Cordis Selution SLR DEB Evaluated at 24 Months in SELUTION SFA Japan Trial

June 18, 2024—Cordis announced that 24-month results from the SELUTION SFA Japan trial demonstrate sustained benefits with the company’s Selution SLR—sustained limus release—drug-eluting balloon (DEB).

The prospective, multicenter, single-arm trial is designed to assess the safety and efficacy of Selution SLR for the endovascular therapy of de novo and nonstented restenotic lesions in the superficial femoral artery (SFA) and popliteal artery (PA).

The Selution SLR technology uses microreservoirs made from biodegradable polymer intermixed with sirolimus that provide the controlled sustained release of the drug, noted Cordis.

The 24-month findings were presented at JET2024, the Japan Endovascular Treatment conference held June 14-16 in Fukuoka, Japan.

According to Cordis, the long-term follow-up of the 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% patients with diabetes. Additionally, patients in the study had a mean lesion length of 127 mm, 17.2% total occlusions, and 47.8% involvement of the PA.

As summarized in the Cordis press release, the Selution SLR DEB delivered primary patency of 83% and clinically driven target lesion revascularization of 95.4% at 24 months. The trial results demonstrated consistency of the Selution SLR DEB in being a safe and effective treatment option for femoropopliteal disease.

“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,” commented Osamu Iida, MD, in the Cordis press release.

Dr. Iida, from Osaka Police Hospital Cardiovascular Division in Osaka, Japan, continued, “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.”

According to Cordis, the SELUTION SFA Japan trial is one of the first of several large trials in the Selution SLR DEB clinical trial portfolio. Four major randomized controlled trials and one real-world registry data are currently underway in the treatment of coronary, SFA, and below-the-knee (BTK) arteries.

The Selution SLR DEB coronary, SFA, and BTK platforms are commercially available in Europe, the Middle East, several markets across Asia and Latin America, and most other countries where the European CE Mark is recognized.

In the United States, the Selution SLR DEB is investigational and not approved for sale or distribution, advised Cordis.