Cordis, a global leader in the development and manufacturing of interventional cardiovascular and endovascular technology, 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.
"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 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.
For more information about Cordis, please visit www.cordis.com
