Internal Annuloplasty for Bicuspid Aortic Valve

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

Symmetric, 180° Valve Reconstruction

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.


HAART 200 Device for Bicuspid Aortic Valves

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.

HAART 200 Aortic Annuloplasty Device - topview
HAART 200 Aortic Annuloplasty Device - sideview


Simple & Standardized Annuloplasty Technique

Sizing – Innovative & Accurate

Determined from leaflet free-edge length for improve leaflet coaptation

Device Placement

Post & Looping sutures to ensure stable device to annulus fixation

Accurate Leaflet Based Sizing

Leaflet free-edge measurements determine the normal annular dimension for improved leaflet coaptation

No Deep Root Dissection

Save time and avoid the deep root dissection and coronary reimplantation when not indicated

Standardized Leaflet Repairs

Devices recruit the leaflets towards the midline and provide a stable base for reproducible leaflet reconstruction

See how the HAART Devices are simplifying repair & their broad range of applications

 


Glowing Clinical Evidence

HAART 200 Clinical 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.[2]

HAART 200 Aortic Insufficiency Grade NYHA Class

AATS 2021 Presentation

Results from the 70 patients with max follow-up of 42 months presented at AATS 2021. [3]

  • BAV Types – 64 Sievers Type 1 valves, 3 Type 0 and 3 Type 2
  • Leaflet reconstruction utilized Schäfers’ central leaflet plication & cleft closure approach with HAART 200 Annuloplasty Device
  • AI grade fell from 2.4±1.5 to 0.2±0.8
  • Mean Gradient: 12.3±5.8 mmHg

45
Peer Reviewed Publications

153
Trained Surgeons

99
Trained Centers

  1. Schneider U, Hofmann C, Schöpe J, et al. Long-term Results of Differentiated Anatomic Reconstruction of Bicuspid Aortic Valves. JAMA Cardiol. 2020;5(12):1366–1373. doi:10.1001/jamacardio.2020.3749
  2. Mazzitelli D, at al. A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty. Ann Thorac Surg 2015;99:2010–6.
  3. Gerdisch M. et al. Early Results of Geometric Ring Annuloplasty for Bicuspid Aortic Valve Repair During Aortic Aneurysm Surgery: A Multi-Institutional Analysis. AATS 2021, Presented May 1, 2021.