Healthcare Industry News: Liberte
News Release - May 16, 2006
TAXUS ATLAS Trial Supports Excellent Deliverability and Proven Outcomes of TAXUS(R) Liberté(TM) stent system
Boston Scientific's Second Generation Stent Compares Favorably to Market Leading TAXUS Express2(TM) Stent System, Even With More Complex LesionsNATICK, Massachusetts and PARIS, France, May 16 (Healthcare Sales & Marketing Network) - Boston Scientific Corporation (NYSE: BSX ) today announced nine-month data from its TAXUS ATLAS clinical trial. The results confirmed safety and efficacy and demonstrated the excellent deliverability of the TAXUS(R) Liberté(TM) paclitaxel-eluting stent system compared to the TAXUS Express(TM) and TAXUS Express2(TM) paclitaxel- eluting stent system. The Company made the announcement at the annual Paris Course on Revascularization (EuroPCR) held this week in Paris.
"The TAXUS ATLAS trial expands one of the largest DES data collections and extends the consistent clinical outcomes seen in the TAXUS clinical program to a new stent platform," said Mark A. Turco M.D., F.A.C.C., Director, Center for Cardiac and Vascular Research, Washington Adventist Hospital, Takoma Park, MD, and trials co-principle investigator. "The TAXUS Liberte stent provides improved deliverability and conformability and the ATLAS trial results support excellent performance in complex lesions more consistent with evolving clinical practice patterns."
The TAXUS ATLAS trial is a global, multi-center pivotal study comparing the TAXUS Liberté paclitaxel-eluting stent system to a case-matched control group of patients from the TAXUS IV and TAXUS V de novo studies who received respectively the TAXUS Express (1) and TAXUS Express2 paclitaxel-eluting stent system. The trial met its primary endpoint of nine-month target vessel revascularization (TVR), a measure of the effectiveness of a coronary stent in reducing the need for a repeat procedure. The nine-month TVR rate for the TAXUS Liberté stent was 8.0 percent. The study also reported a target lesion revascularization (TLR) rate of 5.7 percent for the TAXUS Liberté stent.
The TAXUS Liberté stent patients presented with more complex lesions compared to the control group. The percent of ACC/AHA B2/C lesions was 75.5 percent compared to 61.2 percent in the control patients (p less than 0.0001). Lesion characteristics for the TAXUS Liberté stent patients showed significant differences (increases) in measures of length, bend, tortuosity and calcification compared to the control patients. Even with more complex lesions, the TAXUS Liberté stent was associated with significantly shorter procedural times. The study documented shorter average procedure times of 47.8 minutes for TAXUS Liberté stent versus 53.0 minutes in the control patients (p(equal sign)0.0052). In addition, the need to use additional stents due to procedural complications was reduced by nearly 50 percent in the TAXUS Liberté stent patients (3.1 percent) versus control (6.0 percent).
The TAXUS ATLAS nine-month results also support safety, as demonstrated by low rates of Major Adverse Cardiac Events (MACE) and stent thrombosis. All factors of MACE, including cardiac death, myocardial infarction, TVR and TLR were comparable to control, despite the higher percentage of complex lesions for the TAXUS Liberté stent patients. In addition, stent thrombosis rates were statistically comparable between TAXUS Liberté (0.8 percent or 7/858 patients) and control stents (0.7 percent or 7/966 patients), indicating comparable safety of the TAXUS Liberté stent.
"The TAXUS Liberté paclitaxel-eluting stent system represents the latest innovation of our drug-eluting stent pipeline and we are pleased that these results confirm its advantages, especially with respect to deliverability and ease of use" said Paul LaViolette, Chief Operating Officer of Boston Scientific. "The TAXUS stent system leads in virtually every market where we do business, and the results of this study demonstrate that TAXUS stents are positioned to remain the industry leader and the drug-eluting stent of choice."
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. 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 new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
TAXUS Liberté is contraindicated in patients with heavily calcified lesions
(1) TAXUS Express stent is investigational only and not available for sale
Source: Boston Scientific
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