Cordis has announced that the US Food and Drug Administration (FDA) has approved the Selution SLR (sustained limus release) drug-eluting balloon (DEB) for the treatment of coronary in-stent restenosis (ISR).
Physicians now have immediate access to the Selution SLR DEB, a next-generation drug-coated balloon (DCB) designed to deliver sustained sirolimus therapy without leaving a permanent implant behind.
“FDA approval of the Selution SLR DEB represents a transformative milestone for Cordis and a defining advancement in our mission to transform cardiovascular care,” said Matt Muscari, president of Americas, Cordis. “As the first and only sirolimus drug-eluting balloon approved in the USA, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary ISR. This innovative device will enable physicians to address one of the most complex coronary clinical challenges. The introduction of Selution SLR DEB reinforces Cordis’ commitment to delivering differentiated technologies that expand treatment possibilities and improve outcomes for patients.”
Designated as a breakthrough device, Selution SLR DEB is supported by results from the SELUTION4ISR trial, a prospective, multicentre, randomised, single-blind, controlled non-inferiority study that evaluated the device against standard of care (SOC), including 80% drug-eluting stents (DES), in patients with coronary ISR. The trial enrolled more than 400 patients across 48 sites in the USA, Canada, Brazil, and Europe. At 12 months the study met its primary endpoint of non-inferiority in the target population. In all randomised patients, target lesion failure (TLF) rates were 15.2% for Selution SLR and 13.5% for SOC.
Beyond ISR, Cordis has announced the completed enrolment in the SELUTION4DeNovo IDE trial, a 960-patient randomised study evaluating Selution SLR DEB versus drug-eluting stents for the treatment of de novo lesions in small coronary vessels in support of a future FDA premarket approval application.
“We recognise the toll coronary artery disease and repeat procedures can take on patients and their families,” said George Adams, chief medical officer, Cordis. “The availability of Selution SLR DEB in the USA is meaningful for interventional cardiologists because it provides an effective and highly deliverable sirolimus-based treatment option while helping minimise the need for another stent. We are proud to help expand treatment choices in ways that can make a real difference in patient care.”
