MedAlliance today said it received FDA breakthrough device designation for its Selution SLR sustained limus release drug-eluting balloon catheter.
Selution SLR is designed to treat atherosclerotic lesions in native coronary arteries. The breakthrough designation was awarded for its design of improving luminal diameter in patients with atherosclerotic lesions.
“MedAlliance is honored to have our sirolimus DEB selected for the FDA’s Breakthrough Device Program for a fourth time. This may provide US patients faster access to our novel 90 day sustained sirolimus release technology, with the potential to provide safer and more effective treatment,” CEO Jeffrey Jump said in a news release. “This designation, combined with the previous coronary ISR Breakthrough Designation, will give U.S. cardiologists exciting new tools to fight coronary disease.”
MedAlliance’s Selution SLR has unique MicroReservoirs that are made from biodegradable polymer that is intermixed with the anti-restenotic drug sirolimus. The MicroReservoirs provide controlled and sustained release of the drug.
Through the FDA breakthrough device program, the FDA will provide MedAlliance with priority review and interactive communication regarding the device’s development and clinical trial protocols, through to commercialization decisions.