Boston Scientific: FDA Okays Innova Vascular Self-Expanding Stent System

(RTTNews) - Medical devices maker Boston Scientific Corp (BSX) on Wednesday said the U.S. Food and Drug Administration has approved the Innova Vascular Self-Expanding Stent System, an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery. The company said it has commenced a full commercial launch of the Innova Stent System in the U.S.

The narrowing or blockages in the superficial femoral artery or proximal popliteal artery can cause peripheral artery disease, a circulatory disorder that results from a build-up of plaque in one or more of the arteries, most often in the legs. PAD of the lower extremities can lead to painful ulcers, infections, or amputation of the toes or feet

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.