FDA Approves Cordis SELUTION SLR Sirolimus Drug-Eluting Balloon for Coronary In-Stent Restenosis
核心洞察
The FDA has approved Cordis' SELUTION SLR (搜索) drug-eluting balloon for coronary in-stent restenosis (搜索), the first and only sirolimus-coated balloon cleared in the United States.
Approval rests on the SELUTION4ISR trial, which enrolled more than 400 patients across 48 sites and met its 12-month primary endpoint of non-inferiority versus standard of care.
In all randomized patients, target lesion failure occurred in 15.2% of SELUTION SLR (搜索) recipients versus 13.5% with standard of care, which included 80% drug-eluting stents.
The U.S. Food and Drug Administration has approved the SELUTION SLR (搜索) (Sustained Limus Release) Drug-Eluting Balloon for the treatment of coronary in-stent restenosis (搜索), Cordis announced. The device becomes the first and only sirolimus drug-eluting balloon approved in the United States, and Cordis said physicians now have immediate access to it.
The balloon is designed to deliver sustained sirolimus therapy without leaving a permanent implant behind. According to Cordis, SELUTION SLR (搜索) provides Sustained Limus Release for up to 90 days. The device is commercially available in more than 65 countries and has been used in the treatment of over 250,000 patients worldwide.
"FDA approval of the SELUTION SLR (搜索) DEB represents a transformative milestone for Cordis and a defining advancement in our mission to transform cardiovascular care," said Matt Muscari, President of Americas at Cordis. "As the first and only sirolimus drug-eluting balloon approved in the United States, SELUTION SLR DEB introduces a groundbreaking therapy for the treatment of coronary ISR."
SELUTION4ISR Trial Results
The FDA designated SELUTION SLR (搜索) as a Breakthrough Device. The approval is supported by results from SELUTION4ISR, a prospective, multicenter, randomized, single-blind, controlled non-inferiority study that evaluated the balloon against standard of care, which included 80% drug-eluting stents, in patients with coronary in-stent restenosis (搜索).
The trial enrolled more than 400 patients across 48 sites in the United States, Canada, Brazil, and Europe. At 12 months the study met its primary endpoint of non-inferiority in the target population. On the per-protocol primary endpoint analysis, target lesion failure was 16.2% for SELUTION SLR (搜索) and 14.5% for standard of care. In all randomized patients, target lesion failure rates were 15.2% for SELUTION SLR and 13.5% for standard of care.
Cordis said these results strengthen the clinical evidence supporting SELUTION SLR (搜索), which includes data from more than 5,000 patients worldwide.
"We recognize the toll coronary artery disease and repeat procedures can take on patients and their families," said George Adams, MD, Chief Medical Officer at Cordis. "The availability of SELUTION SLR (搜索) 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."
Disease Burden and Treatment Setting
In the United States, nearly 1 million percutaneous coronary interventions are performed annually, with approximately 10% addressing in-stent restenosis, according to Cordis. With this approval, the company is entering the coronary drug-coated balloon market.
Cordis describes itself as a pioneer in sirolimus-based innovation, having introduced the first sirolimus drug-eluting stent in the United States in 2003.
De Novo Lesion Program Advances
Beyond in-stent restenosis, Cordis announced completed enrollment in the SELUTION4DeNovo IDE trial, a 960-patient randomized study evaluating SELUTION SLR (搜索) against drug-eluting stents for the treatment of de novo lesions in small coronary vessels. The trial is intended to support a future FDA premarket approval application.