FDA Approves First Sirolimus Drug-Eluting Balloon for Coronary In-Stent Restenosis

Coronary in-stent restenosis (ISR) accounts for about 10% of the nearly one million percutaneous coronary interventions performed annually in the United States. Treating recurrent narrowing without another permanent implant remains a priority. A newly approved device expands these options as the first sirolimus drug-eluting balloon in the U.S. for coronary ISR.

SELUTION SLR (Sustained Limus Release) Drug-Eluting Balloon (DEB) from Cordis (Miami Lakes, FL, USA) received U.S. Food and Drug Administration (FDA) approval for treating coronary ISR. The approval makes it the first and only sirolimus DEB in the United States, giving physicians access to a sirolimus-based treatment that leaves no additional permanent implant. The device also holds FDA Breakthrough Device designation.

The DEB is engineered to deliver sirolimus directly into the vessel wall for up to 90 days, helping prevent recurrent narrowing without leaving a permanent implant. This sustained-release approach is intended specifically for treating coronary ISR.

FDA approval was supported by SELUTION4ISR, a randomized, single-blind, controlled noninferiority trial comparing SELUTION SLR with standard care, which involved drug-eluting stents in 80% of cases. The study enrolled more than 400 patients across 48 sites in the United States, Canada, Brazil, and Europe. At 12 months, the trial met its primary endpoint, with target lesion failure occurring in 15.2% of patients assigned to SELUTION SLR versus 13.5% assigned to standard care.

Nearly one million percutaneous coronary interventions are performed annually in the United States, with approximately 10% addressing ISR. Beyond this indication, enrollment has been completed in the 960-patient SELUTION4DeNovo randomized study, which compares the DEB with drug-eluting stents for de novo small-vessel lesions to support a future premarket approval application. SELUTION SLR is commercially available in more than 65 countries and has been used in over 250,000 patients worldwide.

“FDA approval of the SELUTION SLR DEB represents a transformative milestone for Cordis and a defining advancement in our mission to transform cardiovascular care. As the first and only sirolimus drug-eluting balloon approved in the United States, SELUTION SLR DEB introduces a groundbreaking therapy for the treatment of coronary ISR. This innovative device will enable physicians to address one of the most complex coronary clinical challenges. The introduction of SELUTION SLR DEB reinforces Cordis’ commitment to delivering differentiated technologies that expand treatment possibilities and improve outcomes for patients,” said Matt Muscari, president of Americas, Cordis.