Boston Scientific to Release Broad Range of Clinical Trial Data Reinforcing Safety and Efficacy of Taxus Coronary Stent Systems at TCT 2007
NATICK, Mass., October 16, 2007 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced the schedule of the Company's major events and press announcements at the Cardiovascular Research Foundation's (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, which runs from October 20 to 25 in Washington, D.C.
Boston Scientific will be announcing a wide range of safety and efficacy data on its market-leading TAXUS(R) Express2(TM) and TAXUS(R) Liberte(R) Paclitaxel-Eluting Stent Systems, including final five-year results from the TAXUS IV clinical trial, which studies the TAXUS Express(TM) Stent, and nine- month data on small vessels and long lesions from the ATLAS trial, which studies the TAXUS Liberte Stent. In addition, the Company will present long- term data from the TAXUS V de novo clinical trial and the TAXUS ARRIVE registry.
"The extensive data to be presented at TCT will continue to reinforce the safety, efficacy and deliverability of the TAXUS Stent Systems," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "We are pleased to be able to complement our market-leading TAXUS Stents with the addition of our PROMUS(TM) Everolimus Eluting Coronary Stent System in international markets, and the industry's deepest drug-eluting stent (DES) pipeline, which includes our third-generation TAXUS(R) Element(TM) Stent -- currently in clinical trials."
PROMUS is a private-labeled XIENCE(TM) V Everolimus Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific Corporation outside the United States. It is currently pending approval by the U.S. Food and Drug Administration and is not commercially available in the United States.
Schedule of Events Sunday, October 21 (all times are ET) -- TAXUS ARRIVE data. Two-year follow-up data and sub-group analysis from the TAXUS ARRIVE registry will be presented by John M. Lasala, M.D., PhD, at the DES Summit at 1:19 p.m. in Ballroom C of the Washington Convention Center. The ARRIVE program is designed to collect and analyze "real-world" safety and clinical outcomes data from the TAXUS Express2 Paclitaxel-Eluting Stent System in the treatment of patients with coronary artery disease. The Company plans to issue a press release at this time. Monday, October 22 -- Spirit III Clinical Trial Results -- XIENCE V (PROMUS) Stent and TAXUS Stent. At 12:15 p.m., one-year data from Abbott's Spirit III Clinical Trial will be presented by Gregg W. Stone, M.D., at a late-breaking trial session in the main arena. Dr. Stone will provide an updated analysis of 1,002 patients treated with the XIENCE V (PROMUS) Stent or the TAXUS Express Stent. SPIRIT III is a large-scale, randomized, non-inferiority, U.S. pivotal trial. The Company plans to issue a press release at this time. -- TAXUS ATLAS Small Vessels and Long Lesions studies. Nine-month data from the TAXUS ATLAS global, multi-center studies will be presented at a late-breaking trial session by the study's co-principal investigator Mark A. Turco, M.D., at 1:00 p.m. in the main arena. Dr. Turco will present clinical and angiographic follow-up data on patients treated with the TAXUS Liberte 2.25 mm stent in small vessels (from the TAXUS ATLAS Small Vessel study) and the TAXUS Liberte 38 mm stent in long lesions (from the TAXUS ATLAS Long Lesion study). The Company plans to issue a press release at this time. -- TAXUS V de novo results. The Company will release three-year results from the TAXUS V de novo (DN) clinical trial, evaluating the long-term safety and clinical efficacy of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System versus bare-metal stents in complex patient populations, including small vessel lesions, long lesions, diabetics and multiple stents. The TAXUS V DN trial is a prospective, randomized, double-blind trial that has enrolled 1,172 patients at 66 sites in the U.S. The results will be presented by Stephen G. Ellis, M.D., at an oral abstract session at 3:45 p.m. in Room 147AB. -- TAXUS IV five-year results. The Company will release final five-year data from the TAXUS IV clinical trial, which evaluates the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System versus bare-metal stents. This prospective, randomized, double-blind study has enrolled 1,314 patients at 73 U.S. sites. The results will be presented by Dr. Ellis at 4:00 p.m. at an oral abstract session in Room 147AB. The Company plans to issue a press release at this time. Tuesday, October 23 -- CABERNET & BEACH Trial Results on Carotid Stenting. At 4:00 p.m., three-year follow-up results from the CABERNET and BEACH clinical trials will be presented in an oral abstract session by L. Nelson Hopkins, M.D., in Room 147AB. The CABERNET trial was designed to evaluate the safety and efficacy of the Company's NexStent(R) Carotid Stent System and FilterWire EZ(TM) Embolic Protection System, which received FDA approval in 2006. BEACH is a prospective, single-arm, multi-center trial designed to evaluate similar clinical outcomes of the Company's Monorail(R) Carotid WALLSTENT(R) Endoprosthesis in conjunction with the FilterWire EX(R) and FilterWire EZ(TM) Embolic Protection Systems in the treatment of high surgical-risk patients with carotid artery disease. The Company plans to issue a press release at this time. -- Analyst Meeting. At 5:30 p.m., the Company will host an analyst meeting in the Grand Ballroom of the Renaissance Hotel. The meeting is open to the media and will include a DES clinical program update by Dr. Donald Baim and a DES business update by Paul LaViolette. This meeting is being webcast and can be accessed in the Investor Relations section of Boston Scientific's website, www.bostonscientific.com. Please visit the website for details on how to register for the webcast or to access a replay, which will be archived for 90 days. -- Symposium on Drug-Eluting Stents. From 8:00 - 10:00 p.m., the Company will host a symposium entitled "Preclinical to Patients: The DES Pathway" chaired by Keith D. Dawkins, M.D., in the Grand Ballroom of the Renaissance Hotel. The symposium will include presentations on drug development and actions of current DES molecules by Aloke V. Finn, M.D.; the state of the DES market by Dr. Dawkins; late-breaking data on next-generation DES by Dr. Turco; and impact of dual anti-platelet therapy on DES outcomes by Steven R. Steinhubl, M.D. A reception will be held prior to the symposium at 7:00 p.m.
The Company will also release additional safety and efficacy data from its comprehensive DES clinical trial program, which will be presented at TCT as e- posters. Details can be found on the official TCT program.
Boston Scientific will present its latest innovations and live case broadcasts at booth 3021 in the Exhibition Hall. Key product demonstrations will include drug-eluting stents, carotid artery stenting and peripheral interventions. In addition, Boston Scientific will introduce enhancements to the iLab(R) Ultrasound Imaging System that give physicians the ability to preview device sizing decisions, colorize plaque and blood flow, and overlay color to enrich viewing the IVUS image.
TAXUS Liberte is an investigational device and not available for sale in the United States. TAXUS Element is currently in clinical trials and is not available for sale. The Carotid WALLSTENT is an investigational device in the United States and is limited by U.S. law to investigational use. The safety and effectiveness of the FilterWire EZ Embolic Protection System for use in carotid arteries has not been established in the U.S. and is currently investigational. XIENCE is a trademark of the Abbott Laboratories group of companies.
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 .
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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
CONTACT: Media Relations, Paul Donovan, +1-508-650-8541 (office) or+1-508-667-5165 (mobile), or Investor Relations, Dan Brennan,+1-508-650-8538 (office) or +1-617-459-2703 (mobile), both of BostonScientific Corporation
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Posted: October 2007