FDA approves Boston Scientific stent system
Boston Scientific of Marlborough has received Food and Drug Administration approval for its Innova stent system for treatment of patients with peripheral artery disease.
The Innova Vascular Self-Expanding Stent System is designed to treat narrowing or blockages in the superficial femoral artery or proximal popliteal artery, conditions that can lead to peripheral artery disease, Boston Scientific said in a statement Wednesday. The circulatory disorder, affecting more than 200 million people worldwide, results from a buildup of plaque in one or more of the arteries, most often in the legs, 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,” said Jeff Mirviss, president of the Peripheral Interventions division at Boston Scientific.
Boston Scientific has begun a full commercial launch of the Innova Stent System in the U.S., the statement said.
The Innova stent platform consists of a Nitinol self-expanding bare metal stent. It serves as the foundation for the new Eluvia Drug-Eluting Vascular Stent, designed specifically for the superficial femoral artery, the company said.
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