OLYMPIA Registry Supports Positive Safety Profile of TAXUS® Liberte™ Stent System
Study of First Next-Generation Drug-Eluting Stent System Expands Enrollment
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Next Two Phases to Include Up to 30,000 Patients Worldwide
NATICK, Mass. and WASHINGTON, Oct. 20 -- Boston Scientific Corporation
(NYSE: BSX - News) today announced 30-day safety data from the transitional phase
of its OLYMPIA registry. The OLYMPIA registry is designed to collect and analyze "real-world" clinical
outcomes data using Boston Scientific's next-generation TAXUS® Liberte™
paclitaxel-eluting stent system in the treatment of patients with coronary artery
disease. Enrollment has begun in the next two phases of the study, which will
include up to 30,000 patients at 500 sites in more than 70 countries where the
product is commercially available. The Company made the announcement at the annual
Transcatheter Cardiovascular Therapeutics symposium, in Washington, D.C.
The OLYMPIA registry 30-day results include clinical outcomes data from 529 patients at 16 sites collected during the transitional phase, which completed enrollment in June and includes a large concentration of diabetic patients (49 percent). The primary endpoint for this phase of the registry is the rate of TAXUS Liberte stent-related cardiac events at 30 days post implant procedure as assessed by a Clinical Events Committee.
The 30-day results support safety, as demonstrated by a low incidence of cardiac events. The early safety profile compares favorably to the Company's ATLAS clinical trial, which is designed to support U.S. Food and Drug Administration approval of TAXUS Liberte stent system.
"These initial safety findings are encouraging and support the positive safety profile of the TAXUS Liberte stent," said Waqar Ahmed, M.D, M.S., F.A.C.C., of King Fahed Armed Forces Hospital in Jeddah, Saudi Arabia who was the first to enroll a patient in the OLYMPIA registry. "TAXUS Liberte is proving to offer greater deliverability along with the added confidence of proven safety and efficacy outcomes."
OLYMPIA enrollment expands up to 30,000 patients
The OLYMPIA registry is a global study comprised of five distinct phases. The second phase, known as the Inter-Continental Launch phase, began enrollment on September 13 when Dr. Carlos Calderas, in collaboration with Dr. Carlos Ascanio, enrolled the first patient at the Urologico San Roman in Caracas, Venezuela. Following CE Mark approval of TAXUS Liberte in September, Dr. K.E. Hauptmann of Barmherzige Brueder Hospital in Trier, Germany enrolled the first patient in the European Launch phase of the registry on October 10. Other physicians have begun enrollment in both phases. The final two U.S. phases are expected to begin patient enrollment in late 2006 once the TAXUS Liberte paclitaxel-eluting stent system is commercialized in the U.S., making OLYMPIA the world's largest drug-eluting stent registry.
"Continuing the next phase of OLYMPIA provides physicians with a great opportunity to further evaluate the performance of the TAXUS Liberte stent system in our daily practice," said OLYMPIA's Co-Principal Investigator, Martyn Thomas, M.D., F.R.C.P., Clinical Director of Cardiac Services at King's College Hospital in London and President of the British Cardiovascular Intervention Society. "We are hopeful that this new stent design will provide enhanced deliverability that will allow us to expand the utilization of this therapy to a broader patient base."
"The OLYMPIA registry seeks to study and provide answers to the challenging cases clinicians see every day," said Hank Kucheman, President of Boston Scientific's Interventional Cardiology business. "No two patients are alike and many present with complexities such as small vessels, long lesions and diabetes, which can be difficult to treat. This data will provide physicians with the information they need -- based on real cases -- to make the best treatment decisions for their patients."
The TAXUS Liberte coronary stent system is the next generation to Boston Scientific's market-leading paclitaxel-eluting coronary stent system, TAXUS® Express2™. The Liberte stent features the Veriflex™ stent design, a highly flexible cell geometry with thin struts and uniform cell distribution. This new platform has been designed to offer improved deliverability, conformability and lesion crossability in challenging anatomy, compared to the Company's first-generation drug-eluting stent systems.
The Company received the CE Mark for the TAXUS Liberte paclitaxel-eluting system in Europe in September. In April 2005, the Company received U.S. Food and Drug Administration approval for its Liberte™ bare-metal coronary stent system. Boston Scientific has completed enrollment in its ATLAS clinical trial, a pivotal study designed to support FDA approval of the TAXUS Liberte stent system, and anticipates FDA approval next year.
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:
Milan Kofol
508-650-8569
Investor Relations
Boston Scientific Corporation
Paul Donovan
508-650-8541
Media Relations
Boston Scientific Corporation
Source: Boston Scientific Corporation
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