Cordis Announces Positive 24-Month Results from the SELUTION Superficial Femoral Artery (SFA) Japan Study
By Azmed Devices Editorial Team
Cordis has announced positive 24-month results for its SELUTION SLR Drug-Eluting Balloon from the SELUTION SFA Japan trial, demonstrating sustained safety and efficacy in treating femoropopliteal disease.
According to Cordis, the SELUTION SFA Japan trial has yielded positive 24-month results regarding the safety and efficacy of the SELUTION SLR Drug-Eluting Balloon for treating de novo and non-stented restenotic lesions in the superficial femoral artery and popliteal artery. The prospective, multi-center, single-arm trial demonstrated primary patency of 83.0% and 94.5% freedom from clinically driven target lesion revascularization at the 24-month mark in a complex patient population.
According to Cordis, the long-term follow-up confirms efficient sirolimus drug transfer and retention. The study population included 60.3% diabetic patients, a mean lesion length of 127 mm, 17.2% total occlusions, and 47.8% involvement of the popliteal artery. These findings were presented at the Japan Endovascular Treatment Conference 2024, highlighting the device as a consistent treatment option for patients with femoropopliteal disease.
According to Cordis, these results validate previous clinical experience and bolster confidence in the company's broader SELUTION SLR Drug-Eluting Balloon clinical portfolio. The company is currently managing four major randomized controlled trials and one real-world registry dataset covering coronary, superficial femoral artery, and below-the-knee arteries, as part of its ongoing commitment to generating clinical evidence that advances the standard of cardiovascular care.
Source
This article summarizes an official Cordis announcement. Read the original at https://cordis.com/emea/news/cordis-announces-positive-24-month-results-from-superficial-femoral-artery-study-from-the-selution-sfa-japan-trial. Product availability in Azerbaijan is subject to local registration; contact Azmed Devices for current status.
