The ARRIVE registry has enrolled 2,589 consecutive patients at 50 sites in the United States. A registry program enlists large numbers of clinicians to document the performance of a specific therapy for a particular disease or condition. A peri-approval registry includes patients who are enrolled before and after a product is approved. The ARRIVE registry was initiated in cooperation with the U.S. Food and Drug Administration (FDA). The Company expects to announce 30-day results at the 2004 Transcatheter Cardiovascular Therapeutics conference in September.
"We are pleased to have completed enrollment of this important registry following FDA approval of our TAXUS system," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "The speed with which we completed enrollment is impressive and speaks to the enthusiasm for this revolutionary technology within the U.S. physician community."
"ARRIVE is the first TAXUS registry in the United States and will provide us with important real-world data," said John Lasala, M.D., Ph.D., of Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis and Co-Principal Investigator of ARRIVE. "One of the distinguishing aspects of this registry is that we have enrolled consecutive patients. This will give us an opportunity to examine how the TAXUS system performs in a variety of challenging lesions and patient subsets."
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: www.bostonscientific.com.
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, third party intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.