BioStable Science & Engineering, Inc. announced today it has received FDA market clearance for the HAART 200 Aortic Annuloplasty Device, the first and only annuloplasty device designed specifically for bicuspid aortic valve repair.
BioStable Science & Engineering Announces announced today the first commercial uses of the HAART 300 Aortic Annuloplasty Device in the U.S. by doctors at the West Virginia University (WVU) Heart and Vascular Institute in Morgantown, West Virginia. Dr. Lawrence Wei, Dr. Vinay Badhwar and Dr. J. Scott Rankin, were the collaborating surgeons for the procedures.
BioStable Science & Engineering, Inc. announced today it has received FDA market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal annuloplasty device designed for aortic valve repair.
BioStable Science & Engineering, Inc. announced today that it has completed a direct de novo application to the U.S. Food and Drug Administration (FDA) for Class II designation of the HAART 300 Aortic Annuloplasty Device.
BioStable Science & Engineering, Inc. announced today that the first commercial implantation of its HAART 300 Aortic Annuloplasty Device was performed by Dr. Domenico Mazzitelli on Wednesday May 11th at the German Heart Center Munich.