European ASTI study to evaluate new nitinol stent to treat carotid artery disease

NATICK, Mass., Boston Scientific Corporation has completed patient enrollment in the ASTI post-market 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. Principal Investigator of the study is Marc Bosiers, M.D., Head of the Department of Vascular Surgery, A.Z. Sint-Blasius Hospital in Dendermonde, Belgium.

The Adapt Carotid Stent features thin struts and an innovative design engineered for flexibility in the carotid arteries. It incorporates a self-expanding, rolled nitinol sheet with patented Dynamic Tapering Technology™ designed to conform to varying carotid anatomies. This second-generation carotid stent also provides excellent visibility and has a closed-cell geometry that facilitates consistent lesion coverage. It has been sold in Europe as well as other select countries since receiving CE Mark in 2010.

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

The 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.

"Physician experience with the Adapt Stent has been excellent since its introduction in Europe last year," said Jeff Mirviss, President of Boston Scientific's Peripheral Interventions Division. "It provides physicians with the flexibility, deliverability and lesion coverage needed to treat narrowing in complex carotid anatomies."

In addition to its Adapt Carotid Stent, Boston Scientific markets the Carotid WALLSTENT® Monorail® Endoprosthesis, the leading carotid stent in Europe and Japan and available in 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. Both stents are also designed to be used in conjunction with the FilterWire EZ Embolic Protection System, intended to capture plaque debris released during the stenting procedure.

"The Adapt Stent is an important addition to our portfolio of leading carotid stents in Europe," said Fred Hrkac, President of Europe, Middle East and Africa at Boston Scientific. "By offering the only CE Marked, second-generation, closed-cell carotid stent, we plan to build on the success of the Carotid WALLSTENT and continue to provide innovative treatment options for patients with carotid artery disease."

In the U.S., the Adapt Carotid Stent System is not available for sale.

Source: Boston Scientific