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August 19, 2015

FDA approves Boston Scientific’s Innova vascular self-expanding stent system

The US Food and Drug Administration (FDA) has granted approval for Boston Scientific's new therapy that is designed to treat peripheral artery disease (PAD).

Innova system

The US Food and Drug Administration (FDA) has granted approval for Boston Scientific’s new therapy that is designed to treat peripheral artery disease (PAD).

The Innova vascular self-expanding stent system is an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery (SFA) or proximal popliteal artery (PPA), which eventually leads to PAD.

Driven by a build-up of plaque in one or more of the arteries, most often in the legs, PAD is a circulatory disorder.

In lower extremities, it can lead to painful ulcers, infections or amputation of the toes or feet.

"This is an important therapy for a disease that can have life-changing consequences, including limb amputation."

Dartmouth-Hitchcock Medical Center, Lebanon, Department of Vascular Surgery section chief Richard Powell said: "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."

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Comprising a Nitinol self-expanding bare metal stent with an advanced delivery system, the Innova stent platform is available in a range of sizes, including diameters from 5mm – 8mm and lengths of 20mm – 200mm.

The system features hybrid cell architecture with open-cells along the stent body and closed cells at each end for uniform and accurate deployment, and serves as the foundation for the new Eluvia drug-eluting vascular stent, which is designed specifically for SFA.

Boston Scientific Peripheral Interventions president Jeff Mirviss said: "This is an important therapy for a disease that can have life-changing consequences, including limb amputation.

"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."

The company started a full commercial launch of the Innova stent system in the US.


Image: The Innova vascular self-expanding stent system is designed to treat peripheral artery disease. Photo: courtesy of Boston Scientific Corporation.

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