PAD: FDA approves Boston Scientific’s Innova stent

Boston Scientific (NYSE:BSX) yesterday said the FDA approved its Innova stent for treating peripheral artery disease, 4 years after the medical device company recalled some lots of the product.

The self-expanding stent is designed to treat obstructions of the superficial femoral artery or proximal popliteal artery. Boston Scientific recalled some of the Innova devices overseas in 2011, after receiving reports that the stent, used to treat lesions in the femoral artery and the adjacent proximal popliteal artery, failed to deploy completely or only partially deployed.

Yesterday Marlborough, Mass.-based Boston Scientific said the Innova platform is the foundation for its newer Eluvia drug-eluting PAD stent.

This stent platform serves as the foundation for the new Eluvia drug-eluting vascular stent, designed specifically for the SFA.

“This is an important therapy for a disease that can have life-changing consequences, including limb amputation,” peripheral interventions president Jeff Mirviss said in prepared remarks. “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.”

“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,” added Dr. Richard Powell of the Dartmouth Hitchcock Medical Center in Lebanon, N.H., the principal investigator in the SuperNOVA trial for Innova. “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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