FDA approves Boston Scientific’s Innova stent system

by Lauren Dubinsky, Senior Reporter | August 20, 2015
Cardiology Medical Devices Population Health
Innova Vascular Self-Expanding
Stent System
Boston Scientific Corporation announced yesterday that its Innova Vascular Self-Expanding Stent System received FDA approval. The new system could represent a major breakthrough in the treatment of peripheral artery disease (PAD).

Before a patient develops PAD, their superficial femoral artery (SFA) or proximal popliteal artery (PPA) narrows and becomes blocked. That then causes a build-up of plaque in one or more of the arteries, usually in the legs.

About 8 million people in the U.S. have PAD, according to the Centers for Disease Control and Prevention. PAD of the lower extremities can cause painful ulcers, infections or amputation of the toes or feet.

The SFA and PPA are challenging environments for stents, but the Innova stent platform’s flexibility, radial strength and fracture resistance is specifically designed for that anatomy.

The system is composed of a nitinol self-expanding bare metal stent with an advanced delivery system. It’s available in a range of sizes including diameters from 5 mm to 8 mm and lengths of 20 mm to 200 mm.

The system utilizes something called "hybrid cell architecture", which consists of open cells along the stent body and closed cells at each end. The stent was designed this way to ensure accurate and uniform deployment into the artery.

"The Innova delivery system allowed me to place the stent smoothly and accurately," Dr. Jaafer Golzar, M.D., interventional cardiologist at Advocate Christ Medical Center and the first to use the Innova Stent System in a clinical procedure following FDA approval, said in a statement.

The system also serves as the foundation for the new Eluvia Drug-Eluting Vascular Stent that is designed specifically for the SFA. However, the Eluvia stent is pending CE Mark and is not available for sale in the U.S.

"The Innova and the Eluvia Stent Systems together demonstrate our commitment to improving health outcomes in the treatment of a disease affecting more than 200 million people worldwide,” Jeff Mirviss, president of peripheral interventions at Boston Scientific, said in a statement.

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