all other operations should be postponed or sent to an outpatient facility or a hospital with a no-to-low COVID-19 population.

“Those acuity levels would help you decide if a surgery was emergent, urgent, or if it was completely elective; we actually started using those levels here at Atrium Health,” Dr. Ross said.

The Atrium Health model uses an operating room case screening board that reviews the day’s scheduled cases and determines if these procedures really must be done based on the hospital’s response level. Response levels range from “Alert,” when disaster preparedness must begin and non-time sensitive elective cases and even high-risk cases should be avoided, to “Condition Zero,” which Dr. Ross described as “wartime footing,” and only the most pressing emergency operations would be done.  “Most centers in the country now are probably beyond the Alert status,” he said. Atrium Health is following the guidance of both the Surgeon General and ACS to reschedule all non-essential operations, procedures, and ambulatory appointments.

The recommendations can be used in any type of hospital setting, Dr. Ross said, and have been adopted by all surgical subspecialties systemwide at Atrium Health. “It’s really important to plan now so that when a COVID-19 patient surge occurs, there’s a blueprint in place,” he said.

The most comprehensive recommendations involve personnel. “As the hospital is getting more and more COVID-19 patients and as acute care surgeons are going to have to flex to do more intensive care unit (ICU) critical care, our plan is to shift away from doing the emergency surgery and trauma in order to shift toward focusing on the ICU and pulling more resources from the medical intensivists that cover those patients,” Dr. Ross said.

Older health care providers, at higher risk of contracting COVID-19, could be assigned lower-risk roles, such as telemedicine and virtual critical care triage. Fellows and senior medical residents can be advanced to attending status to free up general surgeons for emergency surgery and trauma. “Acute care surgeons are integrated within the emergency department, the operating room, and the ICU,” Dr. Ross said. “We’re really the Swiss Army Knife of the hospital.”

Attrition is also a consideration as staff may become exposed to the virus. The recommendations state that agreements should be in place to shift surgical services among different facilities, and large health systems or regional cooperatives could use a pool of surgeons to deploy at satellite hospitals that run short of staff.

In addition to Drs. Lauer, Miles and Christmas, Dr. Ross’s other coauthors are John M. Green, MD, FACS; Addison K. May, MD, MBA, FACS; and Brent D. Matthews, MD, FACS; all with the division of acute care surgery at Atrium Health’s Carolinas Medical Center.

The authors have no financial relationships to disclose.

Citation: Maximizing the Calm Before the Storm: A Tiered Surgical Response Plan For COVID-19. Journal of American College of Surgeons.

COVID-19 FDA Update: Daily Roundup

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. These drugs will be distributed from the SNS to states for doctors to prescribe to adolescent and adult patients hospitalized with COVID-19, as appropriate, when a clinical trial is not available or feasible. The EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions. The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states.
  • On March 29, 2020, the FDA issued an immediately in effect guidance that outlines an enforcement policy to help expand the availability and capability of sterilizers, disinfectant devices and air purifiers. The devices include those intended to make devices sterile, kill pathogens or other microorganisms and kill pathogens or microorganisms in the air. This policy reflects FDA’s commitment to ease burdens on health care providers and facilities as they face COVID-19.
  • The FDA amended the Emergency Use Authorization (EUA) for the Battelle Decontamination System for use in decontaminating compatible N95 respirators for reuse by health care personnel during the COVID-19 pandemic. This EUA is an important step forward in helping to reduce shortages in critical N95 respirators, by allowing for these important devices, when decontaminated, to be reused by medical professionals on the front lines of the COVID-19 pandemic.
  • On March 30, 2020, the FDA issued an immediately in effect guidance to help expand the availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon’s and patient examination gloves during this public health emergency.
  • FDA and FTC issued warning letters to two companies for selling unapproved products claiming to mitigate, prevent, treat, diagnose or cure COVID-19. One of the companies, Corona-cure.com, was warned for selling the product Coronavirus Infection Prevention Nasal Spray with misleading claims on its website that its product is safe and/or effective for the treatment or prevention of COVID-19. The agencies also warned Carahealth for selling its herbal products, including “Carahealth Immune,” with misleading claims of prevention and/or treatment of COVID-19. We are particularly concerned that unapproved drugs that claim to cure, treat, or prevent serious conditions may cause consumers to delay or stop appropriate medical treatment, leading to serious or life-threatening harm. There is currently no approved treatment or preventative measure for COVID-19. FDA and FTC are closely monitoring social media, the online marketplace, and incoming reports for fraudulent COVID-19 products on the market.
  • The FDA issued an updated guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding questions and answers on this subject. We plan to update this appendix as new questions arise. This guidance is intended for industry, investigators and institutional review boards and was issued because we recognize that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products.
  • Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 230 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 20 emergency use authorizations have been issued for diagnostic tests, including Abbott Diagnostics Scarborough, Inc., ID NOW COVID-19, a rapid (13 minutes or less) test. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:

