CoreValve Evolut PRO system - Aortic transcatheter heart valve bioprosthesis, stent-like framework

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

可用日期:

Medtronic Australasia Pty Ltd

类:

Class III

厂商:

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

治疗领域:

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

疗效迹象:

The Evolut PRO system is a recapturable transcatheter aortic valve replacement system, which includes the CoreValve Evolut PRO 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 an inner skirt from porcine pericardium into a tri-leaflet configuration. The CoreValve Evolut PRO 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 PRO 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.

授权状态:

A

授权日期:

2019-07-08