FDA Approves Breakthrough's Selution SLR Drug-Eluting Balloon for Coronary ISR

The U.S. Food and Drug Administration has approved the Selution SLR (Sustained Limus Release) Drug-Eluting Balloon (DEB) manufactured by Breakthrough. This device is intended for the treatment of coronary in-stent restenosis (ISR) and delivers sustained sirolimus therapy without creating a permanent implant. The approval follows the device being designated as a Breakthrough Device and is supported by results from the SELUTION4ISR trial.

The approval establishes the Selution SLR DEB as the first sirolimus drug-eluting balloon approved in the United States for this indication. This introduction provides physicians with immediate access to a groundbreaking therapy for complex coronary clinical challenges, significantly advancing the field of cardiovascular care.