FDA Grants Clearance to BioStable Science & Engineering’s Aortic Annuloplasty Device
BioStable Science & Engineering has received FDA market clearance for its HAART 300 aortic annuloplasty device.
The device is designed to re-size, reshape and stabilize the aortic annulus to restore valve competence and help prevent recurrent aortic regurgitation.
The device received CE Mark approval in 2016. — Cynthia Jessup