www.fdanews.com/articles/67084-corevalve-to-commence-revalving-system-clinical-trial
COREVALVE TO COMMENCE REVALVING SYSTEM CLINICAL TRIAL
January 3, 2005
CoreValve has received approval from the German government - Bezirksregierung Koln, state of Nordrhein-Westfalen, Cologne -- to immediately commence a clinical trial of its proprietary ReValving System to nonsurgically replace diseased aortic heart valves in 10 patients who are contraindicated for open-heart surgery. Previously, CoreValve received "local" IRB approval from The Heart Center, Seigburg, Germany, where the clinical trial will take place.
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