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American College of Cardiology Urges Heart Attack, Stroke Patients to Seek Medical Help

Through its CardioSmart patient initiative, the American College of Cardiology has issued guidance to encourage patients experiencing a heart attack or stroke to call 911.  While hospitals across the United States are experiencing an influx of COVID-19 patients, clinicians are reportedly seeing fewer patients going to emergency rooms for heart attack or stroke. Experts worry that patients who need critical care are delaying their treatment over concerns about the novel coronavirus.

“Due to fears of contracting COVID-19 or taking up space in hospitals, patients experiencing a heart attack or stroke are delaying their essential care, causing a new public health crisis,” said Martha Gulati, MD, FACC, editor-in-chief of CardioSmart.org. “Hospitals and catheterization labs are still treating heart attack and stroke, not just COVID-19, and are taking the utmost precautions to ensure that the novel coronavirus not be spread. The faster a patient is treated, the higher the outcome of survival and lower the risk for complications. No patient should delay their care.”

A new CardioSmart infographic, “Coronavirus and Your Heart: Don’t Ignore Heart Symptoms,” encourages patients to pay close attention to heart attack or stroke symptoms, particularly if they have a pre-existing heart condition, and call 911 immediately if they believe they’re having a heart attack or stroke. The infographic details common heart attack and stroke symptoms and ensures hospitals are taking steps to protect them from COVID-19. The infographic also encourages patients to continue routine heart care to ensure they stay healthy, which may be accomplished through telehealth (remote or virtual visit) or a phone call with their clinician.

“We encourage clinicians to widely distribute these tools to their patients. Make sure that patients know when telehealth is an appropriate option, and when they should call 911 instead,” Gulati said. “Clinicians should work with patients to ensure medication adherence, and always continue to advocate for heart-healthy measures that can be taken even in times of self-isolation and social distancing.”

CardioSmart serves as the ACC’s patient engagement initiative. Reviewed by experts in the CardioSmart COVID-19 Response Work Group, the new infographic joins the full collection of ACC COVID-19 resources, including clinical bulletins, journal articles, patient summaries and more. For more information about how COVID-19 affects patients with pre-existing heart conditions, and to download the full infographic, visit the CardioSmart COVID-19 Hub.

Tack Endovascular System® Receives FDA Approval for Below-the-Knee Post-Angioplasty Dissection Repair

April 14, 2020

Tack Endovascular System (4F), a novel, minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries has received U.S. Food and Drug Administration approval reports Intact Vascular, Inc.

Regulatory approval was based on data from Intact Vascular’s Tack Optimized Balloon Angioplasty II BTK (TOBA II BTK) clinical trial, notably the first study to enroll patients with advanced disease below-the-knee and 100% dissected vessels. The TOBA II BTK study enrolled patients suffering from critical limb ischemia (CLI), a condition associated with high rates of amputation and mortality.1 Data from the trial was presented in a late-breaking scientific session at the 2019 VIVA conference.

“Patients who have progressed to a CLI diagnosis frequently endure debilitating pain, even at rest, infected foot ulcers, and are at an increased risk for amputation,” commented George Adams, M.D., M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital, Raleigh, North Carolina and Co-Principal Investigator of the TOBA II BTK trial. “This is a complex patient population that historically had limited treatment options. The Tack implants deliver a much-needed solution that effectively restores blood flow, promotes healing and preserves limbs.”

The prospective, multicenter, single-arm TOBA II BTK study met all primary endpoints with 100% acute dissection resolution and 73.8% of wounds healed or improved at six months. Results demonstrated 95.7% K-M amputation-free survival, 87.3% K-M target lesion patency with significant improvement in toe-brachial index (TBI) and 92.0% K-M freedom from clinically driven reintervention.

Additional Co-Principal Investigators for the trial included Patrick Geraghty, M.D., Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri, and Andrej Schmidt, M.D., Division of Interventional Angiology, University Hospital Leipzig, Germany.

