BioStable Science & Engineering Announces CE Mark Approval for the HAART 300 Aortic Annuloplasty Device

AUSTIN, Texas., 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. The company expects to begin a limited commercial launch of the product in select European heart centers in the second quarter of 2016.

“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,” commented Dr. J. Scott Rankin, inventor of the HAART Aortic Repair Technologies and Chief Medical Officer for BioStable Science & Engineering. “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.”

The HAART 300 Aortic Annuloplasty Device design is based on extensive anatomical studies and replicates the complex three-dimensional anatomy of the aortic valve.¹ The device is designed to resize, reshape, and stabilize the aortic annulus to restore valve competence and help prevent recurrent aortic regurgitation. In December 2015, BioStable completed the 2-year follow-up of its 65 patient, multicenter study of the HAART 300 Aortic Annuloplasty Device. Clinical results through the 1-year assessment were published in the March 2016 print edition of the European Journal of Cardio-Thoracic Surgery.² Patients undergoing aortic valve repair using the HAART 300 Aortic Annuloplasty Device experienced significant improvements in aortic insufficiency grade and New York Hospital Association (NYHA) score. Additionally, freedom from valve reoperation was 89%, and survival was greater than 95% when considering all-cause mortality. There was no valve-related mortality.

Joe Cunningham, M.D., BioStable board member and Managing Director of lead investor, Santé Ventures, added, “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 expects to submit an application for U.S. regulatory approval for the HAART 300 device in 2016 and is currently conducting a multicenter investigation of its HAART 200 Aortic Annuloplasty Device for use during bicuspid aortic valve reconstruction (NCT02071849).

John Wheeler, President and CEO, concluded by saying, “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.”

Source: BioStable Science & Engineering, Inc