Cordis Wins FDA Nod for Selution SLR Sirolimus-Eluting Balloon

Cordis has earned U.S. Food and Drug Administration (FDA) approval for its Selution SLR (sustained [siro]limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis (ISR).

The company entered the U.S. coronary drug-coated balloon market with this approval. Selution SLR debuted in Japan in July.

The next-gen DEB provides sirolimus therapy for up to 90 days without leaving behind a permanent implant. Designated as an FDA breakthrough device, it’s backed by the SELUTION4ISR trial, a prospective, multicenter, randomized, single-blind study comparing the device with standard of care, including 80% drug-eluting stents, in patients with coronary ISR.

The trial enrolled over 400 patients at 48 sites across the U.S., Canada, Brazil, and Europe and met its 12-month primary endpoint of non-inferiority. Among all randomized patients, target lesion failure occurred in 15.2% of the Selution SLR group versus 13.5% for standard of care. The findings add to clinical evidence from more than 5,000 patients worldwide.

The company also completed enrollment in the 960-patient SELUTION4DeNovo IDE trial, which compares newly approved DEB with drug-eluting stents for de novo lesions in small coronary vessels to support future FDA premarket approval application.

Comments from Cordis execs

George Adams, MD: “We recognize the toll coronary artery disease and repeat procedures can take on patients and their families. The availability of SELUTION SLR DEB in the United States is meaningful for interventional cardiologists because it provides an effective and highly deliverable sirolimus-based treatment option while helping minimize the need for another stent. We are proud to help expand treatment choices in ways that can make a real difference in patient care.”

Matt Muscari, president of Americas: “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.”