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Edwards extends heart valve trial

This article was originally published in The Gray Sheet

Executive Summary

Firm will expand U.S. feasibility trial for its Cribier-Edwards percutaneous aortic heart valve by 35 patients before initiating a pivotal trial. Discussion with FDA about the pivotal trial design continues, but the study will not begin until all 55 patients in the current study complete six-month follow-up, according to the firm. Edwards expects a CE mark based on an ongoing European study by the end of 2007...

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