A Medical Device Daily

Boston Scientific (Natick, Massachusetts) yesterday reported that it has received FDA clearance to market its FilterWire EZ Embolic Protection System for use in carotid artery stenting (CAS) procedures. The device was cleared by the FDA in August 2004 for use in coronary saphenous vein graft (SVG) interventions and the company says it is currently the market-leading embolic protection device for CAS outside the U.S.

The FilterWire EZ System is designed to capture plaque and other embolic material that may dislodge during stent implantation and prevent it from traveling into the microvasculature where it could stroke or heart attack. The device features simplified filter sizing — one size can be placed in vessel diameters between 3.5 mm and 5.5 mm — and is designed for easy preparation, delivery and retrieval.

The FilterWire EZ System was evaluated in the CABERNET Trial in conjunction with the recently approved NexStent Carotid Stent and Monorail Delivery System. With the new carotid indication, the FilterWire EZ Embolic Protection System can now be used in the U.S. to treat patients with carotid artery disease who are at high risk for surgery.

John Pedersen, president of Boston Scientific’s Peripheral Interventions business, said, “With its second cleared indication, the FilterWire EZ System offers innovation and versatility to treat a variety of lesions and cases seen in every day practice.”

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