Neil Tween Appointed CFO of Owlstone Medical

Owlstone Medical is in the unique position of establishing a new diagnostic modality in breath that has substantial advantages over blood as a core sample type for clinicians and for academic and pharmaceutical researchers for the early detection of disease and to enable precision medicine approaches to patient care.

Over the coming period the focus of the business is on execution, building on commercial success with major clients for additional deals and repeat business, launching innovative breath tests to the market in areas of high clinical need with large market opportunities, and supporting growth ambitions by deepening internal systems and infrastructure and securing sufficient financing to enable the potential of Breath Biopsy to be realized.

Neil Tween joins Owlstone Medical from GW Pharmaceuticals, a publicly listed (NASDAQ: GWPH) pharmaceutical company, where he served as Vice President and Group Financial Controller. During his tenure, Neil helped oversee the maturation of the company from a medium-sized UK-listed partner-funded R&D company to a 900-person global commercial organisation. Over this period, he demonstrated broad knowledge of international financial reporting standards and SEC compliance, was significantly involved in over $1 billion of public markets fundraising, and built the finance teams and systems needed to support the rapid growth of the business.

Prior to this, Neil Tween acted as Financial Controller at Jagex Ltd., and spent six years with Deloitte, advising a range of listed and private biotech and pharmaceutical clients. Neil is a chartered accountant and is a Fellow of the Institute of the Accountants in England and Wales (ICAEW).

Neil Tween, CFO at Owlstone Medical, commented: “I am delighted to be joining Owlstone Medical at this exciting time and look forward to contributing to the growth of the business as it pursues its important mission to save over 100,000 lives and $1.5 billion in healthcare costs.”

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Neil is an excellent addition to the world-class team we have built at Owlstone Medical to realize the potential of Breath Biopsy in a wide range of applications including oncology and liver disease.” He continued: “He brings the experience and financial discipline that will see us through this important next phase of growth, and I and the Board welcome him to the team.”

FDA Expedites Review of Diagnostic Tests to Combat COVID-19

The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic.

Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. Moreover, as in previous emergencies, the FDA has been extremely proactive and supportive of test development by all comers—laboratories, and large and small commercial manufacturers—offering our expertise and support to speed development and to quickly authorize tests that the science supports.

It is not the FDA’s role to develop tests or decide what tests a health care professional uses. Our role is to determine if the tests developed by others provide accurate and reliable results, even when some would prefer that we let tests on the market without evidence that they work. It’s critical that the tests used work. False results can also contribute to the spread of COVID-19. We want our treatments to be tested for effectiveness and reviewed by the FDA. We want the same for our tests—assurances that they are accurate and effective.

Developing a test:

  • Typically, with an emerging health threat, the Centers for Disease Control and Prevention (CDC) is the first developer of a diagnostic test in the U.S.
  • Samples of the virus are crucial to confirming the accuracy of the test.
  • CDC has first access to viral samples that other test developers do not. CDC also manufactures their own tests for distribution to their national network of public health labs. In this pandemic, CDC encountered problems manufacturing their test. FDA assisted CDC in their work to resolve the issue and utilize a commercial manufacturer to make tests for any laboratory, not only public health labs.
  • Viral samples became commercially available to private sector test developers in later February, when the National Institutes of Health’s partner BEI Resources began selling vials of the virus grown from material provided by CDC.
  • Laboratories have always had the ability to develop their own tests in the U.S.; the COVID-19 outbreak did not change this. Once a developer has a viral sample, they can confirm the accuracy of their test very quickly, usually in two to three days.
  • In the future, making viral samples available earlier to commercial developers will be crucial to deploying tests quickly. Moreover, CDC’s test should be manufactured by a commercial entity with the requisite expertise.

