The FDA has approved Boston Scientific’s 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 already commercially marketed in Europe and other international markets. The company said it plans to launch the product immediately in the U.S.

The Natick, Mass.-based company said its Carotid Wallstent is a self-expanding stent mounted on a rapid exchange delivery system, designed to reopen 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.