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 significant progress towards making aortic valve repair a more accessible treatment option for patients. Santé Ventures is excited about the opportunity for BioStable and its technologies,” BioStable board member Dr. Joe Cunningham said in a prepared statement.
BioStable said it expects to submit an application for FDA regulatory approval of the HAART device some time this year, and that the company is currently conducting a study of its HAART 200 aortic annuloplasty device designed for bicuspid aortic valve reconstruction.
“We are very pleased to announce the CE Mark approval of the HAART 300 Aortic Annuloplasty Device and want to thank our clinical investigators and their teams for their outstanding contributions to the HAART 300 studies. We look forward to the commercial release of the HAART 300 device and to executing our strategies to expand the availability of our HAART Aortic Repair Technologies,” CEO John Wheeler said in a press release.
BioStable said it is planning a limited commercial launch of the HAART 300 in select European heart centers during the 2nd quarter of this year.