Medtronic CoreValve Evolut R System - Aortic transcatheter heart valve bioprosthesis, stent-like framework

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Medtronic Australasia Pty Ltd

Classe:

Class III

Fabricado por:

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

Área terapêutica:

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

Indicações terapêuticas:

The Medtronic CoreValve? Evolut? R system is a recapturable transcatheter aortic valve implantation system, which includes the CoreValve? Evolut? R transcatheter aortic valve, the EnVeo? R delivery catheter system, and the EnVeo? R loading system. The support frame is manufactured from Nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration. The CoreValve Evolut R system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.; The CoreValve Evolut R system is also indicated for patients with a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are at high or greater risk for surgical aortic valve replacement (AVR) where high risk is defined as Society of Thoracic Surgeons operative risk score ?8% or documented heart team agreement of risk for AVR due to frailty or comorbidities.

Status de autorização:

A

Data de autorização:

2016-12-23