“The TOBA II BTK trial was very well-designed and the first to investigate a permanent vascular implant for treatment of post-angioplasty dissections in small vessels,” stated Dr. Geraghty. “FDA approval of the Tack (4F) implant marks a significant advancement in treatment of CLI, and I am pleased to have this pioneering technology available going forward.”

“We are thrilled to have the first peripheral vascular implant approved in the U.S for below-the-knee interventions,” remarked Bruce Shook, Intact Vascular’s President and CEO. “We will be working closely with our customers to implement a careful introduction of the Tack (4F) implant to those centers with the most pronounced need during this unprecedented time of stress on our healthcare system.”

Nathan Diers Promoted Vice President of EyeKor Product Development

Effective immediately, EyeKor Inc. announced they are promoting Nathan Diers to the role of Vice President of Product Development, leading the development efforts for EXCELSIORTM, EyeKor’s cloud-based, FDA 510(k) cleared, clinical trial image management and analysis software.

Nathan Diers brings 15+ years of research experience in the field of clinical trial management and has been serving as a vital part of EyeKor’s evolution and success since its inception. Over the past five years, Diers has served EyeKor as the Senior Director of Operations. In his new role, Diers will expand his work with study sponsors and central reading centers to develop trial-specific imaging protocols and grading schemes, lead the software development and validation team, and improve the EXCELSIOR™ platform functionality to meet the expanding user needs beyond the field of ophthalmology.

Yijun Huang, CEO of EyeKor, is thrilled with this new promotion. Huang said, “Nathan has been an integral part of EyeKor’s growth. His ability to service EyeKor’s clients and guide the development of our EXCELSIOR™ software makes him an ideal candidate for this position.  We are very excited to welcome Nathan to the executive team.”

Charlie Alvarez Appointed Alliance Family of Companies CEO

Charlie Alvarez has been appointed the new Chief Executive Officer of Alliance Family of Companies, effective immediately. Charlie Alvarez brings more than 30 years of healthcare leadership experience and most recently served as Chief Executive Officer of DCI Health Technologies, Inc.

Charlie Alvarez succeeds J. Randall Keene, who has served as interim CEO since June 2019. Keene will continue in his role as Chairman of the Alliance Board of Directors.

In making the announcement, Keene cited Alvarez’s extensive strategic experience and entrepreneurial track record. “Charlie is the right leader for this role, especially in the current environment,” said Keene. “After an extensive search, Charlie presented the perfect blend of industry experience and executive leadership to carry Alliance into the future. He also comes to the company with a strong belief in our core values, which are to provide the best solutions for the patient, provider, and payor. I am confident he will continue to drive Alliance’s focus on value-based healthcare delivery by providing accessible, high-quality neurodiagnostic services in the home, as these services shift out of the hospital setting.”

As Chief Executive Officer of Foxconn’s DCI Health Technology, Inc., a multinational health technology company, Alvarez was responsible for launching the company in the United States and driving its revenue and profitability growth. He joined DCI in 2017, when his previous company, Sotera Wireless Inc. was acquired by Foxconn. Alvarez had joined Sotera Wireless in 2014 as Senior Vice President of Sales and Marketing where he was responsible for growing sales and revenue. Sotera is a medical device company that specializes in body worn vital signs monitoring. Within two years, Alvarez grew the client base from seven hospitals to more than 55 and grew revenue by more than 75 percent, year-over-year.

Prior to Sotera, Alvarez was President and Co-Founder of Watermark Medical, a privately held sleep diagnostics and therapy company. Alvarez was President through the acquisition of SleepMed, Inc, in 2012, a company that also provided EEG services. At Watermark, Charlie pioneered the home sleep testing market and grew the company to become the market leader in five short years. Before co-founding Watermark, Alvarez held various leadership positions at CardioNet (Biotel), the world’s largest remote cardiac monitoring company and PSS/World Medical, now McKesson.

“I’m excited to be joining the Alliance team,” said Alvarez. “I believe Alliance has a great business model, high-quality services and a robust R&D pipeline to position it for high growth over the next several years. I look forward to applying my experience in the ever-changing medical marketplace to lead the company in the development of technology and services that help provide better healthcare solutions. Alliance is poised for hyper-growth as we prepare for the upturn in business as this crisis starts to wane.”

