The HighLife transcatheter mitral valve implantation system.

Device description Name and manufacture: HighLife SAS, Paris, France. Approval status: Preclinical. Platform: Nitinol. Specific design: The HighLife transcatheter mitral valve replacement device is a two-component system (Figure 1). The valve prosthesis is implanted over a delivery system in the mitral position and is anchored by interacting and then reaching an equilibrium position with a previously positioned subannular implant (SAI). The valve prosthesis shape has a preformed groove in the annular region so as to create an interference with the loosely placed SAI. The SAI is placed around the prosthesis groove, which blocks it from slipping into the atrium, whereas the inflow shape of the stent itself blocks it from slipping in the opposite direction into the ventricle. The combined dynamic of these two opposite interactions results in a stable position in the heart (which could be described as an equilibrium position that adapts to different anatomies). The HighLife transcatheter mitral valve (TMV) is a stented mitral bioprosthesis made from glutaraldehyde cross-linked bovine pericardium mounted on a laser-cut nitinol frame. The SAI is intended to create a closed loop with a fixed perimeter around the patient’s native valve leaflets and chordae. In its final position, it allows the TMV to remain in a stable position in the heart, the native leaflets being positioned between the SAI and TMV. Delivery approach: Transatrial and transapical. Device sizes/length: Not specified.