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.[2]

HAART 300 Aortic Annuloplasty Device
HAART 300 Aortic Annuloplasty Device

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.

Sizing

BioStable sizing of leaflet using the sizer

Determined from leaflet free-edge length.

Post Sutures

BioStable placing the post sutures BioStable suturing technique for the HAART 300 posts

Prolene horizontal mattress sutures with pledgets above the annulus.

Looping Sutures

BioStable suturing technique below the valve leaflets BioStable leaflet section looping sutures

Two looping sutures around each ring segment.

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

  1. Rankin JS, et al. A refined hemispheric model of normal human aortic valve and root geometry. J Thorac Cardiovasc Surg. 2013 Jul;146(1):103-108.
  2. Crooke PS, et al. Design Characteristics of a Three-Dimensional Geometric Aortic Valve Annuloplasty Ring. Innovations 2013;8:364-370.
  3. Mazzitelli D, et al. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg 2016;49:987–93.