In its notification letter to Boston Scientific, the FDA stated that the TAXUS product may represent "a breakthrough technology," which offers an alternative to current FDA-approved technologies for treating coronary artery disease.

"This designation represents further progress for our drug-eluting stent program," said Boston Scientific President and Chief Executive Officer Jim Tobin. "Our TAXUS launch in Europe and other international markets is going well, and we're continuing to work toward a U.S. launch late this year."

Although expedited review status does not guarantee a faster approval from the FDA, it ensures that FDA resources are assigned to the review as a priority.

The TAXUS clinical program is a series of studies designed to collect data on Boston Scientific's proprietary polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis, the growth of neointimal tissue within an artery after angioplasty and stenting. Prior studies have demonstrated promising results by dramatically reducing restenosis. The proprietary polymer on the stent allows for controlled delivery of paclitaxel. Paclitaxel is a multi-functional microtubular inhibitor that controls platelets, smooth muscle cells and white blood cells, all of which are believed to contribute to restenosis. The Company initiated the TAXUS program in 1997.

The TAXUS I trial confirmed safety and reported zero thrombosis and zero restenosis. The TAXUS II trial studied the treatment of de novo coronary lesions and demonstrated both safety and efficacy using the slow- and moderate-release formulations. Significant improvements were seen for clinical, angiographic and intravascular measures of stent performance compared with the bare control stent. The TAXUS III trial, which studied the treatment of in-stent restenosis, confirmed safety and reported no thrombosis. The TAXUS IV trial has completed enrollment and nine-month follow-up is underway. TAXUS VI is studying patients with complex coronary artery disease and has completed enrollment. Boston Scientific has also initiated a transitional registry program (WISDOM) in a number of countries as part of a limited commercial launch of its TAXUS paclitaxel-eluting stent system. A European post-market registry (Milestone II) is expected to begin soon following the recent European commercialization of the TAXUS product. The TAXUS system is the subject of an Investigational Device Exemption and is not currently available for commercial distribution in the United States.

The TAXUS product uses the Express2™ coronary stent system as its platform. The system offers excellent deliverability to the treatment site and outstanding conformability to the vessel wall.

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, competitive offerings, and other factors described in the Company's filings with the Securities and Exchange Commission.