The procedure was performed at the Arizona Heart Institute and Foundation in Phoenix. Boston Scientific recently received FDA approval to enroll as many as 775 patients in the trial, at up to 40 sites across the United States. The FilterWire EX embolic protection device is a low-profile filter -- mounted on a rapid exchange deployment system -- designed to capture embolic debris that is released during a procedure to prevent it from traveling to the brain, where it could cause a stroke. The device is removed at the end of the procedure.

The Carotid Wallstent Monorail device is a self-expanding stent mounted on a rapid exchange deployment system, designed to open the carotid artery and improve blood flow to the brain.

"We are excited to begin enrolling patients in this important trial," said Sri Iyer, M.D., of Lenox Hill Hospital in New York City, Principal Investigator of the trial, known as 'Boston Scientific/EPI: A Carotid Stenting Trial for High Risk Surgical Patients' (BEACH). "The FilterWire EX device in combination with the Carotid Wallstent Monorail device represents a potential major advance in carotid stenting."

"Embolic protection is critical to the successful outcome of a carotid stenting procedure," said Christopher White, M.D., Chairman, Department of Cardiology and Director, Ochsner Heart and Vascular Institute in New Orleans, also Principal Investigator of the BEACH trial. "Combining the FilterWire EX embolic protection device and the Carotid Wallstent Monorail device is designed to offer significant clinical value, through the Monorail™ delivery advantage and the compatibility of the devices."

"The FDA's approval of this trial, and the first U.S. patient case using the FilterWire EX and Carotid Wallstent Monorail as a system, mark an important phase in our on-going commitment to leadership in carotid endovascular therapy," said Paul LaViolette, President, Boston Scientific Cardiovascular. "We hope to demonstrate the safety and efficacy of this system in order to provide a less-invasive treatment option to people who are at risk for carotid artery disease." Carotid arteries, located on either side of the neck, are the main conduit for blood flow to the brain. When narrowing occurs, patients are at risk for stroke. Stroke is the nation's third leading cause of death, killing nearly 160,000 Americans every year.

The FilterWire EX and the Carotid Wallstent Monorail each has been granted CE Mark and have been on the market in Europe for more than a year.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

This press release contains forward-looking statements. The Company wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, regulatory approvals, commercialization of new technologies and other factors described in the Company's filings with the Securities and Exchange Commission.