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 ™ DEBSELUTION 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 CordisCordis 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 www.cordis.com and follow Cordis on LinkedIn.Media Contact:Chris BinghamVice President, Global Market & Strategy[email protected]SOURCE Cordis
