Enrollment Completed in European Postmarket Trial for Boston Scientific's Adapt Monorail Carotid Stent System

July 12, 2011—Boston Scientific Corporation (Natick, MA) announced that it has completed patient enrollment in the ASTI postmarket clinical follow-up study designed to evaluate its Adapt Monorail carotid stent system in combination with its FilterWire EZ embolic protection system for treatment of carotid artery disease in patients at high risk for carotid surgery. The trial began in 2010 and has reached its enrollment goal of 100 patients at 11 sites in Europe.

According to the company, the ASTI study will examine rates of major adverse events, defined as any death, stroke, or myocardial infarction at 30 days. Additionally, it will assess rates of late ipsilateral stroke, target lesion revascularization, and in-stent restenosis. Marc Bosiers, MD, is Principal Investigator of the study.

“The Adapt stent offers outstanding deliverability and scaffolding of the vessel wall, which are critical attributes for carotid stents,” commented Dr. Bosiers. “I look forward to seeing how the features of this new technology may be reflected in clinical outcomes from the ASTI study.”

Boston Scientific stated that the Adapt Monorail carotid stent is designed with thin struts and a closed-cell geometry to provide consistent lesion coverage, flexibility, and visibility. It incorporates a self-expanding, rolled nitinol sheet with the company's Dynamic Tapering Technology to conform to varying carotid anatomies. The Adapt is Boston Scientific's second-generation carotid stent. It has been available in Europe and other select countries since receiving CE Mark in 2010. The company advised that the Adapt carotid stent system is not available for sale in the United States.

The company's carotid Wallstent Monorail endoprosthesis is available in the United States, Europe, Japan, and all major markets worldwide. Both stents are mounted on Monorail delivery systems and feature closed-cell designs intended to offer increased scaffolding of the vessel wall. The Adapt and the Wallstent devices are designed to be used with the FilterWire EZ embolic protection system.