Safety & Efficacy Record Of TAXUS(R) Drug-Eluting Stent Systems Reinforced

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Conferences
Article Date: 31 Aug 2006 - 0:00 PDT

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Boston Scientific Corporation (NYSE: BSX) today announced the schedule of the Company's major events and press announcements at the European Society of Cardiology/World Congress of Cardiology 2006, which runs from September 2 to 6 in Barcelona, Spain.

The Company plans to announce four-year results from the TAXUS II clinical trial. The data are expected to build on the strong body of clinical evidence supporting the continued long-term safety profile of the TAXUS(R) Express2(TM) Paclitaxel-Eluting Stent System.

"We expect the TAXUS II four-year data, which will be released at ESC, to reinforce the excellent long-term safety record of TAXUS," said Jeff Goodman, President of Boston Scientific International. "The ultimate measure of safety is the survival rate of patients, and TAXUS shows no difference in overall patient survival out to three years compared to bare metal stents. The TAXUS II four-year results should build on these positive, consistent safety outcomes, while maintaining performance benefits."

Boston Scientific will also announce six-month data from the initial phase of the OLYMPIA registry, designed to study real-world outcomes of its TAXUS(R) Liberte(TM) Paclitaxel-Eluting Stent System. The Company anticipates the data will further reinforce the safety and efficacy of its second-generation drug- eluting stent system.

In addition, the Company will host a symposium focusing on the treatment of challenging patients with drug-eluting stents, as well as separate symposia highlighting therapies in cardiac rhythm management and carotid artery disease. Details of the Company's activities at ESC/WCC are below.

Schedule of events
Tuesday, September 5 (all times are Barcelona time)

-- OLYMPIA Phase I six-month data. At 2:00 p.m., results from Phase I of the global OLYMPIA registry will be announced. The poster presentation prepared by Waqar H. Ahmed, M.D., M.S., FACC, entitled "TAXUS Liberte in the real world: six-month outcomes from the transitional phase of the TAXUS OLYMPIA post-approval registry," will be available from 2:00 p.m.

- 6:00 p.m. in the Posters Room (Zone 2) as part of a session on DES trials and registries. OLYMPIA is a prospective, multi-center, multi-phased registry with a planned enrollment of up to 27,000 patients, making it the largest study of its kind worldwide. The registry is designed to analyze real-world clinical outcomes data for Boston Scientific's next-generation TAXUS Liberte Paclitaxel-Eluting Stent System. Results from Phase I patients will focus on safety and efficacy, and highlight outcomes within the high-risk diabetic subset. The Company will also issue a press release at this time.

-- Satellite Symposium on cardiac rhythm management. At 2:00 p.m., the Company will host a satellite symposium entitled "Treatment of patients with advanced heart failure: device therapy when medications are not enough," chaired by Antonello Gavazzi, M.D., and Josep Brugada Terradellas, M.D., in the Lima Room (Zone 1). The session will address the limits of conventional therapy in treating patients with advanced heart failure, and discuss current treatment guidelines and device management.

-- Symposium on drug-eluting stents. At 4:30 p.m., the Company will host a symposium entitled "Drug-eluting stents in challenging patients," chaired by Marie-Claude Morice, M.D., and Eulogio J. Garcia Fernandez, M.D., in the Cape Town Room (Zone 1). The symposium will focus on current real world data trends related to drug-eluting stent usage in challenging, high-risk patients. The session will include a review of the long term benefits of DES treatment and a discussion of stent thrombosis.

Wednesday, September 6

-- TAXUS II long term data. At 9:00 a.m., four-year clinical follow-up results from the TAXUS II clinical trial will be presented by Antonio Colombo, M.D., the study's principal investigator, at a featured abstract session focused on long term results of drug-eluting stents, in the Cairo Room (Zone 1). TAXUS II is a randomized, double-blind, controlled study of the safety and efficacy of the 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. The Company will also issue a press release at this time.

Boston Scientific will present its latest innovations at booth J500 in the Exhibition hall. In addition, the Company will participate in the WCC public awareness initiative, "For Your Heart's Sake 2006." The event will take place September 1-2 on the Placa Catalunya in Barcelona, and is designed to educate the general public on woman's health and cardiovascular diseases through a variety of risk assessment stations and interactive demonstrations intended to promote heart healthy lifestyles. Boston Scientific will also have cardiologists available on site to answer questions.

About the World Congress of Cardiology

The World Congress of Cardiology 2006 will bring together the European Society of Cardiology (ESC) Congress 2006 and the World Heart Federation's (WHF) XVth World Congress of Cardiology. This joint meeting, in state-of-the-art facilities, will provide high quality scientific content on the latest research in cardiology and prevention and is expected to attract well over 25,000 attendees.

About Boston Scientific

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 clinical trials, the regulatory approval process, reimbursement policies, commercialization of new technologies, litigation, the Company's overall business strategy and other factors described in the Company's filings with the Boston Scientific Corporation

http://www.bostonscientific.com