• The FDA approved a drug-eluting balloon for the treatment of coronary in-stent restenosis.
• The device is the first sirolimus-eluting balloon to be approved in the U.S. for this indication.

The FDA approved a next-generation sirolimus-eluting balloon for the treatment of coronary in-stent restenosis, Cordis announced.

The drug-eluting balloon (Selution SLR, Cordis) is the first sirolimus-eluting balloon to be approved in the U.S. and is designed to provide sustained limus release for up to 90 days without requiring a permanent implant, according to a company press release. As Healio previously reported, in 2024, the FDA approved a paclitaxel-coated balloon (Agent, Boston Scientific) to treat coronary in-stent restenosis.

Approval of the sirolimus-eluting balloon was based on the results of the prospective, multicenter, randomized, noninferiority SELUTION4ISR trial, for which researchers compared with drug-eluting balloon with standard of care in 418 patients with coronary in-stent restenosis.

As Healio previously reported, the drug-eluting balloon met its primary endpoint of noninferiority for 1-year target vessel failure in both the per-protocol and intention to treat analyses, with no differences in safety and secondary endpoints, including all-cause mortality.

“We recognize the toll coronary artery disease and repeat procedures can take on patients and their families,” George Adams, MD, chief medical officer for Cordis, said in the release. “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.”