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news.Boston Scientific has announced that the FDA has approved its carotid Wallstent Monorail endoprosthesis for the treatment of patients with carotid artery disease who are at high risk for surgery.
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The company said that it plans to launch the product immediately in the US market.
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 company said.
It 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, added Boston Scientific.
Hank Kucheman, senior vice president and group president of Boston Scientific’s cardiovascular business, said: “We are pleased to bring this proven technology to physicians in the US. 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 US.”