source: Boston Scientific Corporation

Boston Scientific Files for FDA Approval of Express™ and Express2™ Coronary Stent Systems
Company announces approvals for new cardiovascular products

Natick MA (March 17, 2002) -- Boston Scientific Corporation (NYSE: BSX) announced today it has filed an application with the U.S. Food and Drug Administration (FDA) for pre-market approval (PMA) of its Express™ coronary stent system and its Express2™ coronary stent system - rapid exchange and over-the-wire versions. (A PMA allows product commercialization in the United States.)

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 and radial strength.

The Express2 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. The Express2 stent system offers significantly greater flexibility and trackability compared to the original Express stent system that was launched in European and other international markets last September. The Company expects to launch the Express2 stent system in the United States in September and outside the United States in May. "The Express stent system technology has enormous potential, including a broad range of applications which we believe will include peripheral vascular and neurovascular, in addition to coronary applications," said Paul LaViolette, President, Boston Scientific Cardiovascular. "We also plan to use the Express2 stent system as the platform for our drug-eluting stent program. Feedback from clinicians in European and other international markets on our original Express system has been very positive. They have embraced it enthusiastically, and our European market share has doubled since its introduction six months ago. We are very excited about the prospects for the Express2 stent system. The advanced Maverick technology dramatically enhances the deliverability characteristics of the Express2 system and helps distinguish it as a marked advancement over the original Express system."

Product Approvals
The Company also announced today that it has received FDA approval or CE Mark on several new cardiovascular products, adding to its broad portfolio of medical devices:

Cutting Balloon™ Monorail™ Device
Designed for lesions resistant to dilatation with traditional angioplasty, the Cutting Balloon™ device consists of atherotomes -- or microsurgical blades -- mounted longitudinally on its outer surface. When the Cutting Balloon device is inflated, the blades score the plaque, creating localized incision sites that interrupt the elastic and fibrotic continuity of the lesion. Atherotomy relieves hoop stress by making three or four small, precisely controlled incisions. The non-compliant balloon gently dilates the incised areas resulting in plaque compression and vessel wall expansion, with reduced barotrauma. The Cutting Balloon device offers treatment flexibility because it can be used as a stand-alone treatment or in conjunction with other treatment options.

The Company has received FDA approval and launched the product earlier this month, adding to its broad cardiovascular product portfolio, which already included an over-the-wire version of the Cutting Balloon.

LP2™ Coronary Stent System
The LP2™ Coronary Stent System is an open cell stent that offers flexibility and conformability through innovative stent and balloon design.

The flexibility of the stent originates from its twin connectors and CLD™ Stent Architecture - or Continuous Loop Design. These design attributes offer the flexibility required in complex cases because the stent can bend and torque through challenging anatomy.

The performance characteristics of the Thermal™ Balloon Technology also contribute to the flexibility of the entire stent delivery system. The proprietary blend of polyurethane becomes more flexible as it warms to body temperature and provides increasing deliverability throughout the intervention.

The Company received CE Mark and launched the stent in Europe in January. A pre-market approval (PMA) application was submitted to the FDA in February.

Radius® Monorail™ Self-Expanding Coronary Stent System
The Radius® stent is the only Nitinol self-expanding coronary stent approved for use in the U.S. When the stent is exposed to body temperature, it expands and apposes itself to the vessel wall. This mode of deployment allows the stent to be implanted with much lower balloon inflation pressures than its balloon-expandable counterparts. With deployment at lower balloon inflation pressures and the ability to conform and appose itself to the coronary vessel, the Radius stent is an ideal choice for challenging clinical applications.

The Company has received FDA approval for the stent system and plans to launch in the U.S. this month.

Mach 1™ Guide Catheter
The Mach 1™ guide catheter offers precise handling, device delivery options and clinical versatility. A guide catheter is a specialized tube through which an interventional device is passed to deliver a stent, balloon or other therapy to a lesion or blockage.

Precise torque response enhances maneuverability and improved tip radiopacity allows for enhanced positioning and engagement of the guide. New braid technology combined with a unique polymer provides backup support, even in complex cases. The large lumen provides improved dye flow for better visualization and enables catheter downsizing, which may reduce entry site complications and decrease patient ambulation time.

The Company has received FDA clearance and plans to launch the 5 French, 7 French and 8 French sizes in the U.S. next month, complementing a portfolio that already includes the 6 French size.

Imager II™ Angiographic Catheter
The Imager II™ angiographic catheter offers a combination of strength, control and radiopacity. The catheter tip is highly radiopaque, making it easy to see in an angiogram. It also allows for excellent dye flow for enhanced imaging of the vessel. Soft tip material reduces risk of trauma during dye injection and a braided shaft design promotes kink resistance and deliverability for excellent advancement through tortuous anatomy.

The Company has received FDA clearance and plans to launch the device in the U.S. this month.

Ultra-thin™ SDS Balloon Dilatation Catheter
The Ultra-thin™ SDS Balloon Dilatation Catheter offers a new balloon material and new catheter technology for balloon-expandable stent delivery and balloon angioplasty.

Developed by Boston Scientific for the Ultra-thin SDS catheter, this is a unique, co-extruded non-compliant balloon material. The outer layer provides a durable, grippable surface that resists puncture and abrasion. The inner layer is thin, yet strong -- the characteristics required for low profile without compromise to dilating force.

The Company has received FDA clearance and plans to launch the product in the U.S. this month.

Biliary WALLSTENT® Endoprosthesis with Monorail™ Delivery System
The Biliary WALLSTENT® Endoprosthesis with Monorail™ Delivery System is Boston Scientific's first peripheral vascular entry into the rapid-exchange catheter, self-expanding stent market. It is the only self-expanding, .014" guidewire-based, single-operator exchange stent system designed for biliary use on the market.

The low profile design of the Biliary WALLSTENT Endoprosthesis facilitates atraumatic entry, advancement and positioning across the stricture. The proprietary, rapid exchange system allows smooth tracking to ease advancement through tortuous anatomy, and the flexible constrained stent and delivery system provide enhanced advancement to the stricture. The Biliary WALLSTENT Endoprosthesis also features a unique mesh scaffolding configuration to provide support across the stricture, and continuous, radial expansion force restores and maintains lumen patency. The Company received FDA clearance and launched the product in the U.S. in February.

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

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