FDA approves Innova vascular self-expanding stent system for PAD- Boston Scientific

Boston Scientific has received FDA approval for the Innova Vascular Self-Expanding Stent System, an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery (SFA) or proximal popliteal artery (PPA). This can cause peripheral artery disease (PAD), a circulatory disorder that results from a build-up of plaque in one or more of the arteries, most often in the legs. The SuperNOVA trial evaluated the safety and effectiveness of the Innova Stent System.

Comment: The Innova stent platform consists of a Nitinol self-expanding bare metal stent with an advanced delivery system, and is available in a range of sizes, including diameters from 5 mm to 8 mm and lengths of 20 mm to 200 mm. It features a hybrid cell architecture with open-cells along the stent body and closed cells at each end for uniform and accurate deployment. This stent platform serves as the foundation for the new Eluvia Drug-Eluting Vascular Stent, designed specifically for the SFA.