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

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IFU, TENDYNE TM Mitral Valve System Page 9 of 284
Figure 5. Tendyne TM Loading Stand
1. Loading Stand Base
2. Left Stand Post
3. Right Stand Post
1.2.5. Tendyne TM Sterile Components
The following additional system components are
provided sterile for use in conjunction with the Tendyne
Mitral Valve System: Tendyne Stand Components
(angled clip, rotating clip, rotating clip head, bottom
loading clip, thumb screws), 1-way and 3-way stopcocks,
hemostasis adapter, Tuohy-Borst valve, valve pocket air
evacuation tube, tether flushing assembly, verification
tether, extension tube, tether clip, and pressure
transducer.
1.3. Tendyne TM Retrieval System
The Tendyne Retrieval System (Figure 6) recaptures and
collapses the valve for removal from the body during
the procedure if the size or final position relative to the
native annulus is suboptimal.
Figure 6. Tendyne
TM
Retrieval System
1. Retrieval Tool Assembly
2. Cable Tie
3. Tuohy Valve
4. Tether Piercing Pin
5. Retrieval Dilator Assembly
6. Retrieval Tool Assembly Rod
7. Scale Markings
8. Retrieval Sheath Assembly
9. Cable Tie Retention Feature
10. Retrieval Front Plate
11. Actuator
12. Slide Bar Locking Mechanism
13. Bottom Thumbscrew
14. Retaining Ring
15. Retaining Ring Thumbscrew
16. Allen Wrench Set (not shown)
17. Insulated Wire Clippers (not shown)
18. 1-Way Stopcock (not shown)
19. Extension tube (not shown)
Indications
The Tendyne Mitral Valve System is indicated for the
treatment of the native mitral valve without prior mitral
valve intervention in patients with moderate-to-severe
or severe mitral valve regur gitation (MR Grade ≥3+), a
life expectancy less than 5 years, left ventricular ejection
fraction (LVEF) ≥ 30%, left ventricular end -diastolic
dimension (LVEDD) ≤ 7.0 cm, who do not have severe
mitral annular calcification and are deemed not suitable
for surgical repair or replacement by a multi-disciplinary
heart team who have:
•
Primary MR and are at prohibitive surgical risk,
deemed not suitable for transcatheter repair by
a multidisciplinary heart team and have left
ventricular end-systolic dimension (LVESD) >
3.0cm, or
• Secondary MR and are symptomatic despite
maximally-tolerated guideline directed medical
therapy (including cardiac resynchronization
therapy, if indicated).
Tendyne Apical Pad: The Tendyne Apical Pad is
intended to secure the valve after Tendyne Mitral Valve
delivery and system withdrawal.
Tendyne Delivery System: The Tendyne Delivery
System is intended for delivery of the Tendyne Mitral
Valve.
Tendyne Loading System : The Tendyne Loading System
is intended for loading of the Tendyne Mitral Valve.
Tendyne Pad Positioning System : The Tendyne Pad
Positioning System is intended for securement of the
Apical Pad.
Tendyne Retrieval System: The Tendyne Retrieval
System is intended for retrieving the Tendyne Mitral
Valve during the procedure, if required.