Edwards Lifesciences SAPIEN 3 Instrucciones De Uso

Edwards SAPIEN 3 System
Edwards SAPIEN 3 Transcatheter Heart Valve
Edwards Commander Delivery System
Transfemoral, Subclavian / Axillary
Sistema Edwards SAPIEN 3
Válvula cardiaca transcatéter Edwards SAPIEN 3
Sistema de colocación Edwards Commander
Transfemoral, Subclavia/Axilar
Sistema Edwards SAPIEN 3
Válvula cardíaca transcateter Edwards SAPIEN 3
Sistema de administração Edwards Commander
Transfemoral, Subclávia/Axilar
Directory Directorio
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English (EN) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Español (ES) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Português (PT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Figures / Figuras / Figuras. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26–28
Symbol Legend / Significado de los símbolos /
Legenda de símbolos. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30–31
English
Instructions for Use
Implantation of transcatheter heart valves should be performed only by
physicians who have received Edwards Lifesciences training. The implanting
physician should be experienced in standard catheterization techniques. It is
at the physician's discretion to choose the appropriate access route to
implant the THV based on the patient anatomy and associated risks.
1.0 Device Description
Edwards SAPIEN 3 System
The Edwards SAPIEN 3 system consists of the Edwards SAPIEN 3 transcatheter
heart valve and delivery systems.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards,
Edwards Commander, Edwards SAPIEN, Edwards SAPIEN 3, eSheath,
INSPIRIS RESILIA, Qualcrimp, SAPIEN, SAPIEN 3, ThermaFix, and VFit are
trademarks of Edwards Lifesciences Corporation. All other trademarks are
the property of their respective owners.
Diretório
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• Edwards SAPIEN 3 Transcatheter Heart Valve (Figure 1)
The Edwards SAPIEN 3 transcatheter heart valve (THV) is comprised of a
balloon-expandable, radiopaque, cobalt-chromium frame, trileaflet bovine
pericardial tissue valve, and polyethylene terephthalate (PET) inner and
outer fabric skirts. The leaflets are treated according to the
Carpentier-Edwards ThermaFix process.
The THV is intended to be implanted in a native annulus size range associated
with the three-dimensional area of the aortic annulus measured at the basal
ring during systole:
Native Valve Annulus Size (CT)
Native Valve
Annulus Size
(TEE)* Area
16-19 mm 273 - 345 mm2
18-22 mm 338 - 430 mm2
21-25 mm 430 - 546 mm2
24-28 mm 540 - 683 mm2
THV size recommendations are based on native valve annulus size, as
measured by transesophageal echocardiography (TEE) or computed
tomography (CT). Patient anatomical factors and multiple imaging
modalities should be considered during THV size selection.
Note: Risks associated with undersizing and oversizing should be
considered to minimize the risk of paravalvular leak, migration,
and/or annular rupture.
*Due to limitations in two-dimensional images, 2-D TEE imaging should be
supplemented with 3-D area measurements.
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Table 1
Area Derived
Diameter THV Size
18.6 - 21.0 mm 20 mm
20.7 - 23.4 mm 23 mm
23.4 - 26.4 mm 26 mm
26.2 - 29.5 mm 29 mm