BioStable Science & Engineering has received US Food and Drug Administration (FDA) market clearance for the HAART 200 aortic annuloplasty device. This is the first and only annuloplasty device designed specifically for bicuspid aortic valve repair.
This adds to the FDA’s previous clearance of the HAART 300 device.
Patients with BAV have significantly higher risk of developing aneurysms or dissections of the aorta and approximately 53% of patients will require aortic valve replacement within 25 years of being diagnosed.1 Most BAV patients undergo aortic valve replacement between 40 and 60 years of age, subjecting them to increased risk of reoperation or complications associated with valve replacement technologies. Aortic valve repair is an emerging surgical alternative for patients with bicuspid aortic valve insufficiency. It may offer improved patient outcomes compared to valve replacement.
The HAART 200 aortic annuloplasty device is designed to facilitate valve repair in patients with aortic valve insufficiency due to BAV. The device is designed to reduce annular diameter based upon leaflet size, to conform the annulus to a circular, symmetric shape for improved valve function, and to stabilise the annular geometry long-term.
“Surgical repair of the bicuspid aortic valve can be a complex three dimensional problem because of variability in the valve anatomy,” explains J Scott Rankin, professor of Surgery at West Virginia University Heart and Vascular Institute, and inventor of the HAART aortic repair technologies. “Implantation of the HAART 200 Aortic Annuloplasty Device conforms the native valve to the three dimensional shape of the device, creating a circular valve geometry and aligning the leaflet commissures into the preferred 180 degree orientation. Conforming the native valve to this shape simplifies assessment and reconstruction of the valve leaflets and creates a central flow pattern of blood through the valve which may improve the long-term durability of the repair.”