Boston Scientific Submits IDE to FDA for Its New Express Coronary Stent

Company Expects First Human Implant in May



Apr 11, 2001, 01:00 ET from Boston Scientific Corporation

    NATICK, Mass., April 11 /PRNewswire/ -- Boston Scientific Corporation
 (NYSE:   BSX) today announced that it submitted an application to the U.S. Food
 and Drug Administration for an Investigational Device Exemption (IDE) of its
 internally developed Express coronary stent.  Initiation of clinical trials in
 the United States could begin as early as next month.
     Boston Scientific's clinical study plan, which is subject to FDA approval,
 is expected to enroll 450 patients at 25 sites throughout the U.S.  It is
 designed to demonstrate the safety and efficacy of the device for use in
 elective coronary stenting and for the treatment of abrupt closure/threatened
 abrupt closure (AC/TAC).
     The Express stent is the company's newest internally developed coronary
 stent, mounted on one of Boston Scientific's market-leading catheters.  It is
 designed to provide outstanding performance by optimizing flexibility,
 deliverability and scaffolding characteristics.
     "The submission of the IDE represents the achievement of a significant
 milestone in the development of Boston Scientific's coronary stent program,"
 said Jim Tobin, President and Chief Executive Officer of Boston Scientific.
 "This achievement brings us a large step closer to being able to provide
 physicians with a new stent platform that is highly deliverable.  Our teams
 working on this project deserve enormous credit for the impressive progress
 they have made in such a short period of time."
     Boston Scientific is a worldwide developer, manufacturer and marketer of
 medical devices.  The company's 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 that actual results may differ from those
 discussed in the forward-looking statements and may be adversely affected by,
 among other things, risks inherent in commercialization of emerging
 technologies, physician acceptance of new products, competitive offerings and
 other factors described in the Company's filings with the Securities and
 Exchange Commission.
 
 

SOURCE Boston Scientific Corporation
    NATICK, Mass., April 11 /PRNewswire/ -- Boston Scientific Corporation
 (NYSE:   BSX) today announced that it submitted an application to the U.S. Food
 and Drug Administration for an Investigational Device Exemption (IDE) of its
 internally developed Express coronary stent.  Initiation of clinical trials in
 the United States could begin as early as next month.
     Boston Scientific's clinical study plan, which is subject to FDA approval,
 is expected to enroll 450 patients at 25 sites throughout the U.S.  It is
 designed to demonstrate the safety and efficacy of the device for use in
 elective coronary stenting and for the treatment of abrupt closure/threatened
 abrupt closure (AC/TAC).
     The Express stent is the company's newest internally developed coronary
 stent, mounted on one of Boston Scientific's market-leading catheters.  It is
 designed to provide outstanding performance by optimizing flexibility,
 deliverability and scaffolding characteristics.
     "The submission of the IDE represents the achievement of a significant
 milestone in the development of Boston Scientific's coronary stent program,"
 said Jim Tobin, President and Chief Executive Officer of Boston Scientific.
 "This achievement brings us a large step closer to being able to provide
 physicians with a new stent platform that is highly deliverable.  Our teams
 working on this project deserve enormous credit for the impressive progress
 they have made in such a short period of time."
     Boston Scientific is a worldwide developer, manufacturer and marketer of
 medical devices.  The company's 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 that actual results may differ from those
 discussed in the forward-looking statements and may be adversely affected by,
 among other things, risks inherent in commercialization of emerging
 technologies, physician acceptance of new products, competitive offerings and
 other factors described in the Company's filings with the Securities and
 Exchange Commission.
 
 SOURCE  Boston Scientific Corporation