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

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Medtronic Australasia Pty Ltd

Klass:

Class III

Tillverkad av:

Medtronic Inc 710 Medtronic Parkway, Minneapolis, Minnesota, 55432 United States Of America

Terapiområde:

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

Terapeutiska indikationer:

The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. It includes 3 gold radiopaque markers and are manufactured by suturing valve leaflets and an inner skirt from porcine pericardium into a tri-leaflet configuration. The bioprosthesis has a porcine pericardial tissue outer skirt (wrap), which is 1.5 cells in height and is sutured to the inflow section of the bioprosthesis. The Evolut FX 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 Evolut FX 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.