Tendyne Mitral Valve - Mitral transcatheter heart valve bioprosthesis

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Abbott Medical Australia Pty Ltd

Klasse:

Class III

Produsert av:

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

Terapeutisk område:

60246 - Mitral transcatheter heart valve bioprosthesis

Indikasjoner:

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).

Autorisasjon status:

A

Autorisasjon dato:

2022-11-23