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

Intended purpose

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 system consists of a recapturable transcatheter aortic valve replacement system, which includes the Evolut FX+ TAV (bioprosthesis), the delivery catheter system, and the loading system. The bioprosthesis is manufactured by suturing 3 valve leaflets and an inner skirt, made from a single layer of porcine pericardium, onto a self-expanding, multi-level, radiopaque frame. The support frame has expanded windows behind each of the 3 valve leaflets for post implant access to the coronary ostia.