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

Intended purpose

To: The Medtronic 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 Medtronic Evolut FX system is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical or transcatheter 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., predicted risk of surgical mortality ≥8% at 30 days, based on the STS risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Functional description

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.