HeartStation Selects iBASIS eSIM for Remote Monitoring of AEDs to Ensure They Are Fully Powered and Operational in the Event of an Emergency

Today iBASIS, a provider of communications solutions for operators and digital players worldwide, announced that HeartStation, a global manufacturer of Automated External Defibrillator (AED) cabinets and accessibility products, has selected iBASIS eSIM for remote monitoring of AEDs to ensure they are fully powered and operational in the event of an emergency.

iBASIS’ selection follows one of the fastest implementations of its IoT solution to date, with field trials completed in just five days in late December 2019 and solution installed as of January 2020.

As the U.S. National Safety Council reports, greater access to AEDs could save 40,000 lives each year in the U.S. alone, and access to fully powered AEDs by bystanders can increase the odds of survival up to 40% and higher.1 The iBASIS eSIM enables dynamic monitoring of AEDs via an eSIM card installed within the AED cabinet. A signal is regularly monitored during the AED self-test, with automatic alerts to dispatch a technician should the device not meet the necessary operation.

Over 50,000 HeartStation AED units will be globally, remotely monitored via the iBASIS eSIM. The iBASIS solution is differentiated in its ability to enable dynamic routing selection of communications carrier in the cloud to drive the most effective network connectivity to remotely monitor and manage devices worldwide.

“The iBASIS eSIM is the perfect solution to further enhance the effectiveness of critical public access defibrillation programs by enabling remote monitoring of AEDs,” says Keith Hochhalter, President, HeartStation. “This solution ensures that devices will be fully available in critical circumstances, and we are very proud to partner with a company that shares our commitment to delivering life-changing innovation and performance.”

“HeartStation has developed unsurpassed capabilities for enhancing access to lifesaving devices,” says Ajay CTO, iBASIS. “We are extremely pleased to partner with them to deliver the remote monitoring needed to ensure their devices are always powered. We are also very happy with the incredible speed with which the teams have implemented the iBASIS eSIM capability. Our work with HeartStation reflects our commitment to enabling companies around the world to rapidly achieve the highest performance in management and monitoring of their products globally.”

Reference

1 Source: US National Safety Council

54gene Closes $15M Series A

54gene, the African genomics research, services, and development company has closed a Series A round of $15M, led by Adjuvant Capital, a life sciences fund backed by the International Finance Corporation, Novartis, and the Bill & Melinda Gates Foundation.

54gene notes the round included participation from Raba Capital, V8 Capital, Ingressive Capital, and follow on investment from Y Combinator, Better Ventures, Fifty Years, KdT Ventures, Aera VC and Pioneer Fund. In July 2019, 54gene secured a Seed round of $4.5M which brings the company’s total VC investment to $19.5M.

The investment secured today will allow the company to scale operations in support of generating novel insights from human genetics research that result in high impact discoveries for improving human health through therapeutic development. The investment will also be used to accelerate discovery capabilities by bolstering operations in genetics, bioinformatics, preclinical, clinical and commercial programs.

54gene was launched in January 2019, to address the significant gap the genomics market currently poses for Africa, and build and use African genetic data sets to make landmark discoveries to support therapeutic development. As of 2018, less than 3% of the data used in Genome-wide Association Studies [GWAS] were of African ancestry and currently, less than 1% of global drug discovery occurs on the African continent. Located in Africa’s most populous country, Nigeria, and in the US, 54gene aims to improve the development, availability, and efficacy of medical products that will prove beneficial to Africans and the wider global population.

As part of its next stage of growth, the company will further explore partnerships and opportunities for co-development of drug targets and therapeutics and expects to partner with pharmaceutical, medical device and diagnostic companies for clinical programs in Africa, which will be led by 54gene’s newly appointed Vice President of Clinical & Regulatory Affairs, Kemi Williams, who was formerly Head of Clinical Affairs for Siemens Healthineers US molecular diagnostics business, and previously worked at Roche, Abbott, and Medtronic.

