Aortic transcatheter heart valve bioprosthesis, stent-like framework

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Disponibbli minn:

Medtronic Australasia Pty Ltd

Klassi:

Class I

Manifatturat minn:

Medtronic Corevalve LLC 1851 E Deere Avenue, Santa Ana, California, 92705 United States Of America

Żona terapewtika:

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

Indikazzjonijiet terapewtiċi:

The Medtronic Evolut PRO+ system is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., STS predicted risk of operative mortality score ?8% or at a ?15% risk of mortality at 30 days).

L-istatus ta 'awtorizzazzjoni:

A

Data ta 'l-awtorizzazzjoni:

2019-10-31