MedAlliance Receives FDA Breakthrough Device Designation for Selution SLR Sirolimus-Eluting Balloon to Treat BTK Disease
September 25, 2019—MedAlliance announced that the FDA awarded Breakthrough Device designation status for the company's Selution SLR, a sustained limus-release drug-eluting balloon (DEB) catheter for the treatment of below-the-knee disease.
Selution’s technology features microreservoirs made from biodegradable polymer intermixed with the antirestenotic drug sirolimus. The microreservoirs provide controlled and sustained release of sirolimus. MedAlliance’s cell adherent technology enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
The goal of the FDA's Breakthrough Devices program is to provide patients and health care 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 FDA's mission to protect and promote public health.
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.