BioStable Science & Engineering wins FDA nod for Haart 200 aortic annuloplasty device

Cardiovascular device developer BioStable Science & Engineering said today it won FDA clearance for its Haart 200 aortic annuloplasty device, touting it as the 1st and only such device designed specifically for bicuspid aortic valve repairs. The Austin, Texas-based company’s Haart 200 aortic annuloplasty device is intended for valve repairs in patients with aortic valve insufficiency due to the congenital bicuspid aortic valve malformation in which the aortic valve forms with only 2 functional valve leaflets instead of 3. Bicuspid aortic valve malformations affect up to 2% of the population and carry a significant risk of cardiovascular complications, including higher risk of developing aneurysms or dissections of the aorta, with approximately 53% of patients requiring aortic valve replacements within 25 years of being diagnosed. “Surgical repair of the bicuspid aortic valve can be a complex 3 dimensional problem because of variability in the valve anatomy. 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,” Haart aortic reapir tech inventor D...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves BioStable Science & Engineering Source Type: news