Abbott Tendyne TENDV-LP-29S, Instructions For Use Manual

Page: 24 / 284

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.