MedAlliance has been awarded breakthrough status for SELUTION SLR, its sustained limus discharge DEB catheter, in the treatment of atherosclerotic lesions in native coronary arteries.
FREMONT, CA: MedAlliance, the first drug-eluting balloon (DEB) corporation in the world to be granted Breakthrough Device Designation Status by the US Food and Drug Administration (FDA) for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR, its sustained limus discharge DEB catheter, in the treatment of atherosclerotic lesions in native coronary arteries. Following coronary in-stent restenosis, peripheral below-the-knee, and AV-Fistula indications, this is MedAlliance's fourth breakthrough designation award for its sirolimus DEB.
As per the FDA, the SELUTION SLR 014 DEB Breakthrough Designation is for enhancing luminal diameter in patients with atherosclerotic lesions in native coronaries.
"MedAlliance is honoured 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," said Jeffrey B. Jump, Chairman, and CEO of MedAlliance. "This Designation, combined with the previous coronary ISR Breakthrough Designation, will give US cardiologists exciting new tools to fight coronary disease."
The FDA Breakthrough Device Program aims to help patients get timely access to breakthrough devices that can offer efficient treatment or therapy for life-threatening or irreversibly crippling diseases and conditions. Under the terms of the program, the FDA will give MedAlliance priority analysis and interactive communication about device production and clinical trial protocols, all the way to commercialization decisions.
The Breakthrough Devices Program's motive is to offer patients and healthcare providers faster access to the medical devices by accelerating their development, evaluation, and review while maintaining the statutory requirements for premarket approval, 510(k) clearance, and de novo marketing authorization, following the Agency's mission to protect and promote public health.
SELUTION SLR's technology uses special MicroReservoirs made of a biodegradable polymer combined with the anti-resteotic drug sirolimus. The MicroReservoirs provides a regulated and sustained release of the drug. Extended sirolimus release from stents has proven to be extremely effective in coronary and peripheral arteries. The MicroReservoirs can be coated onto balloons and attach to the vessel lumen when delivered through an angioplasty balloon with the help of MedAlliance's patented CAT (Cell Adherent Technology).