Timeline of FDA support for test developers:

  • Since the beginning of January, the FDA has worked with more than 230 test developers who have or are expected to submit requests for FDA emergency authorization of their tests; to date, 20 authorizations have been granted.
  • In addition, more than 110 laboratories have notified the FDA that they have begun using their own tests.
  • For interested developers, the FDA provided recommendations for how to check a test for accuracy as well as a short form to make it easy to share their test information quickly in support of an Emergency Use Authorization (EUA).

Emergency Use Authorization authorities:

  • An EUA, put into place by Congress, is a relaxed standard that allows tests to be made available based on less data than in non-urgent circumstances and allows for expedited FDA review.
  • In many cases, the FDA can do this review in as little as a day, which it has done repeatedly.
  • EUA authority is not a barrier to test availability.

FDA policy updates:

  • The FDA recognized the urgent need for even faster testing availability. Although laboratories could use the EUA pathway, many were hesitant or didn’t know the pathway was available to them.
  • To respond to this need, the FDA revised the process to allow labs to begin testing prior to FDA review of their validation data. This policy change was an unprecedented action to expand access to testing. Nevertheless, in the first week, only six laboratories took advantage of this further streamlined process because many laboratories did not have a test, or did not have the viral samples to check the accuracy of their test.
  • In addition, the FDA implemented another change to empower states to take responsibility for tests developed and used by laboratories in their states without FDA review.

The FDA has and will continue to play a pivotal role in this emergency response.

Reprocessing N95 Masks With STERRAD: Protects Healthcare Workers in the Battle Against COVID-19

Advanced Sterilization Products has qualified a new reprocessing protocol that can extend the lifespan of single-use N95 masks (respirators) utilizing STERRAD® Systems already available in most US hospitals and globally.

The evolution of the COVID-19 pandemic has created a mass shortage of N95 masks for healthcare professionals around the world. ASP qualified a protocol for reprocessing select N95 masks so hospitals can triple the lifespan of the mask using the STERRAD® Sterilizers already in healthcare facilities today to reprocess up to 480 masks per STERRAD® Sterilizer machine daily to help healthcare professionals combat the spread of coronavirus.

“We are a company dedicated to keeping people safe, so we are proud to bring forth this new protocol to help extend the functionality of mission-essential N95 masks at this critical time,” said Dominic Ivankovich, President of ASP. “We are committed to provide support to the medical community and continue to work closely with them to implement this new protocol to help keep our HCP heroes safer as they remain at the front-lines in the battle against COVID-19.”

All ASP sterilization systems and disinfectant solutions have been tested against enveloped viruses, the family of viruses that includes coronavirus, and have been demonstrated to be efficacious against those viruses. ASP’s new qualified protocol uses technology already in place in most hospitals to now reprocess certain N95 masks.

“ASP feels responsible to help discover solutions that will aid frontline responders to remain safe in fighting back this pandemic,” said Jeremy Yarwood, Vice President Research & Development, ASP. “The new FDA guidance has allowed us go public with our qualified solution quickly so we can join the effort to overcome shortages of personal protection equipment for healthcare workers worldwide.”

Visit asp.com for complete and up-to-date information on PPE reprocessing, instructions for use of the N95 reprocessing protocol, and 8 Things to consider before reprocessing N95 masks/respirators.

Fractyl Laboratories Announces New REVITA-2 Study Clinical Data

Fractyl Laboratories Inc. today announced clinical data that elucidate the mechanisms behind the beneficial effects and significant improvements in metabolic disease parameters for type 2 diabetes patients after one Revita® duodenal mucosal resurfacing (DMR) treatment.

