MedAlliance ‘Breakthrough’ for Drug-Eluting Catheter

FDA has granted MedAlliance a breakthrough designation for its Selution SLR, a sustained drug-eluting (sirolimus) catheter for treating atherosclerotic lesions in native coronary arteries. FDA awarded the designation for improving luminal diameter in patients with atherosclerotic lesions in native coronaries, the company says.

MedAlliance says the technology involves “unique MicroReservoirs” made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. The 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,” the company says. “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.”