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

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Dostępny od:

Abbott Medical Australia Pty Ltd

Klasa:

Class III

Wyprodukowano przez:

Abbott Medical 177 County Road B East, St Paul, Minnesota, 55117 United States Of America

Dziedzina terapeutyczna:

60245 - Aortic transcatheter heart valve bioprosthesis, stent-like framework

Wskazania:

The Navitor? valve is a pericardial, tri-leaflet valve, mounted inside a self-expanding stent that is radiopaque. 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. The valve is designed to be implanted in the native calcific aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve. Indicated for transcatheter aortic valve implantation through transfemoral access in patients with symptomatic severe native aortic stenosis who are considered high or extreme risk for surgical aortic valve replacement (AVR).

Status autoryzacji:

A

Data autoryzacji:

2022-11-23