BioStable Science & Engineering Receives FDA Clearance of the HAART 300 Aortic Annuloplasty Device

BioStable Science & Engineering Inc. has received U.S. Food and Drug Administration (FDA) market clearance for the HAART 300 Aortic Annuloplasty Device, the first commercially available internal annuloplasty device designed for aortic valve repair. BioStable expects the HAART 300 Aortic Annuloplasty Device to be available to select U.S. heart centers this summer.
 
BioStable has released the HAART 300 Aortic Annuloplasty Device to a limited number of European heart centers since receiving CE Mark approval in 2016. Dr. J. Scott Rankin, professor of surgery at West Virginia University Heart and Vascular Institute and inventor of the HAART Aortic Repair Technologies, said, “It has been rewarding to collaborate with my European colleagues during the conduct of our clinical studies and recently with their adoption of the HAART 300 device into their clinical practices. They have demonstrated how our technologies help to simplify and standardize aortic valve repair, and I am excited to have the opportunity to share all that we have learned in Europe with the U.S. surgical community.”
 
The HAART 300 Aortic Annuloplasty Device design is based on extensive anatomical studies and replicates the complex three-dimensional anatomy of the normal aortic valve. The device is designed to re-size, reshape, and stabilize the aortic annulus to restore valve competence and help prevent recurrent aortic regurgitation. Valve repair is the gold standard surgical treatment in mitral and tricuspid valve disease because of the proven patient benefits over valve replacement. Annuloplasty devices are well recognized as a critical component of successful heart valve repair, and the HAART 300 Aortic Annuloplasty Device is the first commercially available annuloplasty device designed for repair of the aortic valve.
 
“We are very grateful for the cooperation between the BioStable management team and FDA that allowed the company to obtain this market clearance earlier than anticipated, and we look forward to the HAART 300 Aortic Annuloplasty Device being available to U.S. surgeons and patients looking for an alternative to valve replacement for the treatment of aortic valve insufficiency,” added Joe Cunningham, BioStable board member and managing director of lead investor Santé Ventures.
 
“With the HAART 300 now available in both Europe and the U.S., BioStable can turn our focus to completing the submissions for European and U.S. approval of our HAART 200 Aortic Annuloplasty Device for bicuspid aortic valve repair. With the technical challenges and higher rates of recurrent insufficiency frequently observed with existing bicuspid aortic valve repair techniques, there is an especially pressing need for new annuloplasty technologies for bicuspid vale repair,” said John Wheeler, president and CEO of BioStable. “We believe the combination of the HAART 300 and HAART 200 Aortic Annuloplasty Devices positions BioStable to be the industry leader in aortic valve repair in the near future.”
 
BioStable Science & Engineering is a developer of proprietary valve repair technologies that provide an alternative to valve replacement for patients with aortic valve disease. The company’s HAART Aortic Repair Technologies are designed to simplify and standardize aortic valve repair, enabling surgeons to offer the recognized clinical benefits of valve repair to patients undergoing surgical correction of aortic insufficiency or aortic root aneurysm.
 
The HAART 200 Aortic Annuloplasty Device is investigational and not available for sale.