BioStable - Model HAART 300 - Aortic Annuloplasty Device
The HAART 300 Aortic Annuloplasty Device was designed from mathematical reconstructions of high resolution, computed tomographic angiogram (CTA) images of normal aortic valves.[1] The HAART 300 Aortic Annuloplasty Device replicates the normal annular anatomy, having an elliptical base with a 2:3 minor-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.
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Standardized Annuloplasty Technique
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.
HAART 300 Clinical Trial
The multi-center, 65 patient, HAART 300 clinical trial provides strong evidence of the potential safety and efficacy of the HAART 300 device.[3]
- Low morbidity, no in-hospital mortality
- 95% survival at mean 2 year follow-up
- Mean gradient of 9.4 mm Hg and valve areas of 2.7 cm2
- Significant improvement in AI grade and NYHA class
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