The results reflect findings involving 587 patients -- 304 in the FilterWire EX device arm and 283 in the PercuSurge GuardWire Plus® device control arm. The multi-center, randomized, controlled non-inferiority study was conducted at 55 sites in the United States and 4 sites in Canada. The primary safety endpoint of the study was the cumulative incidence of MACE (Major Adverse Cardiac Events) defined as death, Q wave or non-Q wave myocardial infarction (MI), emergent coronary artery bypass surgery (CABG), or target vessel revascularization (TVR) at 30 days post-procedure.

The cumulative incidence of MACE at 30 days was 9.5 percent for patients in the FilterWire EX device arm compared with 11 percent for patients in the arm incorporating the GuardWire Plus device. These results yielded a highly significant non-inferiority cohort p value of 0.0029, establishing the FilterWire EX device as non-inferior to the benchmark PercuSurge GuardWire Plus embolic protection device for SVGs. The GuardWire Plus device from Medtronic AVE, was studied in the SAFER trial and resulted in a 42 percent reduction in MACE in SVG disease versus no protection, providing a statistically significant advantage over no protection.

"The FIRE trial results are proof of Boston Scientific's commitment to providing new, innovative and less-invasive therapies," said Paul LaViolette, Boston Scientific Senior Vice President and Group President, Cardiovascular. "Saphenous vein graft disease is a critical application for the FilterWire EX device because the grafts are often diffuse with friable atherosclerosis. We're confident the device will become an important tool for physicians in treating this challenging indication."

Embolic protection has traditionally been addressed in two ways -- pharmaceutically which impacts blood clotting but does not address debris embolization, and with protection devices that actually capture debris.

"The use of distal protection devices during angioplasty and stenting in saphenous vein grafts offers a major breakthrough in the safe and effective treatment of these high-risk patients," said Dr. Stone. "The FilterWire EX device significantly enhances ease of use while maintaining blood flow."

Boston Scientific has been granted CE Mark in Europe for the FilterWire EX Embolic Protection Device for use in peripheral, coronary and carotid vessels. The Company submitted a pre-market notification to the FDA on November 1 for an SVG indication and plans to commercialize the device in the United States in the spring of 2003 pending FDA clearance.

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 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.

GuardWire Plus is a registered trademark of PercuSurge, Inc.