MedAlliance Receives FDA Breakthrough Device Designation Status for Sirolimus Drug-Eluting Balloon to Treat Below-the-Knee Disease
25 September 2019 – MedAlliance, the first drug-eluting balloon company in the world to receive US Food and Drug Administration (FDA) Breakthrough Device Designation Status for the treatment of coronary ISR, has been awarded similar status for SELUTION SLR™, its sustained limus release drug-eluting balloon (DEB) catheter, for the treatment of Below-the-Knee Disease.
SELUTION’s technology involves unique micro-reservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These micro-reservoirs provide controlled and sustained release of sirolimus. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the micro-reservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
“MedAlliance is honored to have our sirolimus DEB selected for the FDA’s Breakthrough Device Program a second time. This should give US patients faster access to a new technology with the potential to provide safer and more effective treatment,” said Jeffrey B. Jump, Chairman and CEO of MedAlliance.
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.
Clinical follow-up data on the company’s SFA (superficial femoral artery) sirolimus DEB will be presented at TCT later this week. TCT will also see the debut of the sirolimus DEB coronary FIM data from the Asian study in which 84% of the patients received the sirolimus balloon in coronary de novo lesions.