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.
BioStable Science & Engineering, Inc. announced today the company has received CE Mark approval for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal aortic annuloplasty ring for aortic valve repair.