Cordis has won FDA approval for Selution SLR DEB, a sirolimus drug-eluting balloon for coronary in-stent restenosis, or ISR. The company described the product as the first and only sirolimus drug-eluting balloon cleared in the U.S. for that use, and the agency reviewed it under the breakthrough device designation.
The commercial significance is less about novelty alone than about positioning. In ISR, physicians are treating failure inside a previously placed stent, so a device that delivers drug therapy while helping minimize the need for another stent addresses a practical treatment tradeoff in a procedure setting that is already large. Cordis said about 1 million percutaneous coronary interventions are performed in the U.S. each year, with about 10% addressing ISR.
The data
Cordis said Selution SLR DEB delivers sustained sirolimus therapy without leaving a permanent implant in the patient. Sirolimus is an immunosuppressive agent typically used to prevent rejection of a transplanted organ.
The approval was supported by a study of more than 400 patients across the U.S., Canada, Brazil and Europe. Cordis said the trial evaluated the balloon against standard care, which included 80% drug-eluded stents.
The road here
The FDA decision gives Cordis a U.S. entry in a category it had been building toward since acquiring Swiss manufacturer MedAlliance in 2022. That deal was valued at $1.1 billion over a seven-year period and included the Selution device.
Cordis also said it has completed enrollment in a 960-patient study comparing the Selution SLR DEN device with drug-eluting stents for de novo lesions in small coronary vessels, work the company plans to use as part of a future FDA pre-market approval application. That makes the current approval look like the first U.S. regulatory step in a broader drug-eluting balloon buildout rather than a one-off device launch.
