Boston Scientific Announces FDA Clearance for Express® Biliary SD Monorail® Premounted Stent System
(April 19, 2004) -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Express® Biliary SD Monorail® Premounted Stent System for the treatment of malignant biliary tumors. The Company said it will launch the stent system in the U.S. immediately.

The Express Biliary SD Stent System combines features from two of Boston Scientific's breakthrough technologies, the Express stent and the Maverick® balloon catheter. The new device offers increased scaffolding at the proximal end of the stent, enhanced delivery and precise placement.

The stent system features "6F" guide catheter compatibility and improved tracking to enhance deliverability. Minimal stent shortening and customized balloon lengths for each stent length are designed to enable accurate placement, while the increased stent scaffolding at the proximal end provides lumen support.

"This product combines two Boston Scientific proprietary technologies to create a first-class stent system for treating diseases of the biliary tree," said Matthew Jenusaitis, President of Boston Scientific's Peripheral Interventions business. "The stent and balloon combination provides excellent trackability and deliverability, without compromising stent radial strength."

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:

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 litigation, clinical trials, the regulatory approval process, reimbursement policies, commercialization of new technologies, intellectual property, and other factors described in the Company's filings with the Securities and Exchange Commission.