HAART 300 Aortic Annuloplasty Device2018-09-27T23:04:30+00:00

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]

Computed Tomographic Angiograms (CTA)
HAART 300 Aortic Annuloplasty Device topview
HAART 300 Aortic Annuloplasty Device - sideview

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

HAART 300 Sizer

Determined from leaflet free-edge length.

Post Sutures

HAART 300 Post Suture 1HAART 300 Post Suture 2

Prolene horizontal mattress sutures with pledgets above the annulus.

Looping Sutures

HAART 300 Looping Suture 1HAART 300 Looping Suture 2

Prolene horizontal mattress sutures with pledgets above the annulus.

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
HAART 300 Clinical Trial

  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.