BioStable Science & Engineering, a company based in Austin, Texas, won FDA clearance for its HAART 300*Aortic Annuloplasty Device. Having received the CE Mark clearance last year, the company has already begun distributing the Device in a few specialty European centers. According to the firm, this is the first Annuloplasty Device for Repair of the Aortic valve that’s been made available to physicians.
Aortic regurgitation can occur when the Aortic annulus is poorly shaped, **t letting the valve’s leaflets come together properly. The HAART 300 Device is used to reshape and stabilize the Aortic annulus so that the natural valve leaflets close properly, preventing blood from flowing in reverse*through the aorta.
Its 3D shape is designed to match the native anatomy of the Aortic valve. Data from CT angiography scans of healthy Valves was used to create its shape, so that it resembles a healthy valve as much as possible.
From the product page:
The HAART 300 Aortic Annuloplasty Device replicates the **rmal annular anatomy, having an elliptical base with a 2:3 mi**r-to-major axis ratio and three outwardly flaring posts spaced equally around the base circumference. The Device is designed to reduce annular dilatation, restore three-dimensional annular geometry, and serve as a framework to guide leaflet Repair procedures
Device sizing is determined from measurements of leaflet free-edge length. Using leaflet anatomy to determine implant size helps ensure that HAART Annuloplasty Devices restore appropriate three-dimensional coaptation geometry for the available leaflet tissues. Implantation is accomplished through placement of nine annular sutures that position the Device under the annulus and away from the valve leaflets. Once implanted, the HAART Annuloplasty Device serves as a framework to guide leaflet Repair techniques to re-establish valve competence.
03-26-2017, 02:08 AM
HAART 300 Aortic Annuloplasty Device Cleared by FDA to Repair Aortic Valves
Aortic regurgitation can occur when the Aortic annulus is poorly shaped, **t letting the valve’s leaflets come together properly. The HAART 300 Device is used to reshape and stabilize the Aortic annulus so that the natural valve leaflets close properly, preventing blood from flowing in reverse*through the aorta.
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