In addition to its Series A raise, 54gene is also announcing the formation of its Scientific Advisory Board [SAB]. The SAB is composed of global leaders in clinical genetics, bioinformatics and data science;  Michael F. Murray MD, Director of Clinical Operations, Center for Genomic Health Professor Dept of Genetics, Yale School of Medicine, Manuel Rivas PhD, Assistant Professor at Stanford University, Greg Hinkle Ph.D., VP Research Informatics, Alnylam Pharmaceuticals and Jeff Hammerbacher, Founder and General Partner, Related Sciences.

Speaking on today’s news, 54gene Founder and CEO Dr. Abasi Ene-Obong says, “This new partnership marks a significant evolution in the growth of our company. In the coming months we will be focusing on building a genomic resource that we hope will add significantly to global health, while also translating to the health benefits of patients in Africa. We will also be expanding our collaborations in Africa with both public and private stakeholders and investing in setting up a state-of-the-art research lab with high-throughput genetic processing and BSL 3 capabilities in Nigeria, and ensuring that we build some of our innovative pipelines on the African continent.”

54gene currently works with 300+ researchers, clinicians and geneticists across the continent, to improve the global collective knowledge of genomic determinants of health and to facilitate translational research. The company has also built an African Biobank, a state-of-the-art biorepository that stores biological samples to provide access to aggregated, de-identified data and bio-specimen mainly for secondary use by researchers, to support both academic and development research.

Jenny Yip, Managing Partner of Adjuvant Capital adds, “There is enormous potential in expanding the reach of global drug and vaccine discovery by including more diverse populations in research efforts. We were impressed by 54gene’s commitment to building a world-class network of African clinicians and geneticists and are excited to work with them as they scale and seek to drive meaningful improvements in global public health.”

Dr. Ene-Obong concludes, “This funding comes at a historically meaningful time, allowing us to deliver global impact through continued investment in research and strategic partnerships with leaders in the biomedical industry. We want to support the crucial work of our partners in Africa while improving global health and are committed to promoting a safe, ethical and beneficial research practice.”

FDA COVID-19 Update

The FDA announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available for patients:
    • Today, the FDA published product-specific guidances (PSGs) to support generic drug development for these drugs. The new PSG for chloroquine phosphate clarifies that the product is AA rated in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), meaning that there are no known or suspected bioequivalence problems, and no in vivo studies are necessary. The revised PSG for hydroxychloroquine sulfate adds advice about a Biopharmaceutics Classification System-based biowaiver option.
    • The FDA is currently prioritizing review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate under MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments, and Supplements.
  • The FDA added new questions and answers to the webpage Q&A for Consumers: Hand Sanitizers and COVID-19. These new questions focus on unintentional ingestion of hand sanitizer by children, as there has been an increase in calls to Poison Control for unintentional ingestion of hand sanitizer during the COVID-19 pandemic.
  • The FDA issued an Emergency Use Authorization (EUA) for the emergency use of the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES (“B. Braun Space and Outlook Pumps”) for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and decrease the exposure of healthcare providers to such patients during the COVID-19 pandemic. The EUA was also issued for ground medical transport use of the Infusomat Space Volumetric Infusion Pump System.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
    • To date, 34 emergency use authorizations have been issued for diagnostic tests.
    • The FDA has been notified that more than 180 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:

Expert Medical Societies Release Multidisciplinary Recommendations for Breast Cancer Patient Care During COVID-19 Pandemic

The American Society of Breast Surgeons (ASBrS), the National Accreditation Program for Breast Centers (NAPBC), the National Comprehensive Cancer Network (NCCN), the Commission on Cancer (CoC) of the American College of Surgeons, and the American College of Radiology® (ACR®) have released new joint recommendations for prioritization, treatment and triage of breast cancer patients during the coronavirus (COVID-19) pandemic.

“As hospital resources and staff become limited, it is vital to define which breast cancer patients require urgent care and which can have delayed or alternative treatment without changing survival or risking exposure to the virus,” said Jill R. Dietz, MD, FACS, president of the ASBrS.

