Sirolimus

MIAMI LAKES, Fla., June 18, 2024 /PRNewswire/ -- Cordis, a global leader in the development and manufacturing of interventional cardiovascular and endovascular technology, today announces positive 24-month results from the SELUTION SFA Japan Trial. The prospective, multi-center, single arm trial is designed to assess the safety and efficacy of SELUTION SLR™ Drug-Eluting Balloon (DEB) for the endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). The findings were presented at the Japan Endovascular Treatment Conference (JET) 2024. Continue Reading "The SELUTION SLR™ DEB outcomes demonstrate patient benefits that are sustained out to 24 months and can match proven paclitaxel DCB performance in a complex patient population," said Dr. Osamu Iida, Osaka Police Hospital Cardiovascular Division, Osaka, Japan. "These are promising results that build confidence in Limus drug-eluting balloons being a safe and effective option for SFA treatment while avoiding any paclitaxel related concerns." The long-term follow-up of SELUTION SLR™ DEB confirmed efficient sirolimus drug transfer and retention with safety and efficacy sustained through 24 months in a complex population that included 60.3% diabetics, mean lesion length of 127 mm, 17.2% total occlusions, and 47.8% involvement of the popliteal. At 24 months, SELUTION SLR™ DEB delivered primary patency of 83.0% and CD-TLR of 95.4% achieving best in class efficacy results without compromise. The SELUTION SFA Japan trial results demonstrate consistency of the SELUTION SLR™ DEB in being a safe and effective treatment option for femoropopliteal disease. "The SELUTION SFA Japan trial continues to build confidence in the SELUTION SLR™ DEB technology. The SELUTION SLR™ DEB delivers some of the highest patency rates amongst SFA paclitaxel DCB studies and differentiates from other Limus-based devices. The ability to achieve durable clinical results in a challenging patient population provides clinicians a solution that will offer value to real world patients," said George Adams, M.D. and Chief Medical Officer at Cordis. "We are excited for the evolution of patient care and to be leading that journey by expanding access to SELUTION SLR™ DEB." Cordis is committed to generating coronary and peripheral clinical evidence that changes the standard of care. The SELUTION SFA Japan trial is one of the first of several large trials in the SELUTION SLR™ DEB clinical trial portfolio. Long term results validate previous clinical experience and builds confidence and excitement for data to come from four major randomized controlled trials and one real world registry data sets currently underway across coronary, superficial femoral artery and below the knee arteries. About SELUTION SLR ™ DEB SELUTION SLR ™ DEB uses MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the anti-restenotic drug sirolimus, applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs are designed to provide controlled and sustained release of the drug. The proprietary CELL ADHERENT TECHNOLOGY (CAT)™ enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon. SELUTION SLR™ Drug-Eluting Balloon coronary, SFA, and BTK platforms are commercially available in Europe, the Middle East, and several markets across Asia and Latin America and most other countries where the CE mark is recognized. SELUTION SLR™ Drug-Eluting Balloon is investigational in the United States and not approved for sale or distribution. About Cordis Cordis is a global leader in the development and manufacturing of interventional cardiovascular and endovascular technologies. For over 60 years, we have remained committed to improving patients' lives through innovation, enhanced clinical outcomes, education, and service. Our mission is to relentlessly pursue our dedication to transform cardiovascular care. For more information about Cordis, please visit and follow Cordis on LinkedIn. Media Contact: Chris Bingham Vice President, Global Market & Strategy [email protected] SOURCE Cordis

Designation recognizes the novelty of the technology and the potential to provide a more effective treatment option for patients with coronary artery disease MILPITAS, Calif.--(BUSINESS WIRE)-- Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced the company’s novel bioadaptive implant, DynamX® Sirolimus-Eluting Coronary Bioadaptor System, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The breakthrough designation is for an indication to improve coronary luminal diameter, restore hemodynamic modulation, and reduce plaque progression in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The DynamX bioadaptor has a novel design and mechanism of action designed to return the diseased vessel to a more normal condition, through three distinct phases. After implantation, the locked phase establishes the maximum flow lumen and restores blood flow to treat symptoms of coronary artery disease (CAD). Unique to the bioadaptor, the second phase occurs after the bioadaptor is encapsulated with tissue and the absorbable polymer coating is resorbed. This enables the bioadaptor helical strands to unlock and separate, releasing and allowing the vessel to grow and adapt to maintain the established blood flow lumen. The third and most unique phase provides the vessel adaptive dynamic support by the separated helical strands. This restores the vessel viability and hemodynamic modulation by returning pulsatility, compliance, adaptive blood flow volume, and plaque stabilization and regression. FDA Breakthrough Device Designation accelerates the review process for novel technologies that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as CAD, which impacts 7.8% of the U.S. population.1 To date, interventional treatment of coronary artery disease with drug-eluting stents has been able to establish flow angiographically. However, up to 20% of patients experience a repeat adverse event related to the implant within five years of treatment.2 “For many years, it was thought that caging of the vessel with stents was the main driver for annual increasing non-plateauing event rates. However, the data with the ‘leave nothing behind’ approach with bioresorbable scaffold technologies, showed non-plateauing event rates continue to occur even after resorption of the scaffold, so we needed a more innovative approach to restore vessel viability,” said Motasim Sirhan, CEO of Elixir Medical.3 “We very much appreciate FDA’s breakthrough designation recognition of the bioadaptor technology,” continued Sirhan. “We look forward to working with FDA, Centers for Medicare & Medicaid Services, and respective physician societies to bring this technology to U.S. patients as soon as possible to elevate the standard of care for cardiovascular disease treatment.” “The Elixir team is honored to partner with the Invus Group, our financial partners. We are grateful for their unwavering commitment and support of our mission throughout the years,” continued Sirhan. Late-breaking two-year BIOADAPTOR RCT data presented at EuroPCR 20244 demonstrated a statistically significant benefit of DynamX bioadaptor over the standard of care, Resolute Onyx™ Drug-Eluting Stent (DES), where in patients treated for de novo lesions (per protocol patient population analysis), there was a 65% reduction in TLF rate (1.9% versus 5.5%; p=0.046) respectively. This reduction was driven by lower adverse events across all components of the composite endpoint for DynamX. In the critical left anterior descending (LAD) artery vessels the effect was even more pronounced with a 78% reduction (1.9% vs. 8.7%; p=0.028) in the TLF rate with DynamX bioadaptor versus DES. These data follow the 12-month results showing superiority over DES in imaging endpoints including lower % diameter stenosis, late lumen loss, and the new measures of vessel pulsatility, compliance and adaptive blood flow by restoring hemodynamic modulation and vessel viability.5 DynamX Coronary Bioadaptor System The DynamX bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, adaptive increase in blood flow volume, and providing plaque stabilization and regression. With a unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds demonstrated by remarkably low clinical event rates that showed a plateau between one-year and two-year clinical follow-up. The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the U.S. About Elixir Medical Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease that include DynamX BTK, LithiX Hertz Contact IVL and TRx site-specific antithrombotic therapy. Our technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at and on LinkedIn. 1 2 Madhavan MV, et al. Stent Related Adverse Events greater than 1 Year After PCI. JACC 2020. 3 . 4 Saito S, M.D. Presented at EuroPCR 2024. 5 Saito S, et al. BIOADAPTOR RCT 12-month clinical and imaging data. eClinicalMedicine Lancet 2023.