CoreValve Transcatheter Aortic Valve Implantation System
Preparation and Loading Procedure
®
Please refer to Instructions for Use for complete procedural information.
Step 2
Normal Indicator
Indicator Showing
Freeze Damage
Step 3
Step 6-7
Step 9
Macro Slider
10 Catheter Flush
1. Before removing the CoreValve Bioprosthesis from
its packaging, carefully inspect the packaging for any
evidence of damage. If there is evidence of damage, do
not use the valve.
2. Inspect the freeze indicator located within the packaging
for any evidence of damage. If there is evidence of
damage, do not use the CoreValve Bioprosthesis.
Step 12
3. Remove the CoreValve Bioprosthesis from its container
by carefully grasping one of the frame loops with a pair
of blunt-tipped forceps. DO NOT use the forceps to grasp
the tissue portion of the valve.
4. Compare the serial number on the container with the
serial number on the tag attached to the CoreValve
Bioprosthesis. If the serial numbers do not match,
DO NOT use the valve.
5. Remove the serial number tag from the CoreValve
Bioprosthesis and set it aside. Ensure that the suture
that was used to secure the serial number tag to the
CoreValve Bioprosthesis is completely removed from
the valve.
Step 13
=
CoreValve Bioprosthesis loading steps
should be performed under chilled
(0-8°C) saline
6. Rinse the CoreValve Bioprosthesis by immersing it in a
sterile basin containing 500 mL of fresh saline. Gently
agitate the valve by hand for 2 minutes to ensure that
the glutaraldehyde and alcohol are thoroughly rinsed
from the valve.
7. Repeat step 6 two more times (for a total of 3 times)
using 500 mL of fresh saline each time to ensure
complete removal of glutaraldehyde and alcohol from
the CoreValve Bioprosthesis.
Step 15
Micro Knob
11 Guidewire Lumen Flush
8. Wipe the length of the Delivery Catheter System (DCS)
with a moist (saline) gauze.
9. Use the macro and micro knobs on the handle to open
and close the DCS.
10. Attach a stopcock to the distal luer-lock connection on
the handle. Insert a 10-ml syringe filled with saline in
the stopcock and flush. For DCS w/ AccuTrak™ Stability
Layer, repeat flushing procedure for the second flush
tube. Verify there is no leakage from the catheter, if
leakage is observed use a new DCS.
11. Attach a 10-ml syringe filled with saline in the proximal
luer-lock connection on the handle and flush.
Step 17
Step 18
12. Advance the flared outflow tube over the DCS shaft.
Step 19
19. Carefully withdraw the inflow tube and attach the
exposed frame loops to the DCS tabs.
Step 24
24. Advance the CoreValve Bioprosthesis into the inflow
cone while holding the flared outflow tube.
Step 27
13. Using chilled (0-8°C) saline, submerge and cool the
15. Once the CoreValve Bioprosthesis is fully inserted,
CoreValve Bioprosthesis. Gently squeeze the outflow
secure the outflow cap onto the outflow cone.
part of the cold valve frame and insert into the outflow
cone. Note: As applicable, all subsequent CoreValve
Bioprosthesis loading steps should be performed under
chilled (0-8°C) saline.
14. Slowly continue to insert the frame into the outflow cone.
Step 20
20. Cover the frame loops and the top of the CoreValve
Bioprosthesis struts with the capsule using the micro
knob. Ensure that the outflow struts are all captured
prior to advancing the capsule further.
Step 25
25. Advance the CoreValve Bioprosthesis into the inflow
cone until the outflow tube contacts the inside of the
inflow cone.
Step 21
16. Carefully insert the inflow tube (non-tapered) into the
outflow cap.
17. Gently continue to advance the inflow tube until the
frame loops begin to separate.
18. Insert the distal tip of the DCS into the inflow tube.
Step 22-23
21. Advance the outflow tube over the radiopaque marker
band of the capsule.
Step 26
22. Remove the outflow cap and inflow tube from the
outflow cone.
23. Move the outflow cone away from the CoreValve
Bioprosthesis over the DCS towards the handle.
Tip
26. Slowly advance the capsule over the CoreValve
Bioprosthesis to within approximately 5 mm of the
DCS tip.
Tip: If the micro knob clicks, apply mild upward pressure to the
macro slider and continue turning the micro knob.
www.medtronic.com
Tip
World Headquarters
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
Tel: (763) 514-4000
Fax: (763) 514-4879
Medtronic USA, Inc.
Toll-free: 1 (800) 328-2518
(24-hour technical support for
physicians and medical professionals)
LifeLine
CardioVascular Technical Support
Tel: (877) 526-7890
Tel: (763) 526-7890
Fax: (763) 526-7888
E-mail: [email protected]
Europe
Medtronic International Trading Sàrl
Route du Molliau 31
Case postale
CH-1131 Tolochenaz
Switzerland
Tel: 41.21.802.7000
Fax: 41.21.802.7900
Canada
Medtronic of Canada Ltd.
6733 Kitimat Road
Mississauga, Ontario L5N 1W3
Canada
Tel: (905) 826-6020
Fax: (905) 826-6620
Toll-free: 1 (800) 268-5346
Asia Pacific
Medtronic International, Ltd.
16/F Manulife Plaza
The Lee Gardens, 33 Hysan Avenue
Causeway Bay
Hong Kong
Tel: (852) 2891 4456
Fax: (852) 2891 6830
[email protected]
Latin America
Medtronic USA, Inc.
Doral Corporate Center II
3750 NW 87th Avenue Suite 700
Miami, FL 33178
USA
Tel: (305) 500-9328
Fax: (786) 709-4244
UC201006084 EE © Medtronic, Inc. 2010 All Rights Reserved Not for distribution in the USA Printed in Europe
CoreValve Bioprosthesis After Finished Load
27. Submerge the capsule into cold saline and flush the
distal luer-lock connection on the handle. For DCS w/
AccuTrak™ Stability Layer, repeat flushing procedure for
the second flush tube.
28. Slowly advance the capsule over the CoreValve
Bioprosthesis until the capsule contacts the DCS tip.
Remove the outflow cone and outflow tube from the
DCS. Maintain the loaded CoreValve Bioprosthesis in
cold saline until it is ready to be implanted in the patient.
201006084_EE.indd 1
Tip: If the micro knob has fully advanced the capsule and
a small gap remains between the capsule and the catheter
tip, position one hand below the capsule, stabilize the
handle with the other hand and gently advance the capsule
manually to close the gap.
Maintain the loaded CoreValve Bioprosthesis in cold saline
until it is ready to be implanted in the patient.
CAUTION: The CoreValve® System is not
available in the USA, Canada or Japan for
clinical trials or for sale.
Refer to Instructions for Use for a complete list of warnings, precautions and
contraindications.
CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l.
AccuTrak is a trademark of Medtronic, Inc.
24/08/2010 14:26