Interventional device developer Boston Scientific of Natick, MA, has received an investigational device exemption from the Food and Drug Administration to begin its ATLAS clinical trial using its Liberte coronary stent as a platform for the firm's paclitaxel-eluting coronary stent system.
Taxus Liberte will be the next generation to Boston Scientific's current paclitaxel-eluting stent system, Taxus Express2, the company said. The Liberte stent is currently available in international markets in a bare-metal version, according to the developer.
The ATLAS trial is designed to assess the safety and efficacy of a slow-release dose formulation paclitaxel-eluting Taxus Liberte stent system for the treatment of coronary artery disease. The trial is scheduled to enroll 822 patients at 60 sites in the U.S., Canada, Australia, New Zealand, Singapore, Hong Kong, and Taiwan, Boston Scientific said.
By AuntMinnie.com staff writersJuly 22, 2004
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