NATICK, Mass., and BARCELONA, Sept. 6 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced four-year follow-up data from its TAXUS II paclitaxel-eluting stent system clinical trial. The data demonstrated that the safety and efficacy benefits associated with the TAXUS® Stent System were maintained at four years. The Company made the announcement at the annual European Society of Cardiology/World Congress of Cardiology 2006 in Barcelona, Spain.
"The long-term results from TAXUS II speak to the remarkable effectiveness of paclitaxel-eluting technology in the treatment of coronary artery disease," said Professor Antonio Colombo, M.D., Columbus Hospital and San Raffaele Hospital in Milan, the trial's Principal Investigator. "The TAXUS II data itself is outstanding with low target lesion revascularization rates, low cardiac death rates, and no new stent thrombosis from three to four years. This technology has truly changed the way physicians treat coronary artery disease."
"We are extremely pleased with the TAXUS II results, which represent an important milestone in the evolving story of paclitaxel-eluting stent technology," said Jeff Goodman, President of Boston Scientific International. "TAXUS II is the first large-scale TAXUS clinical trial undertaken by Boston Scientific and continues to break new ground at four years. Backed by excellent long-term safety and efficacy results from TAXUS II and other TAXUS clinical trials, the TAXUS stent system continues to maintain its leadership position in the markets we serve while offering physicians and their patients a best-in-class treatment for coronary artery disease."
Excellent efficacy results
The long-term TAXUS II results suggest that the TAXUS stent system stably inhibits restenosis as demonstrated by significant reductions in TLR. TAXUS II results reported a low overall TLR rate of 7.2 percent in the slow-release formulation and 3.7 percent in the moderate-release formulation, as compared to 15.7 percent in the control group (P=0.0004), resulting in an absolute reduction of 54 percent versus control for the slow-release formulation and a 76 percent absolute reduction versus control for the moderate-release formulation. The Company has commercialized the slow-release formulation; the moderate-release formulation is not available for commercial distribution.
Outstanding long-term safety results
TAXUS II, the first TAXUS clinical trial to evaluate late clinical safety and efficacy outcomes of both the slow- and moderate-release formulations, reported no stent thrombosis from three to four years. The study also reported a low overall cardiac death rate of 1.6 percent for both the slow- and moderate-release formulations to four years, which showed no statistical difference when compared to the combined bare-metal control overall cardiac death rate of 1.5 percent. The overall myocardial infarction rate was 4.7 percent in the slow-release formulation and 5.3 percent in the moderate formulation, as compared to 6.7 in the combined control.
The TAXUS II trial is a 536-patient, 15-country, randomized, double-blind, controlled study of the safety and efficacy of a TAXUS paclitaxel-eluting coronary stent, in which two sequential cohorts of patients with standard risk, de novo coronary artery lesions were treated with different dose formulations.
Clinical follow-up in TAXUS II included 96.3 percent of the patients enrolled at four years (516/536).
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 http://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 the commercialization of new technologies, competitive offerings, intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.
CONTACT: Milan Kofol 508-650-8569 (Office) Investor Relations Boston Scientific Corporation Paul Donovan 508-650-8541 (Office) 508-667-5165 (Mobile) Media Relations Boston Scientific Corporation Charles Rudnick 508-650-8660 (Office) 617-935-1789 (Mobile) Media Relations on site at WCC Boston Scientific Corporation
SOURCE: Boston Scientific Corporation
CONTACT: Milan Kofol, Investor Relations, +1-508-650-8569, or Paul
Donovan, Media Relations, +1-508-650-8541, +1-508-667-5165 (Mobile), or
Charles Rudnick, Media Relations on site at WCC, +1-508-650-8660,
+1-617-935-1789 (Mobile), all of Boston Scientific Corporation
Web site: http://www.bostonscientific.com/