The Latest Cardiac and Vascular News
Study Seeks to Confirm Benefits of Cagent’s Unique Serration Balloon Angioplasty Technology vs. Plain Old Balloon Angioplasty (POBA) in treating Peripheral Artery Disease (PAD) in Below-the-Knee Arteries. WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, Inc., the exclusive developer of serration technology for vessel dilation in endovascular interventions, announced its 1st patient enrollment of the […]
Novel IVL technology designed to deliver calcium fragmentation for treatment of moderate to severely calcified coronary artery lesions without requiring an energy source. IVL technology expands company’s innovative product portfolio. MILPITAS, Calif., April 10, 2025 (GLOBE NEWSWIRE) — Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced EU MDR CE Mark approval and commercial launch of its LithiX™ Hertz Contact (HC) Intravascular Lithotripsy System (IVL) in Europe. The first cases were completed by Stefano Galli, MD, Interventional Cardiologist at Centro Cardiologico Monzino in Milan, Italy; Professor Eric Van Belle, MD, Head of the Interventional Cardiology Department, Lille University Hospital, Lille, France; and Professor Nikos Werner, MD, Hospital Barmherzigen Bruder Trier, Trier, Germany. LithiX™ lithotripsy mechanism of action to create calcium fractures is based on the Hertz Contact Stress principle and does not require an external energy source or capital equipment, delivering the expected performance of IVL with additional versatility to treat complex calcified lesions based on the unique design. “Lithotripsy, introduced in urology a few decades ago, has evolved to encompass mechanical and energy-based mechanisms of action to fragment calcium deposits while minimizing injury to soft tissue. Energy-based lithotripsy for intravascular use was adapted to deliver effective calcium modification while preventing injury to adjacent non-calcified vessel associated with manual devices,” said Motasim Sirhan, CEO of Elixir Medical. “With LithiX™, we created the first mechanical IVL platform capable of treating broad calcified lesion morphologies with great final outcomes, while minimizing injury to adjacent non-calcified vessel.” LithiX™ Hertz Contact IVL System is a transcatheter device comprised of multiple low-profile metal hemispheres uniformly distributed and integrated across the surface of a semi-compliant balloon. Under low balloon inflation pressure, the hemispheres create highly localized points of contact with calcium and amplification of force to create deep and wide fractures based on Hertz Contact Stress mechanics, while minimizing vessel injury when in contact with soft non-calcified vessel tissue. “Optimal calcium modification is very important in achieving good PCI outcomes, and LithiX Hertz Contact IVL fulfills that goal as a simple-to-use and versatile option with excellent clinical performance,” said Stefano Galli, MD, Interventional Cardiologist at Centro Cardiologico Monzino in Milan, Italy. With this unique mechanism of action, LithiX™ HC-IVL is designed to enhance and expand calcium treatment with an optimized procedure workflow in the catheterization lab, positively impacting percutaneous coronary intervention (PCI) treatment. “We are excited to adopt LithiX™ in our everyday practice as a very deliverable tool designed to safely modify calcified lesions that is easy to use with high degree of precision and control,” said Nikos Werner, MD, Hospital Barmherzigen Bruder Trier, Trier, Germany. “In our first cases, we have seen confirmation of the recent PINNACLE study outcomes with LithiX HC-IVL in treating calcified coronary lesions with a great procedural result in eccentric and concentric calcium,” added Professor Eric Van Belle, MD, Head of the Interventional Cardiology Department, Lille University Hospital, Lille, France. The company recently announced six-month data from the PINNACLE I study showcasing LithiX™ HC-IVL’s unique mechanism of action with sustained clinical outcomes. An intravascular imaging sub-study using optical coherence tomography (OCT) demonstrated effective treatment in a broad range of complex calcified lesions, including concentric and eccentric calcium and lesions with calcium nodules. Stent expansion at the Minimum Stent Area (MSA) location was 101.38%, 93.95% in eccentric and concentric lesions respectively. In lesions with calcified nodules, stent expansion at maximum calcium site was 102.81%. About the PINNACLE I Trial PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact Intravascular Lithotripsy (HC-IVL) System for the treatment of calcified lesions. The trial includes 60 patients across seven sites in Belgium and the Netherlands. An imaging subset of 32 patients underwent intravascular imaging assessment by OCT. About Elixir Medical Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025. Visit us at www.elixirmedical.com and on LinkedIn and X. The LithiX HC-IVL system is CE Mark approved. Not available for sale in the United States. Media Contact Richard LaermerRLM PRelixir@rlmpr.com(212) 741-5106 X 216
