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# BioStable Aortic Annuloplasty Device Cleared
- URL: https://www.fdaweb.com/biostable-aortic-annuloplasty-device-cleared/
- Published: 2017-08-15T12:00:00.000Z
- Updated: 2026-09-14T22:41:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139389

FDA has cleared a BioStable Science & Engineering 510(k) for the HAART 200 Aortic Annuloplasty Device, an annuloplasty device designed specifically for bicuspid aortic valve repair. The device is designed to facilitate valve repair in patients with aortic valve insufficiency. It is intended to reduce annular diameter based upon leaflet size, to conform the annulus to a circular, symmetric shape for improved valve function, and to stabilize the annular geometry long-term, according to the company.

  
“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,” BioStable says. “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.”