BioStable Science & Engineering out of Austin, Texas won FDA clearance for its HAART 200 aortic annuloplasty device indicated for repair of congenital bicuspid aortic valve in patients with aortic valve insufficiency. A similar device, the HAART 300 for people with all three aortic valve leaflets, was cleared by the FDA earlier this year.
The HAART devices reshape and therefore repair the valve, avoiding replacing the native valve with a more complicated device. They effectively make the annular diameter smaller and more circular, helping the leaflets open and close more efficiently and securely. Because the devices keep the shape of the annular opening, they should help patients avoid more complicated procedures in the long term.