Device Dossier

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

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

Intended purpose

The Navitor™ Transcatheter Aortic Valve 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 three radiopaque markers (Vision Technology) to aid with valve visibility. The NaviSeal™ cuff provides the sealing area for implantation and provides paravalvular leak reduction by filling any potential voids between the native valve and the stent.

TGA Public Summary