CoreValve, S.A. Announces That Its 18-French ReValving(TM) Phase III International Clinical Trial Is Now One-Third Enrolled Since Commencing Less Than Three Months Ago
IRVINE, Calif.--(BUSINESS WIRE)--CoreValve (www.corevalve.com) announced today that it has successfully completed one-third of the enrollment related to a phase III international clinical trial using its patented ReValving System. The Company’s system, consisting of a breakthrough 18-French-sized delivery catheter, has now been used successfully to percutaneously implant its proprietary porcine pericardial-tissue bioprosthesis over the diseased aortic heart valves of more than 30 patients in a “cath” lab setting. The safety-and-efficacy clinical trial is expected to enroll 100 patients or more at 12 sites in Europe and Canada.