MIAMI LAKES, Fla.–(BUSINESS WIRE)–#Cordis–Cordis, a global leader in interventional cardiovascular and endovascular technologies, today announced that the SELUTION SLR SUSTANE™ PTA Drug-Eluting Balloon (SUSTANE DEB) achieved the highest reported 12-month primary patency in the SELUTION4SFA US pivotal trial at 90.3%. The results were presented during a Late-Breaking Clinical Trial session at VIVA 2026 by Jay Mathews, MD, MS, Director, Cardiac Catheterization Laboratory, PERT & Structural Heart at Manatee Memorial Hospital/Bradenton Cardiology Center. Visit the Selution Portfolio clinical program page to learn more.
“The SELUTION4SFA results represent an important milestone in the evolution of PAD treatment confirming sirolimus drug-eluting balloon technology as an alternative treatment option,” said Jay Mathews, MD, MS. “Achieving primary patency over 90% at one year, the highest one-year primary patency rates reported in a U.S. drug-coated balloon pivotal trial, is impressive and demonstrates the potential for sirolimus drug-eluting balloon therapy to improve patient care.”
SELUTION4SFA was a prospective, multicenter, randomized trial enrolling 300 patients with symptomatic peripheral artery disease involving the superficial femoral and proximal popliteal arteries. The trial met its primary efficacy endpoint and demonstrated superiority to plain balloon angioplasty. The trial supports the SUSTANE DEB FDA submission as Cordis works toward potential U.S. approval of the first sirolimus drug-eluting balloon for the treatment of femoropopliteal disease.
Beginning with the first peripheral study in October 2016, the global Selution peripheral clinical program has expanded to 10 studies representing more than 1,900 patients. SELUTION4SFA is another positive study in this program, with randomized clinical data supporting the safe and effective use in treating peripheral arterial disease.
“Selution coronary and peripheral products are available in over 65 countries treating more than 250,000 patients worldwide,” said Matt Muscari, President of Americas, Cordis. “Since SELUTION SLR™ DEB was approved in the U.S. for coronary in-stent restenosis this September, physicians are adopting the technology rapidly, with strong interest in what it can offer patients. Now, with positive results from the SELUTION4SFA trial, this reinforces the potential for the Selution technology to address important needs beyond coronary disease. These results are an exciting step toward bringing SUSTANE DEB to physicians treating peripheral artery disease.”
SELUTION SLR SUSTANE™ PTA DEB is approved for investigational use only by the U.S. Food and Drug Administration for the treatment of disease in the superficial femoral or proximal popliteal arteries and is not commercially available. More details on the SELUTION4SFA are available on clinicaltrials.gov: NCT05132361.
About Cordis
From the first guidewire to the first drug-eluting stent, Cordis has been at the heart of cardiovascular innovation for nearly 70 years. Today, Cordis drives transformation through internal development, Cordis-X partnerships, and strategic acquisitions – powered by a global footprint and deep operational expertise. With a focus on better clinical outcomes, customer-centered service, and impactful education, Cordis will go beyond to relentlessly pursue its mission to transform cardiovascular care.
Contacts
Kelly May
Director, Corporate Communications
Cordis
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