The TAXUS V clinical trial expands on the TAXUS IV trial, which established the safety and efficacy of the TAXUS™ Express2™ paclitaxel-eluting stent system. TAXUS V is studying a higher-risk patient population than TAXUS IV. Final results are expected in early 2005, when the nine-month follow-up data have been analyzed.
Although the TAXUS V data remain blinded, preliminary safety data indicate that event rates for all safety parameters - including stent thrombosis - are within the acceptable range seen in all other TAXUS clinical trials, despite the higher-risk patient population.
"The lesions enrolled in TAXUS V are some of the most challenging we face as interventional cardiologists," said Gregg Stone, M.D., Principal Investigator of TAXUS V and Director, Cardiovascular Research and Education, The Cardiovascular Research Foundation at the Lenox Hill Heart and Vascular Institute in New York. "We are hopeful that the outcomes of TAXUS V in this higher-risk patient population will extend the results from TAXUS IV, broadening the range of patients who may benefit from this breakthrough technology."
The TAXUS V ISR (in-stent restenosis) trial is an independent trial evaluating outcomes in patients who have developed narrowing in a bare-metal stent. This trial continues to enroll patients.
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.