Aortic valve bioprosthesis SAPIEN 3
bovine tissuesutureless

aortic valve bioprosthesis
aortic valve bioprosthesis
aortic valve bioprosthesis
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Characteristics

Valve type
aortic
Material
bovine tissue
Features
sutureless

Description

SAPIEN 3 Ultra valve: The valve you know and trust continues to evolve Built upon the proven SAPIEN platform, the SAPIEN 3 Ultra transcatheter heart valve is designed with your patient's future needs in mind. Sealing skirt technology Now featuring a ~40% taller*, textured polyethylene terephthalate (PET) outer skirt. Important safety information Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System Indications: The Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are 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 Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral 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). Contraindications: The valves and delivery systems are contraindicated in patients who cannot tolerate an anticoagulation/antiplatelet regimen or who have active bacterial endocarditis or other active infections.

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.