Tendyne Mitral Valve - Mitral transcatheter heart valve bioprosthesis

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:

60246 - Mitral transcatheter heart valve bioprosthesis

Wskazania:

The Tendyne Mitral Valve is a bioprothesis designed for transapical implantation within the native mitral valve. The valve has three pericardial leaflets sewn onto a circular, self-expanding frame. The inner frame is sewn inside a self-expanding outer frame. The outer frame helps orient the prosthesis inside the native mitral valve. Indicated for the treatment of the native mitral valve without prior mitral valve intervention in patients with symptomatic (NYHA Class III or IV) severe mitral valve regurgitation, a life expectancy between 1 and 5 years, left ventricular ejection fraction (LVEF) ? 30%, left ventricular end-diastolic dimension (LVEDD) ? 7.0 cm, who do not have severe mitral annular calcification and are deemed not suitable for surgical repair or replacement or transcatheter mitral repair who have secondary MR and are symptomatic despite maximally-tolerated guideline directed medical therapy (including cardiac resynchronization therapy, if indicated).

Status autoryzacji:

A

Data autoryzacji:

2022-11-23