The US Food and Drug Administration has approved Cordis' SELUTION SLR drug-eluting balloon for treating coronary in-stent restenosis. The device is the first sirolimus drug-eluting balloon approved in the United States. The approval follows results from the SELUTION4ISR trial, which enrolled over 400 patients across 48 sites in the US, Canada, Brazil, and Europe. At 12 months, target lesion failure rates were 15.2% for SELUTION SLR and 13.5% for standard of care treatments. Nearly 1 million percutaneous coronary interventions are performed annually in the US, with approximately 10% addressing in-stent restenosis. Cordis has completed enrollment in a 960-patient trial evaluating the balloon versus drug-eluting stents for treating small coronary vessel lesions.

Cordis has launched its SELUTION SLR™ PTA Drug-Eluting Balloon in Japan, the first sirolimus-eluting balloon approved in the country for treating peripheral artery disease. The device delivers sirolimus in a controlled manner to reduce restenosis and restore vessel function. The SELUTION SFA Japan clinical trial showed durable outcomes in complex patients, with 81.5% primary patency and 93.8% of patients remaining free from reintervention through three years. Early clinical experience has shown strong post-procedural blood flow without downstream effects below the knee. The launch provides Japanese physicians with an additional treatment option for managing peripheral vascular disease patients. Cordis, a global interventional vascular technology company, has been developing cardiovascular innovations for nearly 70 years.