Edwards SAPIEN 3 Instrucciones De Uso

Edwards SAPIEN 3 Transcatheter Heart Valve System Edwards
SAPIEN 3 Transcatheter Heart Valve
Edwards COMMANDER Delivery System
Pulmonic Valve Implantation
Sistema de válvula cardiaca transcatéter Edwards SAPIEN 3
Válvula cardiaca transcatéter Edwards SAPIEN 3
Sistema de colocación Edwards COMMANDER
Implantación de la válvula pulmonar
Sistema de válvula cardíaca transcateter Edwards SAPIEN 3
Válvula cardíaca transcateter Edwards SAPIEN 3
Sistema de colocação Edwards COMMANDER
Implantação de válvula pulmonar
Directory ■ Directorio ■ Diretório
English (EN).....................................................................................................................1
Español (ES).................................................................................................................... 8
Português (PT)............................................................................................................ 15
Figures ■ Figuras ■ Figuras.....................................................................................22
Symbol Legend ■ Significado de los símbolos ■ Legenda de símbolos
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English
Instructions for Use
Implantation of the transcatheter heart valve should be performed only
by physicians who have received Edwards Lifesciences training. The
implanting physician should be experienced in standard catheterization
techniques.
1.0 Device Description
Edwards SAPIEN 3 Transcatheter Heart Valve System
The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) system consists of
the Edwards SAPIEN 3 transcatheter heart valve and delivery system.
• 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, a 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 following table identifies the sizing recommendations for the non-
compliant Right Ventricular Outflow Tract (RVOT) conduit and THV-in-
THV in the pulmonic position using balloon sizing:
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards,
Edwards COMMANDER, Edwards eSheath, Edwards SAPIEN,
Edwards SAPIEN 3, eSheath, INSPIRIS, INSPIRIS RESILIA, Qualcrimp,
RESILIA, SAPIEN, SAPIEN 3, ThermaFix, and VFit are trademarks of
Edwards Lifesciences Corporation. All other trademarks are the property
of their respective owners.
Landing Zone Diameter
16.5 – 20.0 mm
20.0 – 23.0 mm
23.0 – 26.0 mm
26.0 – 29.0 mm
Note: For a failing stentless bioprosthesis, consider sizing
recommendations for a non-compliant Right Ventricular Outflow
Tract (RVOT) conduit landing zone.
For THV-in-surgical valve procedures, size recommendations for
bioprosthesis True Inner Diameter (True ID) are shown in the table below:
Surgical Valve True Inner
[1]
Diameter (ID)
16.5 – 19.0 mm
18.5 – 22.0 mm
22.0 – 25.0 mm
25.0 – 28.5 mm
Note: Surgical valve 'True ID' may be smaller than the labeled valve
size. The dimensions of the failed bioprosthesis should be
determined so that the appropriate THV size can be implanted and is
best determined by using balloon sizing and/or computed
tomography.
Sizing recommendations for implanting the Edwards SAPIEN 3
transcatheter heart valves in a failing INSPIRIS RESILIA surgical
bioprosthesis in sizes 19 - 25 mm are provided in the table below:
INSPIRIS RESILIA Valve
(model 11500A)* Labeled Size
19 mm
1
Table 1
THV Size
20 mm
23 mm
26 mm
29 mm
Table 2
THV Size
20 mm
23 mm
26 mm
29 mm
Table 3
THV Size
20 mm or 23 mm