FDA Clears Sirolimus-Coated Balloon for Stent Reblockage
The U.S. Food and Drug Administration has approved a new drug-coated balloon from Cordis for treating narrowed coronary arteries previously stented. The device, which releases sirolimus for up to 90 days, met noninferiority criteria against drug-eluting stents in a 418-patient trial, with target lesion failure rates of 15.2% versus 13.5% at one year. It is the first sirolimus-based balloon of its kind cleared in the United States.
The Selution SLR balloon delivers sirolimus over 90 days while avoiding an additional metal stent layer during PCI. Its approval rests on the SELUTION4ISR trial, which randomized 418 patients and showed noninferiority against drug-eluting stents, with target lesion failure at 15.2% versus 13.5% at one year. Exclusions included STEMI patients and those with heavily layered prior stenting.
Cordis's device follows Boston Scientific's paclitaxel-coated Agent DCB, cleared two years earlier, though that pivotal study used plain balloon angioplasty as its comparator. Head-to-head data between the two balloons remain unavailable, and long-term outcomes for drug-coated balloons in ISR are still under investigation. The Selution balloon also met noninferiority for de novo coronary lesions in a separate trial.
This approval could expand treatment options for patients with recurrent coronary narrowing after stenting, potentially reducing repeat procedures and the need for additional metal implants. Interventional cardiologists may gain a sirolimus-based alternative to paclitaxel-coated balloons, though comparative effectiveness between the two remains unknown. Patients with complex prior stenting may benefit most, but long-term durability data are still emerging, so clinical adoption may proceed cautiously.