Aortic valve bioprosthesis SAPIEN XT

bovine tissuesutureless

Product overview Edwards SAPIEN XT transcatheter heart valve is approved for delivery with the NovaFlex+ system and Ascendra+ system in 23 mm, 26 mm and 29 mm valve sizes. Balloon-expandable valve design for predictable deployment Low profile 16F access* *For the 23 mm Edwards SAPIEN XT valve via the transfemoral procedure. Approved for valve-in-valve procedures In failed surgical aortic bioprostheses for patients at high or greater surgical risk Edwards SAPIEN XT valve features Product animation Transfemoral procedural animation Edwards SAPIEN XT Transapical Procedural Animation Transaortic procedural animation Valve-in-valve procedural anim Approved for valve-in-valve procedures The Edwards SAPIEN XT valve expands treatment options for Heart Teams and patients by providing transcatheter valve-in-valve solutions in failed surgical bioprosthetic aortic valves (includes stenosis, insufficiency, or both). This allows patients at high or greater surgical risk to avoid an additional open heart procedure. Edwards SAPIEN XT transcatheter heart valve with the NOVAFLEX+ delivery system Indications: The Edwards SAPIEN XT transcatheter heart valve is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical 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., Society of Thoracic Surgeons operative risk score ≥ 8% or at a ≥ 15% risk of mortality at 30 days).