In cooperation with the U.S. Food and Drug Administration (FDA), the ARRIVE registry has been initiated prior to FDA approval of the TAXUS system. The registry will continue post-approval. The Company expects approval of the TAXUS system during the first quarter of this year.
The registry's Co-Principal Investigators are David Cox, M.D., of Mid Carolina Cardiology in Charlotte and John Lasala, M.D., Ph.D., of Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis.
Dr. Cox enrolled the first patients in the ARRIVE registry today. Other physicians are scheduled to enroll patients this week.
"The ARRIVE registry demonstrates our continued commitment to safety and rigorous science in the TAXUS program," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We were pleased to work closely with the FDA on the design of this study, and we feel it is an essential part of bringing the benefits of the TAXUS technology to patients in the United States."
"This is the first real-world study of the TAXUS stent system in the U.S.," said Dr. Cox. "It will provide important information on the safety and performance of this new technology."
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, litigation, intellectual property, and other factors described in the Company's filings with the Securities and Exchange Commission.