source: Boston Scientific Corporation

Boston Scientific Announces CE Mark
for Symbiot™ Covered Stent System
SYMBIOT II clinical trial results reported at PCR

Natick, MA (May 28, 2002) -- Boston Scientific Corporation (NYSE: BSX) announced today that it has received the CE Mark for its Symbiot™ Covered Stent System and will begin immediate commercialization of the product in Europe. The Symbiot Covered Stent is specifically designed to address the two major limitations of treating saphenous vein graft (SVG) disease: the risk of plaque embolization during the procedure and poor long-term outcomes. Developed exclusively by Boston Scientific, the Symbiot Covered Stent System features a self-expanding nitinol stent encased in a thin porous ePTFE polymer membrane. The ePTFE cover and self-expanding deployment are intended to work together to reduce plaque embolization during the stenting procedure and provide a long-term patient benefit by reducing restenosis.

Each year, an estimated 600,000 coronary artery bypass graft surgeries are performed worldwide to relieve angina in patients suffering from coronary artery disease. The surgery is designed to detour blood around a narrowed artery in order to restore adequate blood flow to the heart. Frequently, saphenous veins are harvested from the leg and used as grafts in this surgery. Within a decade, most SVGs will have developed severe atherosclerosis. These patients are often treated in the cardiac catheterization laboratory, and stent implantation has become standard therapy due to the limited success of balloon angioplasty for use in obstructed SVGs. However, conventional stents are not specifically designed for treating this disease and are often associated with procedural embolization and high restenosis rates. The Symbiot Covered Stent System has significant potential for improving outcomes for the estimated 250,000 patients who are affected by SVG disease worldwide each year.

"The Symbiot Covered Stent System is an exciting technological advancement that we believe will benefit people affected by SVG disease as well as the physicians who treat them," said Paul LaViolette, Boston Scientific Senior Vice President and Group President, Cardiovascular. "It provides an innovative solution to a challenging clinical situation with the potential to improve patient outcomes."

Last week at the Paris Course on Revascularization, the largest interventional cardiology conference in Europe, Boston Scientific announced results for its SYMBIOT II clinical trial. SYMBIOT II was an international, multi-center, prospective, non-randomized clinical study involving 77 patients to support product commercialization in Europe. SYMBIOT II was designed to assess the safety of the Symbiot Covered Stent System in the treatment of patients with SVG disease, which was demonstrated in this trial.

"We have found very low incidences of adverse clinical events, distal embolization of debris, and angiographic restenosis in patients treated in the SYMBIOT II trial," said Dr. GertJan Laarman, Principal Investigator for the SYMBIOT II trial. "The results of this trial demonstrate that treatment of de novo and restenotic saphenous vein graft lesions with the Symbiot Covered Stent System may provide for improved vessel patency and clinical outcomes over time."

SYMBIOT III, a randomized U.S. clinical trial involving up to 50 institutions and up to 700 patients, is currently underway to evaluate the safety and efficacy of the Symbiot Covered Stent System for the treatment of SVG disease. The Company expects to commercialize the device in the U.S. in early 2004.

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.


Contacts  
Milan Kofol (508-650-8569)
Investor Relations
Boston Scientific Corporation

Paul Donovan (508-650-8541)
Media Relations
Boston Scientific Corporation