Medical device maker Boston Scientific Corp. said its stent to prevent the blocking of arteries in the legs was approved in the United States, four years after the device was recalled outside the country due to partial or no deployments.
The device consists of a self-expanding metal stent with an advanced delivery system that helps in accurate deployment, the company said Wednesday.
The Innova Vascular Self-Expanding Stent is implanted into the arteries in the legs to prevent peripheral artery disease, which can lead to painful ulcers and infections, or even amputation of the toes or feet.
The company recalled over 500 devices in 2011 as partial deployments could result in vessel wall injury, increased procedure time or an emergency surgery to remove it.
The stent was approved in Europe in 2011.
Boston Scientific also develops another medical device called the Eluvia stent that uses Innova’s technology and is specifically designed for the femoral artery.
The Marlborough, Mass., company’s shares closed Wednesday at $17.56.