Healthcare Industry News: paclitaxel
News Release - June 4, 2007
Positive Results for Second-Generation Taxus(R) Liberte(TM) Coronary Stent System Highlighted in Journal of American College of CardiologyNATICK, Mass., June 4 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today welcomed the publication of an article in the Journal of American College of Cardiology (JACC) reviewing the TAXUS ATLAS clinical trial, which evaluates the Company's second-generation TAXUS® Liberte(TM)(1) paclitaxel-eluting stent system. The article in the April 24 edition of JACC concluded that the shorter procedure time and lower bailout rate of the TAXUS Liberte Stent system compared to the TAXUS® Express2(TM) Stent system may represent a clinical surrogate for the improved deliverability and conformability of the TAXUS Liberte Stent as compared to the TAXUS Express Stent.
TAXUS ATLAS is a global, multi-center single arm trial comparing the TAXUS Liberte paclitaxel-eluting stent system to a case-matched control group of patients from the TAXUS IV and TAXUS V de novo studies that received the TAXUS Express2 paclitaxel-eluting stent system. Even with more complex lesion characteristics(2) compared to the control group, the TAXUS ATLAS trial met its primary endpoint of nine-month target vessel revascularization (TVR) non-inferiority.
The TAXUS ATLAS nine-month results also support safety, as demonstrated by low rates of Major Adverse Cardiac Events (MACE) and stent thrombosis. The MACE rate and its components, including cardiac death, myocardial infarction and TVR, were comparable to control despite the higher percentage of complex lesions for the TAXUS Liberte Stent arm. Cardiac death for the control group was 0.9 percent compared to 0.8 percent for the TAXUS Liberte Stent (p=1.00). Myocardial infarction was 3.9 percent for the control group compared to 3.7 percent for the TAXUS Liberte Stent (p=0.9030). The nine-month TVR rate for the control group was 7.1 percent compared to 8.0 percent for the TAXUS Liberte Stent (p=0.4787). Similar TVR rates of 9.2 percent for the TAXUS Liberte Stent group, as compared to 8.9 percent for the control group (p=0.83) were maintained at 12 months. In addition, nine-month stent thrombosis rates for both groups were low and similar for the TAXUS Liberte Stent (0.8 percent) and control stent (0.7 percent, p=1.0).
"ATLAS clinical outcomes highlight that despite more complex lesions, the TAXUS Liberte Stent performed extremely well and achieved similar rates of death, myocardial infarction and repeat procedures compared to an historical TAXUS Express control," said Mark Turco, M.D., FACC, FSCAI, Director of the Center for Cardiac and Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland, and co-principal investigator of the TAXUS ATLAS trial.
Data reported in the JACC article showed the TAXUS Liberte Stent was associated with significantly shorter procedural times. The study documented shorter average procedure times of 47.8 minutes for TAXUS Liberte Stent versus 53.0 minutes in the control arm (p=0.0052). The need to use additional stents due to procedural complications was reduced by nearly 50 percent in the TAXUS Liberte Stent group (3.1 percent) versus control (6.0 percent) (p=0.0038).
"The TAXUS Liberte Stent represents the latest innovation of our drug-eluting stent pipeline and we are pleased that the TAXUS ATLAS results confirm its positive performance," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "It is also further testament to the leadership of Boston Scientific that we are able to take a proven drug like paclitaxel and successfully transition it to an even more deliverable platform such as the Liberte Stent."
The Company received the CE Mark for the TAXUS Liberte stent in Europe and other international markets in September 2005, and it is currently the market-leading drug-eluting stent outside the United States. The TAXUS Liberte stent is currently pending approval by the U.S. Food and Drug Administration and is not available for sale in the United States.
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. Boston Scientific 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 product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
(1) The TAXUS Liberte stent is currently pending approval by the U.S. Food and Drug Administration and is not available for sale in the United States.
(2) Defined as B2 or C lesions (ACC/AHA lesion type)
Source: Boston Scientific
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