MedAlliance’s Selution SLR Receives Fourth FDA Breakthrough Device Designation

March 3, 2021—MedAlliance announced it has received FDA Breakthrough Device designation for the Selution SLR sirolimus drug-eluting balloon catheter to improve luminal diameter in patients with atherosclerotic lesions in native coronary arteries.

The company noted that the device was previously granted the designation for coronary in-stent restenosis, peripheral below-the-knee, and arteriovenous fistula indications.

Selution SLR’s technology includes microreservoirs made from biodegradable polymer mixed with the antirestenotic drug sirolimus, as well as MedAlliance’s cell-adherent technology (CAT). The microreservoirs provide controlled and sustained release of the drug. CAT enables the microreservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon, stated MedAlliance.

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.