Tendyne Mitral Valve - Mitral transcatheter heart valve bioprosthesis

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Saadav alates:

Abbott Medical Australia Pty Ltd

Klass:

Class III

Valmistatud:

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

Terapeutiline ala:

60246 - Mitral transcatheter heart valve bioprosthesis

Näidustused:

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).

Volitamisolek:

A

Loa andmise kuupäev:

2022-11-23