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 patient in the ARRIVE 2 registry yesterday. Other physicians are scheduled to enroll patients this week.
"ARRIVE 2 continues the real-world study of the TAXUS stent system in the U.S. and further demonstrates Boston Scientific's commitment to safety," said Dr. Cox. "By enrolling consecutive patients, we are able to see how the TAXUS stent performs in a wide-range of complex cases that represent more realistically what physicians face on a day-to-day basis."
ARRIVE 2 is the follow-on registry to ARRIVE, a peri-approval registry that has enrolled nearly 2,600 consecutive patients at 50 centers in the United States (a peri-approval registry includes patients who are enrolled before and after a product is approved). ARRIVE was the first TAXUS registry in the United States. The Company announced results at the Transcatheter Cardiovascular Therapeutics conference in September that showed ARRIVE demonstrated safety based on a site-reported 30-day cardiac event rate of 2.7 percent (70/2,582), including site-reported cardiac death, myocardial infarction and reintervention of the target vessel. The registry also reported a stent thrombosis rate of 1.3 percent (angiographically confirmed thrombotic events and all deaths less than 30 days without obvious cause) at 30 days. ARRIVE reported a 99 percent follow-up at 30 days.
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.