source: Boston Scientific Corporation

Boston Scientific Announces FDA Approval for Express2™ Coronary Stent System


Natick, MA (September 12, 2002) -- Boston Scientific Corporation (NYSE: BSX) announced today that it has received pre-market approval (PMA) from the U.S. Food and Drug Administration (FDA) to market its Express2™ coronary stent system. The Company plans to launch the product in the United States immediately. The Express2 coronary stent system was launched in Europe in May, and in other international markets in June.

The Express stent -- developed exclusively by Boston Scientific -- is a laser-cut, balloon-expandable stent that features a new design concept called Tandem™ Architecture. Tandem Architecture integrates short, thin Micro™ elements designed for flexibility and conformability, with long, wide Macro™ elements designed to enhance radiopacity. Combined, these elements are designed to create a structure that offers uniform vessel coverage, excellent radial strength and clean acute angiographic results.

The Express2 coronary stent system -- an Express™ stent combined with advanced Maverick® balloon catheter technology -- features a laser-bonded, flexible tip with a long, low profile designed for easier tracking. The Bioslide® hydrophilic coating is designed to reduce friction, while the proprietary Crimp 360™ technology secures the stent to the balloon.

Express stent technology has potential for future use in a broad range of applications, which may include peripheral vascular and neurovascular applications, in addition to coronary applications. The Company also plans to use the Express2 stent system as the platform for its TAXUS drug-eluting stent program.

"The combination of the Express stent with the Maverick catheter is a major step forward in stent performance," said Dr. Maurice Buchbinder, M.D., Director of the Foundation for Cardiovascular Medicine, Scripps Memorial Hospital, LaJolla, CA. "In my experience with Express2, I have found its delivery to be truly effortless."

"The Express2 offers an impressive array of features that clinicians told us they wanted, and that we designed into the product," said Paul LaViolette, Boston Scientific Senior Vice President and Group President, Cardiovascular. "We've been greatly encouraged by the positive feedback from clinicians in Europe and elsewhere. We're looking forward to similar customer satisfaction in the U.S. This is a terrific stent mounted on a highly deliverable catheter, and that's a very potent combination."

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 the regulatory approval process, commercialization of new technologies, competitive offerings, intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.


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Boston Scientific Corporation

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Boston Scientific Corporation