BioStable Science & Engineering wins CE Mark for annuloplasty device

Cardiovascular device company BioStable Science & Engineering said today it won CE Mark approval in the European Union for its HAART 300 aortic annuloplasty device designed for aortic valve repair. The Austin, Texas-based company said its HAART 300 is an internal aortic annuloplasty ring designed to replicate the anatomy of the aortic valve and resize, reshape and stabilize the aortic annulus to restoe valve competence and prevent recurrent aortic regurgitation. “In patients with mitral and tricuspid valve disease, valve repair has become the standard of care due to superior outcomes compared to biological or mechanical valve replacement. Annuloplasty rings are the foundation of most successful valve reconstructions, and the HAART 300 Aortic Annuloplasty Device is the first internal geometric annuloplasty ring to be developed for the aortic valve. Availability of an effective annuloplasty device could expand the benefits of valve repair to the majority of patients with aortic valve insufficiency,” chief medical officer Dr. J. Rankin said in prepared remarks. Data from a study of the HAART 300 indicated that patients who underwent aortic valve repair using the company’s device showed significant improvements in aortic insufficiency grade and NYHA scores, with a reported 89% freedom from valve reoperation and a 95% rate of freedom from all-cause mortality. “With completion of the HAART 300 studies and CE Mark approval, the BioStable team has made sig...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Cardiovascular Regulatory/Clearance BioStable Science & Engineering Source Type: news