2
1.0 Device Description
•
Edwards SAPIEN XT Transcatheter Heart Valve
–
Model 9300TFX (Figure 1)
The Edwards SAPIEN XT Transcatheter Heart Valve is comprised of a balloon-expandable, radiopaque,
cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate (PET)
fabric skirt. The leaflets are treated according to the Carpentier-Edwards ThermaFix process.
Table 1
Valve Size
Height
23 mm
14.3 mm
26 mm
17.2 mm
29 mm
19.1 mm
Table 2
Native Valve Annulus Size
(TEE)
Native Valve Annulus Size
(CT)
Valve Size
Area
Area Derived Diameter
18-22 mm
314-415 mm
2
20-23 mm
23 mm
21-25 mm
415-530 mm
2
23-26 mm
26 mm
24-27 mm
530-660 mm
2
26-29 mm
29 mm
Valve 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 valve size selection. Note: Risks associated with undersizing and
oversizing should be considered.
For transcatheter valve-in-surgical valve procedures, size recommendations for surgical bioprostheses
with
internal orifice diameters
are shown in Table 3.
Table 3
Bioprosthesis Internal Orifice Diameter
SAPIEN XT Valve Size
18-21 mm
23 mm
21-23.5 mm
26 mm
23.5-27 mm
29 mm
NOTE: The internal orifice diameter of the surgical bioprosthesis must be determined so that the
appropriate valve size can be implanted. The bioprosthesis internal diameter of the primary
implanted device is best determined by using computed tomography, magnetic resonance
imaging, and/or transesophageal echocardiography to perform the necessary measurements. The
internal orifice diameter is a directly measured or area derived diameter measurement of the
internal opening of the failed surgical valve.
NOTE: Exact volume required to deploy the valve may vary depending on the bioprosthesis internal
orifice diameter. Do not exceed the rated burst pressure. See Table 4 for inflation parameters.
•
N Delivery System (Figures 2a, 2b, 2c)
The N delivery system (usable length 105 cm) is used for delivery of the Edwards SAPIEN XT
transcatheter heart valve. The delivery system includes a flex wheel for articulation of the flex catheter, a
tapered tip at the distal end of the delivery system to facilitate crossing the valve, and a balloon catheter
for deployment of the valve. The flex tip (distal portion of the flex shaft) is hydrophilically coated. The
handle also contains a flex indicator depicting articulation of the flex catheter, a valve alignment wheel for
fine adjustment of the valve during valve alignment, a button that enables movement between handle
positions, and a flush port to flush the flex catheter. The balloon catheter has radiopaque markers