Device Dossier
ALLEGRA Transcatheter Heart Valve - Aortic transcatheter heart valve bioprosthesis, stent-like framework
Device Dossier for ALLEGRA Transcatheter Heart Valve - Aortic transcatheter heart valve bioprosthesis, stent-like framework (Aortic transcatheter heart…
Intended purpose
The ALLEGRA Transcatheter Heart Valve (THV) is intended to be implanted within degenerative calcified aortic valves or in failing surgical aortic valve bioprostheses in a minimal invasive transcatheter implantation technique.
Functional description
The supra-annular valve has a tri-leaflet design and is constructed with six individual bovine pericardium parts, three parts for the skirt and three leaflets sewn to the skirt in a semi-lunar fashion to form the valve occluder. The pericardial inner skirt creates a 12 mm sealing against the native aortic annulus and thereby mitigating the risk of paravalvular leakage.