The US Food and Drug Administration (FDA) has approved Cordis’ SELUTION SLR [sustained limus release] drug-eluting balloon (DEB) to treat coronary in-stent restenosis (ISR).
This move brings a new device option to address ISR, which remains a key challenge in interventional cardiology.
Physicians in the US now have immediate access to the SELUTION SLR DEB, which delivers sustained sirolimus therapy to coronary vessels without leaving a permanent implant.
The device has obtained breakthrough designation and is supported by results from the SELUTION4ISR trial.
This prospective study involved more than 400 patients at 48 clinical sites in Brazil, Canada, Europe, and the US. It compared the SELUTION SLR DEB to standard of care, which included 80% drug-eluting stents, in coronary ISR patients.
At 12 months, target lesion failure occurred in 15.2% of patients receiving the SELUTION SLR device and 13.5% of those treated with standard therapies, with the primary endpoint of non-inferiority met in the target population.
Cordis stated that clinical evidence for SELUTION SLR DEB includes data from more than 5,000 patients worldwide.
Beyond coronary ISR, Cordis has also finished enrolling participants in the SELUTION4DeNovo IDE trial.
This US study involves 960 patients and aims to compare SELUTION SLR DEB with drug-eluting stents for the treatment of de novo lesions in small coronary vessels, with plans to support a future FDA premarket approval application.
Cordis Americas president Matt Muscari said: “FDA approval of the SELUTION SLR DEB represents a transformative milestone for Cordis and a defining advancement in our mission to transform cardiovascular care.
“As the first and only sirolimus drug-eluting balloon approved in the US, 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.”