“The COVID-19 pandemic presents unprecedented challenges. These guidelines can help modify patient care to minimize exposure risk and preserve resources for patients with the most immediate need for care,” said Lawrence N. Shulman, MD, chair of the CoC.

The new recommendations categorize these patients into priority levels (A, B, C) for urgency of care across all specialties and provide treatment recommendations for each category.

  • Priority A patients have conditions that are immediately life-threatening or symptomatic, requiring urgent treatment
  • Priority B patients have conditions that do not require immediate treatment but should start treatment before the pandemic is over
  • Priority C patients have conditions for which treatment can be safely deferred until the pandemic is over

“Implementation of these recommendations, based on the highest level of available evidence, must be adapted to current resource availability and COVID-19 pandemic severity in that region,” said Scott H. Kurtzman, MD, FACS, chair of the NAPBC.

Doctors should use the recommendations to prioritize care for these patients and adapt treatment recommendations to the local context at their hospital,” said William J. Gradishar, MD, chair of the NCCN breast cancer panel.

Access the new joint breast cancer patient care recommendations here.

Note: These new recommendations are presented in an article entitled, “Recommendations for Prioritization, Treatment and Triage of Breast Cancer Patients During the COVID-19 Pandemic,” recently accepted for publication in an upcoming issue of Breast Cancer Research and Treatment, a peer-reviewed journal.  The link to the open access document will be provided when it is released.

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Alternative Therapy Treatment For COVID-19 Patients Released Reports Piranha Medical

Piranha Medical, LLC, is a medical device company with several innovative catheter solutions in the gastrointestinal, pulmonary, and pancreatic markets.  Today the company announced the release of its newest product, Piranha LC. The Piranha LC (Luminal Clearance) which is a catheter-based device that has proven to be successful in multiple procedures.

The first, an alternative methodology for the removal of mucus and lung lavage in severe COVID-19 patients. Second, the improved suction of necrotic tissue and pancreatic blood fluids for the management of necrotizing pancreatitis (NP) for Endoscopic transmural necrosectomy (ETN).

In recent weeks, the Piranha LC has provided an alternative treatment option for COVID-19 patients who require the removal of mucus and lung lavage for both testing and disease recovery purposes. COVID-19 patients have shown symptoms of coughing up sputum or thick phlegm from the lungs. Removal of this mucus is seen to be a challenge, especially with the limited resources at the disposal of physicians treating these patients. Through the use of a bronchoscope, which is an aerosol-generating procedure, poses substantial risks to the patients, staff, and doctors, where COVID-19 virus has the potential to infect others, causing the disease to spread. The Piranha LC offers a safer alternative than the current practice by enabling the deep mucus removal and lung lavage without aerosol generations using a patented filtered aspiration system, independent of a bronchoscope. This system enables a suitable intervention for ventilated patients without spreading the virus. The new use allows for the proper sampling of non-contaminated lung samples, which could not previously be performed.

Second, the Piranha LC allows for the proper suction of necrotic tissue, and pancreatic blood fluids in the catheter, leaving a field clear for proper visualization. The primary purpose of the Piranha LC device is to support the management of Necrotizing Pancreatitis (NP). Today, there are a variety of treatment techniques currently used; however, ETN procedures have begun to emerge as the preferred treatment over surgical and percutaneous treatments currently in place within this market.

Michael Augustine, CEO of Piranha Medical, indicated, “The Piranha LC comes at a pivotal moment as the healthcare industry is seeking alternative methodologies and treatments to combat the COVID-19 pandemic. It enters the market and immediately fills a critical need in the fight against the disease. It is a safer alternative in protecting our frontline workers, and ultimately help to prevent the spread of the coronavirus.”

The Piranha LC device will be available to the market, as early as April 18, 2020. The device is expected to be made available through a variety of channels, including direct purchase from Piranha Medical, or through their distribution partnership with GI Supply. Other distribution avenues, with larger medical device entities, are being considered but have not been announced at this time.

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