Novel all-in-one retrograde aortic access delivery system supports streamlined treatment of ventricular tachycardiaSOUTH JORDAN, Utah, April 09, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader in healthcare technology, today announced the US commercial release of its Ventrax Delivery System. The new delivery system is Merit’s latest addition to its growing electrophysiology (EP) and cardiac rhythm management (CRM) portfolio. The portfolio provides a unique selection of solutions to improve cardiac interventions, including the HeartSpan®, Worley™, Prelude SNAP™, and SafeGuard Focus® product lines. Ventrax is intended to facilitate placement of devices used in ablation procedures commonly performed to treat an abnormally fast heartbeat known as ventricular tachycardia (VT). Ventricular arrhythmias, which include VT, are believed to cause approximately three out of four sudden cardiac deaths, which result in an estimated 184,000–450,000 lives lost in the United States each year.¹ The all-in-one device provides a streamlined pathway for ablation catheters to enter the left ventricle through the aorta, an approach known as retrograde aortic access. “For the electrophysiologist, using retrograde aortic access was always a risk-benefit decision, and the community has needed a tool that would make that decision easier,” said Albert Sun, MD, electrophysiologist at Duke Health in Durham, NC, and whose advice was instrumental in Merit’s development of the Ventrax system. Retrograde aortic access can be useful to reach certain areas of the ventricle compared to traditional methods, such as transseptal puncture. Using this approach, these areas of the left ventricle are more accessible,² supporting targeted treatment. “The new retrograde delivery system provides access to the left ventricle, allowing for the exchange of catheters to diagnose, map, or treat VT,” said Jason Koontz, MD, PhD, electrophysiologist at Duke Health and product development consultant to Merit. “This adds to our tools as we work to deliver the best possible outcomes for our patients.” Learn more about the Ventrax Delivery System Key features of the Ventrax Delivery System include a 95-cm sheath designed to access desired target locations. An ultralow-profile transition between its sheath and pigtail-dilator offers smooth insertion, and an angled tip enhances the reach of an ablation catheter. VT ablation is one of the fastest growing areas in electrophysiology. Many physicians are using retrograde aortic access for VT procedures, and researchers are increasingly investigating the technique. “Effective access is essential to supporting the growth of VT ablation,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We are proud to take another significant step toward providing electrophysiologists with a valuable tool that helps fill this need in patient care.” ABOUT MERIT MEDICAL Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 700 individuals. Merit employs approximately 7,000 people worldwide. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. CONTACTSPR/Media InquiriesSarah ComstockMerit Medical+1-801-432-2864 | sarah.comstock@merit.com INVESTOR INQUIRIESMike Piccinino, CFA, IRCWestwicke – ICR+1-443-213-0509 | mike.piccinino@westwicke.com Khurshid et al. 2018. “Frequency of Cardiac Rhythm Abnormalities in a Half Million Adults.” Circ Arrhythm Electrophysiol 11 (7): e006273. (PMID: 29954742)Adlan et al. 2019. “Retrograde Aortic Access During Ventricular Tachycardia Ablation: Indications, Techniques, and Challenges.” Journal of Cardiovascular Electrophysiology 30 (11): 2629–2639. (PMID: 31502368)
Reduced hospital stays with more patients discharged to home when treated with RNS60 Results presented during oral presentation at the American Academy of Neurology 2025 Annual Meeting TACOMA, Wash., April 9, 2025 /PRNewswire/ — Revalesio, a clinical-stage pharmaceutical company…
Healthcare professionals across Canada can now access Eko’s most advanced digital stethoscope and AI-powered membership to enhance cardiac and pulmonary care. SAN FRANCISCO, April 9, 2025 /PRNewswire/ — Eko Health, a leader in applying artificial intelligence (AI) for the early detection…
Successful robotic navigation was achieved in every case and met the primary endpoint of the study
Marseille (France), April 8, 2025 – Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, today announced the appointment of Bill Hoffman as Executive Chairman of its Board of Directors. Bill brings a track record of guiding innovative startups to global success. As former Chief […]
Multi-center trial will assess safety and efficacy of ASI-02 contrast agent in cardiac bubble studies. ST. PAUL, Minn.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has cleared Agitated Solutions, Incorporated (ASI)’s Investigational New Drug (IND) application for its novel contrast agent, ASI-02, enabling the initiation of the company’s Phase 3 clinical trial. […]
DENVER, April 08, 2025 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the U.S. Food and Drug Administration (FDA) has granted SeaStar Medical two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy. The two new Breakthrough Device Designations are indicated for the treatment of systemic inflammatory response in 1) adult patients undergoing cardiac surgery and 2) pediatric patients undergoing cardiac surgery towards prevention of post-operative adverse complications and outcomes. Approximately 15 percent of the estimated 300,000 adults that undergo cardiac surgery each year are considered high risk and, we believe, could benefit most from the SCD therapy to prevent post-surgical complications. Of the 40,000 pediatric patients that undergo congenital heart surgery each year, we believe that approximately one third might benefit from SCD therapy.
