MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a sirolimus DEB, has now been awarded breakthrough status for SELUTION SLR™, its sustained limus release DEB catheter, in the treatment of atherosclerotic lesions in native coronary arteries. This is the fourth breakthrough designation awarded to MedAlliance for its sirolimus DEB, following coronary in-stent restenosis, peripheral below-the-knee and AV-Fistula indications.
According to the FDA, the SELUTION SLR 014 DEB Breakthrough Designation is for improving 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 is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide MedAlliance with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and de novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.
SELUTION SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug. Extended release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.