Cardiovascular surgeons in the U.S. have a new carotid artery stent in their toolbox when treating patients with carotid artery disease – a device their counterparts in Europe have had at their disposal since 1999.

The FDA has approved Boston Scientific's (Natick, Massachusetts) Carotid Wallstent Monorail Endoprosthesis for patients with carotid artery disease who are at high risk for surgery. The Wallstent is the "leading carotid stent" in Europe and other international markets, according to the company. It is a self-expanding stent mounted on a rapid exchange delivery system, designed to re-open the carotid artery by treating stenosis, and improve blood flow to the brain.

"It's a highly deliverable system, it allows the physician to place the device in very tortuous anatomy, [and] it's a low-profile design," Scott Warren, group marketing manager of Carotid Solutions at Boston Scientific, told Medical Device Daily.

Warren said there are three key differences between the Wallstent and competing devices: first, the Wallstent has the smallest free-cell area because it features a closed-cell stent design; second, it has the "unique ability to be re-constrained," he said, which allows the physician during the deployment of the device to stop, re-constrain and re-deploy the device if necessary to achieve better placement of the stent; and third, the Wallstent is the only carotid artery stent system approved in the U.S. with an indication for bilateral carotid artery disease, meaning blockages in the carotid arteries on both sides of the neck.

Warren said the Wallstent was launched in Europe in 1999, and is a "very proven technology." He said general market conditions – more specifically, the stringent regulatory conditions – is the reason the device is just now hitting the U.S. market.

"FDA requires companies like Boston Scientific to undergo very large trials for carotid artery stenting," Warren said. In this case, the BEACH trial, which enrolled patients between February 2002 and December 2003, was the large trial the company needed to prove the safety and efficacy of the Wallstent.

"The results from the BEACH trial do show the stroke rate very low, 1.7% at 30 days," he said.

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, the company noted. 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.

"We are pleased to bring this proven technology to physicians in the U.S.," said Hank Kucheman, senior VP/group president of Boston Scientific's cardiovascular business. "Excellent patient outcomes and ease of use in complex anatomy have already made this system the No. 1 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 Wallstent is used in conjunction with the FilterWire EZ 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 Katzen, MD, medical director at 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."