The data, including results from a mixed meal tolerance test, was accepted for presentation at the Endocrine Society’s annual meeting, ENDO 2020 (canceled due to the COVID-19 pandemic) and will be published in a special supplemental section of the Journal of the Endocrine Society. This clinical data was featured as a “Breakthrough in Diabetes” at today’s webcast news conference hosted by the Endocrine Society.

Previous results from the REVITA-2 study, a randomized, sham-controlled clinical trial, presented at AASLD 2019 and recognized there as ‘Best of the Liver 2019,’ have shown that Revita treatment lowers blood glucose (HbA1c) and reduces liver fat in patients with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD) compared to a sham procedure. For the sham, the Revita catheter was inserted into the intestine but no treatment was performed. All patients underwent a graduated diet for two weeks after the intervention per protocol. Neither the patients nor the endocrinologist knew which treatment the patients received.

As part of the REVITA-2 study, 70 patients with inadequately controlled type 2 diabetes on oral anti-diabetic medications (OADs) also took part in an additional evaluation called the mixed meal tolerance test (MMTT), which helps determine insulin sensitivity and pancreatic beta cell function. The MMTT was performed at baseline and three months after treatment in these patients. Compared with those receiving a sham procedure, patients who received the Revita treatment had significantly lowered glucose levels, primarily driven by decreased fasting blood glucose levels. The average fasting glucose level fell by 41 mg/dL in the Revita-treated group, whereas in the sham group, it only dropped by 15 mg/dL. Improvements in insulin sensitivity and pancreatic beta-cell responsiveness to a meal were also observed in patients who received the Revita treatment compared to those that received the sham treatment.

David Hopkins, MB.Ch.B. (M.D.), director of the Institute of Diabetes, Endocrinology and Obesity, King’s Health Partners in London, the U.K. and REVITA-2 study investigator, said, “This data verifies the gut’s critical role as a root cause of metabolic disease and as an important therapeutic target for type 2 diabetes. Revita leverages many of the benefits of bariatric surgery on glucose metabolism but as a minimally-invasive, outpatient procedure, it is a potential solution for millions of patients. With these data, we show that Revita can change the trajectory of disease by addressing the underlying insulin resistance that causes the progressive failure of the pancreatic beta cells. It’s a major step forward in the development of a disease-modifying treatment for type 2 diabetes.”

David Ehrmann, Professor of Medicine, University of Chicago, and a member of the Writing Committee for the Restoring Insulin Secretion (RISE) study, commented, “From the RISE study, it was disappointing to see that none of the drugs currently approved to treat type 2 diabetes could reverse pancreatic beta-cell failure and, thus, could not stop disease progression. RISE results raise the question as to whether currently available pharmacologic agents will be able to fundamentally alter the trajectory of metabolic disease. These data from a completely innovative, minimally-invasive treatment provide hope that we will have the capability to help our patients improve and possibly mitigate the complications of diabetes instead of managing its symptoms with medications.”

Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl Laboratories, said, “The data from the REVITA-2 clinical study presented here builds on what we previously presented this past November at AASLD to show that one Revita treatment in the gut can improve the health and function of both the pancreas and the liver. It further confirms that by intervening in gut biology we can reverse both progressive beta-cell deterioration and insulin resistance, which has implications for treating a number of metabolic diseases. Now, across hundreds of patients and several clinical studies in patients who have received Revita treatment, we have seen consistent and significant efficacy with an excellent safety profile. With two-year durability data, and now confirmation that Revita DMR is a disease-modifying therapy that can reverse insulin resistance, we are in a prime position to initiate our U.S. pivotal trial and accelerate global commercialization.”

Reference

JAMA Internal Medicine, August 2019, doi:10.1001/jamainternmed.2019.2396

FDA Approves Next-Generation ZOLL TherOx System for Widowmaker Heart Attack Patients

ZOLL® Medical Corporation announced today it has received U.S. Food and Drug Administration (FDA) approval of the second-generation TherOx System, which provides SuperSaturated Oxygen (SSO2) Therapy and reduces heart muscle damage in “widowmaker” heart attack patients.1

“The TherOx SSO2 Therapy system is another example of ZOLL’s commitment to technology that provides advanced clinical performance to improve outcomes,” said Neil Johnston, President, ZOLL Circulation. “We are pleased to provide the interventional cardiologist with a new treatment that augments the standard of care for patients.”

