Device Dossier

Navitor Titan™ Transcatheter Aortic Valve - Aortic transcatheter heart valve bioprosthesis, stent-like framework

Device Dossier for Navitor Titan™ Transcatheter Aortic Valve - Aortic transcatheter heart valve bioprosthesis, stent-like framework (Aortic transcatheter…

Intended purpose

The Navitor™ Transcatheter Implantation System is indicated for transcatheter aortic valve implantation through transfemoral access in patients with symptomatic severe native aortic stenosis.

Functional description

The Navitor Valve is a pericardial, tri-leaflet valve, mounted inside a self expanding stent. It contains 3 radiopaque markers (Vision Technology) to aid with visibility. The NaviSeal cuff provides paravalvular leak reduction by filling any potential voids between the native valve and the stent

TGA Public Summary