Boston Scientific Completes Enrollment of Carotid Stenting Clinical Trial
(January 16, 2004) -- Boston Scientific Corporation (NYSE: BSX) announced today that it has completed enrollment of a clinical trial to evaluate the benefits of stenting - in conjunction with embolic protection - to treat carotid artery disease. The clinical trial is using the Company's FilterWire EZ™ Embolic Protection System and Carotid Wallstent® Monorail® Endoprosthesis to treat patients who are at high risk for the surgical treatment of carotid endarterectomy.

The single-arm clinical trial, known as BEACH, is a prospective, non-randomized trial enrolling 747 patients at 47 sites across the United States. There are 480 patients studied in the pivotal phase of the trial.

"We are extremely optimistic that this trial will demonstrate the safety and efficacy of these devices," said Paul LaViolette, Senior Vice President and Group President, Cardiovascular. "Ultimately, we believe the Company's carotid stenting system will provide an innovative, less-invasive treatment option for physicians and their patients."

"We are pleased to complete the enrollment phase of this landmark trial," said Christopher White, M.D., Chairman of the Department of Cardiology and Director of the Ochsner Heart and Vascular Institute in New Orleans, and a Co-Principal Investigator of the BEACH trial. "The device combination is highly compatible and facilitates delivery."

"This trial involving high surgical risk patients represents another major step in the advancement of carotid stenting as a therapeutic alternative for patients with carotid occlusive disease," said Sriram Iyer, M.D., Chief of Endovascular Services at the Lenox Hill Heart and Vascular Institute in New York City, and a Co-Principal Investigator of the trial.

The carotid arteries, located on either side of the neck, are the main conduits for blood flow to the brain. When narrowing occurs, patients become at risk for stroke. Stroke is the nation's third leading cause of death, killing nearly 160,000 Americans every year.

The FilterWire EZ Embolic Protection System, Boston Scientific's next-generation FilterWire system, is a low-profile filter mounted on a rapid exchange deployment system designed to capture embolic debris that is released during a procedure and 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 Endoprosthesis 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. Both devices have been granted CE Mark and are commercially available in Europe and other international markets.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit:

This press release contains forward-looking statements. The Company wishes to caution the reader of this press release 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, the regulatory approval process, commercialization of new technologies and other factors described in the Company's filings with the Securities and Exchange Commission.