SSO2 Therapy delivers hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularization via angioplasty and stenting of the blocked coronary artery. It is indicated for patients who suffer the most serious kind of heart attack — left anterior descending ST-elevation myocardial infarction (LAD STEMI), also known as a “widowmaker” due to the high mortality rate — and who are treated within six hours of symptom onset. SSO2 Therapy is the first and only FDA-approved treatment beyond percutaneous coronary intervention (PCI) to reduce muscle damage in heart attack patients.2

“SSO2 Therapy is the only point-of-care treatment for LAD STEMI patients which results in a predictable reduction in infarct size and improved left ventricular function1,5” said Richard A. Schatz, MD, Research Director, Cardiovascular Interventions, at Scripps Memorial Hospital in La Jolla, CA. “This can translate to heart failure prevention and patient survival.”

Historically, angioplasty and stenting have been the standard of care in treating heart attacks. Many patients do not achieve maximum clinical benefit and suffer from reduced heart function. More than 30% of severe heart attack patients develop heart failure,3 and of those, 50% will die within five years.3 SSO2 Therapy has been shown in prospective clinical trials to safely reduce infarct size in “widowmaker” heart attack patients5. Decades of research on heart attack patients has demonstrated that infarct size reduction is correlated with reduced mortality and heart failure, and better left ventricular function.4

References

1Stone GW, et al. Circ Cardiovasc Intervent 2009;2:5:366–375.
2Martin JL. Cardiac Interventions Today. 2019;13:4:28–30.
3Heart Failure Fact Sheet|Data & Statistics|DHDSP|CDC
4Stone, G.W. et al. J Am Coll Cardiol. 2016;67(14):1674–83.
5David SW, et al. Catheter Cardiovasc Interv. 2018;1–9.

INVU Remote Pregnancy Monitoring System Receives FDA Clearance

Nuvo Group is a private company with a bold ambition to reinvent pregnancy care for the 21st century. Today the company announced that it has received clearance from the U.S. Food & Drug Administration (“FDA”) to market INVU™, a prescription-initiated, protocol-driven remote monitoring platform that offers measurements of fetal and maternal heart rate via a wireless, self-administered INVU sensor band. Now, healthcare providers can offer a novel site for distributed pregnancy care—the mother’s location—to remotely obtain documentation of medical-grade fetal heart rate (FHR) and maternal heart rate (MHR).

The INVU platform will be available by prescription from a healthcare provider who will initiate and schedule remote monitoring sessions.  INVU non-invasively measures and displays FHR and MHR tracings via a self-administered, wearable sensor band worn by the mother which passively collects multiple sources of physiological signals. During the reading, the mother can access personalized insights via a smartphone app, while her provider receives detailed data on maternal and fetal heart rate over time. INVU is indicated for use by pregnant women who need documentation of fetal heart rate activity, and who are in their 32nd week of gestation (or later), with a singleton pregnancy.

“Nuvo was founded to provide 21st-century technology and tools that enable distributed pregnancy care. Meeting 510(k) requirements has been an important part of the mission to ensure that we are delivering safe and effective prenatal monitoring solutions remotely,” said Oren Oz, Founder, and Chief Executive Officer, Nuvo Group. “Now more than ever, distance health solutions like INVU are needed to minimize pregnant women’s exposure to crowded offices and infectious hospitals settings.”

Joshua Copel, MD, chair of Nuvo’s Medical Advisory Board, and Professor, Obstetrics, Gynecology & Reproductive Sciences, and Pediatrics, Yale School of Medicine, said, “Offering pregnant women new and more convenient ways to connect with OB providers can increase access to specialty care, enhance the patient experience in a way that is safe, cost-effective and risk-appropriate, and—importantly during the current COVID-19 pandemic–minimize unnecessary exposure.”

