Data provided by company:
- The valve system is based on the Carpentier-Edwards PERIMOUNT platform and Edwards’ innovations in transcatheter heart valves.
- The EDWARDS INTUITY valve is a stented tri-leaflet bovine pericardial bioprosthesis with a balloon expandable, cloth-covered stent frame at the inflow aspect.
- The valve is positioned supra-annularly using three guiding sutures. The sutures are tied, and the aortotomy closed following frame expansion with a balloon catheter.
- Implantation through right-sided minimal thoracotomy, valve orientation identical to native valve
- At 3 months, the mean gradient was significantly lower for the EDWARDS INTUITY valve than for the conventional valves (8.5 3.4 vs 10.3 4.8 mm Hg, p ¼ 0.044) in Borger MA et al. A Randomized Multicenter Trial of Minimally Invasive Rapid Deployment Versus Conventional Full Sternotomy Aortic Valve Replacement. Ann Thorac Surg 2015 Jan;99(1):17-25
- However, no size-specific data on hemodynamic performance and no EOAi calculator is available.
- Copyright by Edwards Lifesciences
- Kocher AA. et al., One-year outcomes of the Surgical Treatment of Aortic Stenosis with a Next Generation Surgical Aortic Valve (Triton) trial: a prospective multicenter study of rapid-deployement aortic valve replacement with the Edwards Intuity Valve System, J Thorac Cardiovasc Surg. 2013 Jan;145(1):110-5