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FDA approves Boston Scientific’s Innova Vascular Self-Expanding Stent system

Medical equipment manufacturer Boston Scientific has obtained approval from the US Food and Drug Administration (FDA) for its Innova Vascular Self-Expanding Stent system.


Innova system is an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery (SFA) or proximal popliteal artery (PPA), which will cause a circulatory disorder called peripheral artery disease (PAD).

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 Innova stent platform includes a Nitinol self-expanding bare metal stent with an advanced delivery system. It is available in different sizes ranging diameters from 5mm to 8mm and lengths of 20mm to 200mm.

The stents platform is said to serve as the foundation for the new Eluvia Drug-Eluting Vascular Stent, designed specifically for the SFA.

Innova system also features a hybrid cell architecture with open-cells along the stent body and closed cells at each end for uniform and accurate deployment.

Image: Boston Scientific’s Innova Vascular Self-Expanding Stent system. Photo: courtesy of Boston Scientific Corporation.