FDA Approves Boston Scientific's Innova Bare Stent for Peripheral Artery Disease

Boston Scientific Corporation, a global medical technology company, has received Food and Drug Administration (FDA) approval for the Innova Vascular Self-Expanding Stent System. "It is gratifying to be able to offer this minimally invasive therapy to improve the quality of life in those patients who suffer from PAD.

The SFA and proximal popliteal arteries present a challenging environment for stents.

The flexibility, radial strength and fracture resistance of the Innova Stent are designed specifically for this anatomy," said Richard Powell, M.D., section chief, Department of Vascular Surgery, The stent platform consists of a Nitinol self-expanding bare metal stent with an advanced delivery system.

It is also 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 of uniform and accurate deployment. This stent platform serves as the foundation for the new Eluvia Drug-Eluting Vascular Stent, designed specifically for the SFA.

The Innova Stent System was designed with an intuitive triaxial delivery system for precise, predictable stent placement and uniform deployment," said the company in a press release.

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Dr. Jaafer Golzar, a clinical assistant professor, University of Illinois at Chicago and director of Limb Salvage & Endovascular Intervention, Advocate Trinity Hospital, Chicago, said, "The Innova delivery system allowed me to place the stent smoothly and accurately. The first step to achieving an optimal outcome is accurate placement, and then stent properties like radial strength and flexibility come into play."

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Source-Medindia