12-Month Primary Patency Data Reported for Cordis Selution SLR Sustane PTA DEB

October 6, 2026—Cordis announced that its Selution SLR Sustane percutaneous transluminal angioplasty (PTA) sirolimus drug-eluting balloon (DEB) achieved a 12-month primary patency rate of 90.3% in the SELUTION4SFA United States pivotal trial.

S. Jay Mathews, MD, presented the results during a late-breaking clinical trial session at VIVA 2026, the Vascular Interventional Advances conference.

According to Cordis, SELUTION4SFA is a prospective, multicenter, randomized trial that enrolled 300 patients with symptomatic peripheral artery disease (PAD) involving the superficial femoral and proximal popliteal arteries. The trial met its primary efficacy endpoint and demonstrated superiority to plain balloon angioplasty.

The company stated that the trial supports its submission to the FDA for approval of the Sustane DEB for the treatment of femoropopliteal disease. More information is available online at Cordis’s Selution Portfolio clinical program page.

“The SELUTION4SFA results represent an important milestone in the evolution of PAD treatment confirming sirolimus DEB technology as an alternative treatment option,” commented Dr. Mathews in the Cordis press release. “Achieving primary patency over 90% at 1 year, the highest 1-year primary patency rates reported in a United States drug-coated balloon pivotal trial, is impressive and demonstrates the potential for sirolimus DEB therapy to improve patient care.”

Selution SLR Sustane PTA DEB is approved for investigational use only by the FDA for the treatment of disease in the superficial femoral or proximal popliteal arteries and is not commercially available, advised Cordis.