Abbott Tendyne Gebrauchsanweisung Seite 30

Cycle Parameters
Method Temperature
Option 2:
Prevacuum
132°C (270°F)
Steam
Sterilization
Option 3:
Prevacuum
121°C (250°F)
Steam
Sterilization
CAUTION: Do not use the stand or weight if damage
is detected.
11. Patient Selection and Treatment
Use standard imaging techniques such as Computed
Tomography (CT) angiography and echocardiography to
pre-operatively assess the patient's native mitral valve
and left ventricular dimensions for valve sizing.
Echocardiography imaging at the time of procedure
should be compared with prior imaging for annular and
left ventricular dimensions as a final confirmation for
valve size selection. Once the patient's native mitral
valve and left ventricular dimensions have been
determined, refer to Table 3 for the list of available
Tendyne™ valve sizes.
Table 3: Tendyne™ Valve Number and Native Valve
Annulus Sizing
Native Valve Annulus Size
Valve Size
AP (mm)
29S (LP) 26.4
29L (LP) 26.4
33A (SP) 29.5
33B (SP) 29.5
33C (SP) 29.5
TM
IFU, TENDYNE Mitral Valve System
Drying
Time
Time
4 75
Minutes Minutes
30 75
Minutes Minutes
PER (mm)
29.5 101 110
29.5 110 120
33.2 96 104
33.2 100 108
33.2 105 114
Native Valve Annulus Size
Valve Size
AP (mm)
33S (SP & LP) 29.5
33M (SP & LP) 29.5
33L (SP) 29.5
35S (SP & LP) 31.4
35M (SP & LP) 31.4
35L (SP) 31.4
37S (SP & LP) 33.2
37M (SP & LP) 33.2
37L (SP) 33.2
39S (SP) 35.0
39M (SP) 35.0
41S (SP) 36.8
The assessment of patient suitability for the Tendyne
Mitral Valve treatment and the determination of the
valve model and size to implant shall be based on 3D
modeling of the native mitral valve and the Left
Ventricular Outflow Tract (LVOT) created by implant of
the replacement valve.
NOTE: Pre-procedural imaging and evaluation of the
patient's native mitral valve, underlying pathologic
anatomy, and vessel locations at access site is
essential. In addition, pre-operative CT
reconstruction with appropriate valve size simulation
for neo-LVOT area analysis is critical.
The assessment may determine that concomitant mitral
annulus valvuloplasty be performed to ensure plaque
mobility prior to valve implantation. In such cases,
standard institutional techniques may be used.
Using the pre-operative imaging, it is recommended
that the following conditions are met at both end-
systole and end-diastole:
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PER (mm)
33.2 111 121
33.2 116 125
33.2 121 132
35.2 117 127
35.2 122 132
35.2 127 138
37.2 122 133
37.2 127 138
37.2 133 143
39.3 127 138
39.3 133 143
41.3 131 141