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

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Mevcut itibaren:

Abbott Medical Australia Pty Ltd

Sınıf:

Class III

Tarafından üretildi:

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

Terapötik alanı:

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

Terapötik endikasyonlar:

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).

Yetkilendirme durumu:

A

Yetkilendirme tarihi:

2022-11-23