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Abbott DES trials

This article was originally published in The Gray Sheet

Executive Summary

Abbott will outline U.S. pivotal trial protocol for its ZoMaxx ABT-578-eluting stent at the Transcatheter Cardiovascular Therapeutics conference Sept. 27-Oct. 1 in Washington, D.C. FDA discussions are underway concerning an IDE application. On Sept. 14, the firm began enrollment in its 400-patient, randomized, non-inferiority ZOMAXX I trial to support a European CE mark. Abbott expects to launch the device in Europe in late 2006...



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