OLYMPIA Registry to Become Largest Drug- eluting Stent Registry
Jun 21, 2005 - 10:39:38 AM
Angiotech Pharmaceuticals, Inc. corporate partner Boston Scientific Corporation ("BSC") today announced that it has completed enrollment in the transitional phase of the world's largest drug-eluting stent registry. The OLYMPIA registry plans to enroll more than 30,000 patients at more than 600 centers in the United States, Europe and other international locations.
The registry is designed to collect and analyze "real-world" clinical outcomes data for BSC's next- generation TAXUS(R) Liberte(TM) paclitaxel-eluting stent system in the treatment of patients with coronary artery disease in markets where the product is commercially available.
The TAXUS Liberte coronary stent system will be the next generation to BSC's market-leading paclitaxel-eluting coronary stent system, TAXUS(R) Express2(TM). The Liberte stent features the Veriflex(TM) stent design, a highly flexible cell geometry with thin struts and uniform cell distribution.
This new platform has been designed to offer improved deliverability and conformability in challenging anatomy. It also features the enhanced TrakTip(TM) catheter tip, mounted on the Maverick2(TM) delivery catheter, designed to provide better lesion crossability. In addition, TrakTip has a low lesion-entry profile, also intended to further improve crossability.
The registry will enroll patients in five phases, corresponding to the commercial introduction of the TAXUS Liberte system in different regions of the world. The first, or transitional, phase involved the enrollment of 500 patients from a limited number of international markets in which BSC launched the TAXUS Liberte system in January 2005.
This initial phase, for which enrollment was just completed, will be followed by enrollment of approximately 30,000 patients from a broader number of international markets and European markets beginning this summer. The final U.S. phases are expected to start enrollment in 2006.
"We are very pleased that the OLYMPIA registry has reached this important enrollment milestone and is on track to become the world's largest drug- eluting stent registry," said Paul LaViolette, Chief Operating Officer of BSC. "OLYMPIA will provide valuable data about the real-world performance of our TAXUS Liberte coronary stent system, the first next-generation drug-eluting stent system."
BSC received the CE Mark for the bare-metal Liberte stent system in December 2003 and plans to launch the TAXUS (drug-eluting) Liberte system in Europe this year. In April 2004, BSC received U.S. Food and Drug Administration (FDA) approval for its Liberte(TM) bare-metal coronary stent system. BSC 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.
The OLYMPIA registry was formerly known as the OLYMPIC registry.
BSC acquired worldwide exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products and has co-exclusive rights to other vascular and non-vascular products.
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