Navigation Links
Taxus VI Clinical Trial Demonstrates Positive Long-Term Outcomes,for Moderate-Release Paclitaxel-Eluting Stent at Four Years

Trial results report no new stent thrombosis after two years in high-risk patient population

NATICK, Mass., and BARCELONA, Spain, May 22, 2007 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced four-year follow-up data from its TAXUS VI clinical trial. The data demonstrated that the safety and efficacy benefits associated with a moderate-release formulation of the TAXUS(R) Express(TM) paclitaxel-eluting stent system -- which is not approved for commercial distribution -- were maintained at four years with no new stent thrombosis reported after two years. Analysis of the data was presented by Professor Eberhard Grube, M.D., Heart Center Siegburg, Germany, the Co- Principal Investigator of the trial. The Company made the announcement at the annual Paris Course on Revascularization (EuroPCR) in Barcelona.

"Even though the moderate-release TAXUS formulation, with an 8-10 fold higher in vitro dose, was never commercialized, the excellent ongoing results in TAXUS VI further demonstrate the margin of safety of the commercial slow- release TAXUS stent now implanted in more than four million patients worldwide," said Paul LaViolette, Boston Scientific Chief Operating Officer. "With no stent thrombosis after two years, a low cardiac death rate, and a low TLR rate, we continue to be impressed with how paclitaxel performs in this high-risk patient population."

"The four-year results from TAXUS VI demonstrate that the safety and efficacy benefits associated with the moderate-release TAXUS paclitaxel- eluting stent system were maintained in patients with complex coronary artery disease at four years," said Professor Grube. "The performance of the TAXUS stent in these patients was extremely impressive when considering the complexity of their disease, including patients with long lesions, small vessels, and those requiring multiple, overlapping stents."

The randomized, double-blind, co ntrolled study of 446 patients at 44 international sites is designed to assess the TAXUS moderate-release paclitaxel-eluting coronary stent system in reducing restenosis in high-risk patients, including de novo lesions with overlapping stents, lesions 26 mm or greater in length and small vessels. Lesion size ranged from 18 - 40 mm in length and 2.5 - 3.75 mm in diameter. TAXUS VI is the first randomized, controlled clinical trial to demonstrate durability of drug-eluting stents in complex lesions at four years. Follow-up included 98 percent of the patients enrolled at four years.

The study's results demonstrate a continued significant reduction in target lesion revascularization (TLR, or retreatment rate) as compared to the bare-metal stent control group at four years. The four-year TLR rate was 12.9 percent for the TAXUS Stent group, as compared with 21.4 percent for the control group (P=0.0082 (only two TLR events were reported between three and four years for the TAXUS Stent group)). The rate of patients living free of TLR events was 87.1 percent at four years for the TAXUS Stent group, as compared to 78.6 percent for the bare-metal stent control group.

The four-year results for TAXUS VI support long-term safety with the increased levels of paclitaxel in the moderate-release formulation used in the study. Even with an in vitro dosing rate 8-10 times greater than the commercialized slow-release formulation, no compromise in safety was observed. The TAXUS Stent group continues to report no new stent thrombosis after two years with a low 2.4 percent cardiac death rate.

Boston Scientific launched the slow-release formulation TAXUS Express2 paclitaxel-eluting coronary stent system in Europe and other international markets in 2003 and in the United States in 2004. The Company launched the slow-release formulation TAXUS(R) Liberte(TM) paclitaxel-eluting coronary stent system in Europe and other international markets in 2005. The TAXUS Express modera te-release paclitaxel-eluting stent is not approved for commercial distribution.

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 new 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.


    CONTACT:  Paul Donovan

              508-650-8541 (office)

              508-667-5165 (mobile)

              Media Relations

              Boston Scientific Corporation


              Dan Brennan

              508-650-8538 (office)

              617-459-2703 (mobile)

              Investor Relations

              Boston Scientific Corporation

Boston Scientific Corporation

CONTACT: Media Relations, Paul Donovan, +1-508-650-8541, mobile,+1-508-667-5165, Investor Relations, Dan Brennan, +1-508-650-8538, mobile,+1-617-459-2703, both of Boston Scientific Corporation

Web site: http://www.bostonscientific.com/

Ticker Symbol: (NYSE:BSX)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. New Study Suggests Better Patient Outcomes with CYPHER Sirolimus-Eluting Coronary Stent than with Taxus Stent in Real-World Clinical Settings
2. Positive Results for Second-Generation Taxus Liberte Coronary Stent System Highlighted in Journal of American College of Cardiology
3. SPIRIT Clinical Data Reaffirm Strength of Taxus and Promus Drug-Eluting Coronary Stent Systems
4. Abbotts Xience V Everolimus Eluting Coronary Stent Superior to Taxus Stent in Spirit III U.S. Pivotal Clinical Trial
5. Genetic Analysis Systems Enter the Clinical Mainstream
6. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
7. Large Geographic Differences in EpiPen Prescriptions in the U.S., From the Journal of Allergy and Clinical Immunology
8. Clinical Data Suggest Decreased Bleeding Risk in People With Severe Hemophilia A While Maintaining Factor VIII Levels Above One Percent
9. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
10. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
11. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... Oct. 11, 2017  BioPharmX Corporation (NYSE MKT: BPMX) ... developed an innovative way to use nonlinear optical imaging ... of new drugs. ... Conference will show how researchers from BioPharmX and the ... School used a suite of imaging techniques in what ...
(Date:10/10/2017)... , Oct. 10, 2017  NDS received FDA 510(k) clearance in ... medical-grade battery-powered display stand specifically designed for endoscopy environments. An innovative ... into a clinical solution to support the improvement of patient outcomes, ... Design ... Solution ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 2017 , ... Coveros, a leader in agile coaching services ... by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile Transformation ... Agile methodologies in a consistent and high value manner across CMS programs. Coveros ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... for healthcare compliance program management, will showcase a range of technology and learning ... Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 at ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has developed ... consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every formula has ... highest standard. , These products are also: Gluten Free, Non-GMO, Vegan, Soy ...
(Date:10/12/2017)... ... ... Asante, a nationally recognized health system in southern Oregon, ... health joint venture through an agreement, effective October 1, 2017, to create AccentCare ... company with Asante, delivering clinically integrated care, for the past eight years. This ...
(Date:10/12/2017)... ... 12, 2017 , ... HMP , a leader in healthcare events and ... Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie ... annual award competition recognizes editorial and design excellence across a range of sectors. This ...
Breaking Medicine News(10 mins):