Medtronic Evolut TAVR System Demonstrates Excellent Outcomes in Study of Low-Risk Patients with Bicuspid Aortic Stenosis

March 29, 2020

Medtronic Evolut TAVR System late-breaking clinical data from the Low-Risk Bicuspid Study assessing the use of the Evolut™ transcatheter aortic valve replacement (TAVR) system in patients with bicuspid aortic valve stenosis at low surgical risk was presented.

The Medtronic Evoult TAVR System study showed low rates of all-cause mortality or stroke at 30 days (1.3%) with a low rate of serious procedural complications, and no annular rupture or aortic dissection. The study was presented as part of the American College of Cardiology together with World Congress of Cardiology Scientific Sessions (ACC.20/WCC) meeting.

Results from the 150-patient, single-arm study showed excellent outcomes at 30 days, with a 95.3% device success rate and a low rate of serious procedural complications including no annular ruptures or aortic dissection. In addition, results from the study showed:

  •  Low rate of all-cause mortality (0.7%)
  •  Low rate of disabling stroke (0.7%)
  •  Exceptional hemodynamics with low mean AV gradients (7.6 ± 3.7 mm Hg), and large effective orifice area (2.3 ± 0.7 cm2)
  •  No incidence of moderate or severe paravalvular leak (PVL)
  •  Low rate of major vascular complications (1.3%)
  •  High utilization of the Evolut 34 mm (41.6% of patients in the study were implanted with this larger valve size)
  •  New pacemaker rate (15.1%) was lower than in the Evolut Low Risk Trial

“These findings point to a potentially less invasive treatment for patients who otherwise would undergo open-heart surgery due to their anatomical valve structure,” said Basel Ramlawi, M.D., chair of The Heart & Vascular Center at FACC Valley Health System in Winchester, Va., and co-primary investigator of the study who presented the data at the meeting. “We feel confident that these primary early outcomes provide additional evidence that the Medtronic Evoult TAVR System is a suitable treatment option for patients with bicuspid valves who have previously been left out of TAVR trials.”

Aortic stenosis (AS) is one of the most common valvular heart diseases in the world1, affecting 1.5 million individuals2. Bicuspid aortic valve disease (BAVD) is a congenital heart defect affecting approximately two percent of the general population and is an abnormality of the aortic valve resulting in the patient having two functional valve leaflets instead of the more common three leaflets (tricuspid). Often younger than tricuspid AS patients (median age of 70 in the study), patients with BAVD were generally excluded from prior TAVR trials due to concerns of asymmetric calcification, elliptical shape, potential incomplete valve expansion, procedural technical concerns and other risk factors. In 2018, Medtronic received U.S. Food and Drug Administration (FDA) approval for revised commercial labeling for the Evolut TAVR system that removed a precaution for the treatment of bicuspid severe AS patients deemed at intermediate or greater risk for surgical aortic valve replacement. It is estimated that approximately 60% of the low risk TAVR patient population have BAVD. The Evolut TAVR system is not currently approved in any geography for use in patients with bicuspid aortic valve stenosis at low surgical risk.

“Evidence continues to support the use of TAVR with the Evolut platform in groups of patients previously thought to be more challenging, or non-candidates for the procedures. In addition to reaffirming the Evolut valve’s exceptionally strong hemodynamic, today’s data indicate that low-risk bicuspid aortic stenosis patients implanted with TAVR do very well,” said Pieter Kappetein, M.D., vice president, medical affairs for the Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic. “We’ve observed the Evolut TAVR valve to be a suitable treatment option for many patients with bicuspid aortic valve disease at intermediate risk or higher, and these data are encouraging that we may see a similar outcome in low-risk patients.”

Medtronic is a leading innovator of heart valve therapies, including the first transcatheter pulmonic valve, the first self-expanding and recapturable transcatheter aortic valve, and the first transcatheter mitral valve replacement technology to be studied in a global pivotal trial. The Evolut TAVR platform – including the Evolut™ R, Evolut™ PRO and Evolut PRO+ TAVR Systems – is indicated for symptomatic severe AS patients across all risk categories (extreme, high, intermediate and low) in the U.S. Bicuspid valve patients at intermediate risk or higher may be candidates for TAVR in the U.S.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

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