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IFU, TENDYNE
TM
Mitral Valve System
Page 24 of 284
Cycle Parameters
Method
Temperature
Time
Drying
Time
Option 2:
Prevacuum
Steam
Sterilization
132°C (270°F)
4
Minutes
75
Minutes
Option 3:
Prevacuum
Steam
Sterilization
121°C (250°F)
30
Minutes
75
Minutes
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
TM
valve sizes.
Table 3: Tendyne
TM
Valve Number and Native Valve
Annulus Sizing
Valve Size
Native Valve Annulus Size
AP (mm)
PER (mm)
29S (LP)
26.4
29.5
101
110
29L (LP)
26.4
29.5
110
120
33A (SP)
29.5
33.2
96
104
33B (SP)
29.5
33.2
100
108
33C (SP)
29.5
33.2
105
114
Valve Size
Native Valve Annulus Size
AP (mm)
PER (mm)
33S (SP & LP) 29.5
33.2
111
121
33M (SP &
LP)
29.5
33.2
116
125
33L (SP)
29.5
33.2
121
132
35S (SP & LP) 31.4
35.2
117
127
35M (SP &
LP)
31.4
35.2
122
132
35L (SP)
31.4
35.2
127
138
37S (SP & LP) 33.2
37.2
122
133
37M (SP &
LP)
33.2
37.2
127
138
37L (SP)
33.2
37.2
133
143
39S (SP)
35.0
39.3
127
138
39M (SP)
35.0
39.3
133
143
41S (SP)
36.8
41.3
131
141
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.
Содержание Tendyne TENDV-LP-29S
Страница 27: ...IFU TENDYNETM Mitral Valve System Page 27 of 284 APPENDIX A ...
Страница 50: ...Brugsanvisning TENDYNETM mitralklapsystem Side 50 af 284 BILAG A ...
Страница 155: ...Οδηγίες χρήσης Σύστημα μιτροειδούς βαλβίδας TENDYNETM Σελίδα 155 από 284 ΠΑΡΑΡΤΗΜΑ A ...
Страница 205: ...Bruksanvisning TENDYNETM mitralklaffsystem Side 205 av 284 VEDLEGG A ...
Страница 232: ...Instruções de utilização sistema de válvula mitral TENDYNETM Página 232 de 284 ANEXO A ...
Страница 282: ...Bruksanvisning TENDYNETM mitralisklaffsystem Page 282 of 284 BILAGA A ...
Страница 283: ...IFU TENDYNETM Mitral Valve System Page 283 of 284 ...