CoreValve, S.A. Completes Enrollment Of Its 'Second-Generation 21-French' ReValving(TM) System International Clinical Trial For Non-Surgical Replacement Of The Diseased Aortic Heart Valve Of Patients Not Eligible For Open-Heart Surgery
IRVINE, Calif. & PARIS--(BUSINESS WIRE)--June 28, 2006--CoreValve (www.corevalve.com) announced today that it has completed minimal enrollment in a clinical trial involving its second-generation CoreValve Percutaneous ReValving(TM) System. Fifty-one patients at seven investigative sites in Europe and North America have now successfully undergone percutaneous aortic valve replacement (PAVR) with the 'second-generation, 21-French' ReValving(TM) system to treat either aortic stenosis, aortic regurgitation, or failed-tissue-valve-prosthesis conditions. Each of these patients was at very high risk for open-heart surgery. CoreValve expects to use the results of this trial as part of a future CE Mark submission seeking approval to market the ReValving system in the European Union.