IFU, TENDYNE
TM
Mitral Valve System
Page 7 of 284
The Apical Pad is available in a large and a small size. It is
comprised of a PEEK (polyether ether ketone) button
covered by a double velour polyester (PET) fabric. The
nitinol leader and tether are threaded through the
Apical Pad to affix the pad to the epicardial surface of
the heart near the apex. The cam portion of the PEEK
button is moveable to lock and unlock the Apical Pad to
the tether.
Table 1: TENDYNE
TM
Mitral Valve Sizes
Model
Description
Valve
Size
TENDV-LP-29S
Tendyne
TM
Mitral Valve LP
LP
29S
TENDV-LP-29L
Tendyne
TM
Mitral Valve LP
LP
29L
TENDV-SP-33A
Tendyne
TM
Mitral Valve
SP 33A
TENDV-SP-33B
Tendyne
TM
Mitral Valve
SP
33B
TENDV-SP-33C
Tendyne
TM
Mitral Valve
SP
33C
TENDV-SP-33S
Tendyne
TM
Mitral Valve
SP
33S
TENDV-LP-33S
Tendyne
TM
Mitral Valve LP
LP
33S
TENDV-SP-33M
Tendyne
TM
Mitral Valve
SP 33M
TENDV-LP-33M
Tendyne
TM
Mitral Valve LP
LP 33M
TENDV-SP-33L
Tendyne
TM
Mitral Valve
SP
33L
TENDV-SP-35S
Tendyne
TM
Mitral Valve
SP
35S
TENDV-LP-35S
Tendyne
TM
Mitral Valve LP
LP
35S
TENDV-SP-35M
Tendyne
TM
Mitral Valve
SP 35M
TENDV-LP-35M
Tendyne
TM
Mitral Valve LP
LP 35M
Model
Description
Valve
Size
TENDV-SP-35L
Tendyne
TM
Mitral Valve
SP
35L
TENDV-SP-37S
Tendyne
TM
Mitral Valve
SP
37S
TENDV-LP-37S
Tendyne
TM
Mitral Valve LP
LP
37S
TENDV-SP-37M
Tendyne
TM
Mitral Valve
SP 37M
TENDV-LP-37M
Tendyne
TM
Mitral Valve LP
LP 37M
TENDV-SP-37L
Tendyne
TM
Mitral Valve
SP
37L
TENDV-SP-39S
Tendyne
TM
Mitral Valve
SP
39S
TENDV-SP-39M
Tendyne
TM
Mitral Valve
SP 39M
TENDV-SP-41S
Tendyne
TM
Mitral Valve
SP
41S
1.2.
Tendyne
TM
Mitral Valve Delivery System
The Tendyne Mitral Valve Delivery System consists of a
Tendyne
TM
Loading System, Tendyne
TM
Delivery System,
Tendyne
TM
Pad Positioning System, Tendyne
TM
Stand
Components and non-sterile, reusable Tendyne
TM
Loading Stand and Tendyne
TM
Weight. The Tendyne
TM
Retrieval System is also available to retrieve the valve
intraoperatively, in the event the valve implant is
suboptimal.
1.2.1.
Tendyne
TM
Loading System
The Tendyne Loading System (Figure 2) collapses the
Tendyne Mitral Valve into a loading tube. The A2
portion of the Tendyne Mitral Valve aligns with black
marks on the Loading System. The System includes a
Closed Cap, Centering Cap Assembly (Centering Cap,
Centering Rod, Centering Cone, and Thumb Screw),
loading funnel, loading tube, loading handle, and tether
clip.
Summary of Contents for Tendyne TENDV-LP-29L
Page 27: ...IFU TENDYNETM Mitral Valve System Page 27 of 284 APPENDIX A...
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Page 137: ...TENDYNETM 137 284 MR 8 8 1 TendyneTM Tendyne Tendyne Tendyne Tendyne...
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Page 205: ...Bruksanvisning TENDYNETM mitralklaffsystem Side 205 av 284 VEDLEGG A...
Page 232: ...Instru es de utiliza o sistema de v lvula mitral TENDYNETM P gina 232 de 284 ANEXO A...
Page 282: ...Bruksanvisning TENDYNETM mitralisklaffsystem Page 282 of 284 BILAGA A...
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