BioStable - Model HAART 200 - Aortic Annuloplasty Device for Bicuspid Aortic Valves
The HAART 200 Device was designed to support symmetric repair of bicuspid aortic valve. Reduce & prevent annular dilatation. Remodel the valve into a circular, 180° configuration. Establish effective coaptation geometry and simplify leaflet repairs.
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Details
Symmetric repair of bicuspid aortic valves has been shown to be the most durable reconstruction.[1] The HAART 200 devices are designed to create a symmetric repair with the commissures positioned at 180°. The bicuspid annuloplasty devices are sized to maximize the non-fused cusp to comprise half of the valve. The other half of the valve is constructed from the two fused cusps.
The HAART 200 Aortic Annuloplasty Devices help establish effective coaptation geometry and simplify the leaflet repair procedures by:
- reducing annular dilatation and drawing the leaflets toward the midline and
- remodeling the valve into a circular, 180° configuration.[2]
The subcommisural posts of the HAART 200 devices flare outward to mirror normal anatomic geometry and support a wide valve opening with low gradients.
Standardized Annuloplasty Technique
As with the HAART 300 Aortic Annuloplasty Device, the sizing and implantation techniques for the HAART 200 Aortic Annuloplasty Device have been standardized to make bicuspid valve repair simpler and more repeatable. Device size is chosen based on measurement of the non-fused leaflet anatomy and implantation of the device is accomplished with nine sutures to position the device and secure it to the valve annulus.
HAART 200 Aortic Annuloplasty Device Study
Results from the 16 patient, multicenter, HAART 200 Aortic Annuloplasty Device study are encouraging. Significant improvements in in aortic insufficiency and NYHA class have been observed.
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