FDA approves Boston Scientific's carotid artery stent

Boston Scientific Corporation has announced that the U.S. Food and Drug Administration (FDA) has approved its Carotid WALLSTENT Monorail Endoprosthesis for the treatment of patients with carotid artery disease who are at high risk for surgery.

The Carotid WALLSTENT Endoprosthesis is the leading carotid stent in Europe and other international markets. The Company said it plans to launch the product immediately in the United States.

"We are pleased to bring this proven technology to physicians in the United States," said Hank Kucheman, Senior Vice President and Group President of Boston Scientific's Cardiovascular business. "Excellent patient outcomes and ease of use in complex anatomy have already made this system the number-one stenting option for treating carotid artery disease in Europe and other countries outside the U.S. It offers a less-invasive alternative to surgery for treating carotid artery disease, and can help reduce the risk of stroke, which can have devastating effects."

The Carotid WALLSTENT is a self-expanding stent mounted on a rapid exchange delivery system, designed to re-open the carotid artery by treating stenoses, and improve blood flow to the brain. The stent features a closed-cell design, engineered for excellent lesion coverage and angiographic results. The system is designed to be highly deliverable and provide access to the toughest lesions.

It is used in conjunction with the FilterWire EZ(TM) Embolic Protection System, which is designed to capture plaque debris released during the stenting procedure, preventing it from traveling to the brain, where it could create an increased risk for stroke. The device features simplified filter sizing - accommodating vessel diameters between 3.5 mm and 5.5 mm - and offers efficient preparation, deployment and retrieval.

"The closed-cell design of the Carotid WALLSTENT Endoprosthesis is intended to provide increased scaffolding for optimal lesion coverage and a smooth inner lumen," said Barry T. Katzen, M.D., Medical Director, Baptist Cardiac and Vascular Institute, Miami. "This feature will make the Carotid WALLSTENT an attractive new treatment option for U.S. physicians and their patients."

The Carotid WALLSTENT Endoprosthesis with the FilterWire EZ System is the only carotid artery stent system approved in the United States with an indication that includes the treatment of bilateral carotid artery disease (blockages in the carotid arteries on both sides of the neck).

The carotid arteries are the main conduits through which blood flows from the heart to the brain. Carotid artery disease occurs when fatty plaque builds up inside the vessels, causing them to harden and narrow, which increases the risk of stroke. Most patients with carotid artery disease are treated with carotid endarterectomy, a surgical procedure involving an incision in the neck and removal of the plaque from the vessel walls. Carotid artery stenting is a less-invasive alternative in which a stent is delivered to the site of the blockage and expanded, forcing open the walls of the arteries and restoring blood flow.