Cardiovascular device developer BioStable Science & Engineering said yesterday it won FDA 510(k) clearance for its Haart 300 aortic annuloplasty device.
The Austin, Texas-based company touted the Haart 300 as the 1st commercially available internal annuloplasty device designed for aortic valve repair, expected to be available to select US heart centers this summer.
“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,” BioStable board member Joe Cunningham said in a prepared statement.
BioStable 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 restore valve competence and prevent recurrent aortic regurgitation. The device won CE Mark approval in the European Union in 2016.
BioStable Science & Engineering said that after implantation, its Haart 300 device “serves as a framework for completing the overall repair procedure to maintain the patient’s native valve.”
“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,” Haart aortic repair tech inventor Dr. J. Rankin of the West Virginia University Heart and Vascular Institute said in prepared remarks.
“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. 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,” prez & CEO John Wheeler said in a press release.