SVG disease occurs when saphenous veins harvested from the leg for use in coronary artery bypass graft surgery develop atherosclerosis. The FilterWire EX system is a low-profile embolic filter mounted on a guidewire that is designed to reduce complications during balloon angioplasty and stenting procedures in SVGs. It captures embolic material that becomes dislodged during cardiovascular interventions. The debris captured by the filter would otherwise travel into the microvasculature where it could cause a heart attack.

"Patients with degenerated saphenous vein grafts undergoing angioplasty and stenting are at very high risk for complications," said Gregg W. Stone, M.D. of Lenox Hill Hospital in New York. "The availability of the FilterWire EX Embolic Protection System is a major advance in our ability to safely treat these patients."

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

"The FilterWire EX system demonstrates our continued commitment to providing innovative solutions to tough clinical challenges," said Paul LaViolette, Boston Scientific Senior Vice President and Group President, Cardiovascular. "We are pleased to offer clinicians this important device because of its potential for preventing the severe complications associated with debris embolization."

Final FIRE Clinical Trial results announced
Boston Scientific also announced final results from its FIRE clinical trial, which studied the FilterWire EX system. The objective of the trial was to establish the safety and efficacy of the FilterWire EX system during balloon angioplasty or stenting procedures in the treatment of SVGs. The multi-center, randomized, controlled non-inferiority study compared the FilterWire EX product to the PercuSurge GuardWire Plus® System in a non- inferiority (equivalence) trial that enrolled 651 patients at 55 U.S. sites and four sites in Canada. The primary safety endpoint of the study was the cumulative incidence of Major Adverse Cardiac Events (MACE) defined as death, Q-wave or non Q-wave myocardial infarction, emergent coronary artery bypass surgery, or target vessel revascularization at 30 days post-procedure.

The cumulative incidence of MACE at 30 days was 9.9 percent for patients receiving treatment with the FilterWire EX system compared with 11.6 percent for patients receiving treatment with the GuardWire Plus System. The results demonstrate that the FilterWire EX system had equivalent clinical outcomes to the GuardWire Plus System.

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: www.bostonscientific.com.

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, third party intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.

GuardWire Plus is a registered trademark of PercuSurge, Inc.