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Note: If the inner diameter of the original access catheter is sufficient for the
selected device size, that catheter may be used for device delivery.
It is recommended to select a catheter that has a straight or multipurpose tip curve
configuration.
4. Access the paravalvular leak and perform an angiogram using standard technique
to visualize the desired occlusion site.
5. Advance the delivery catheter over the guide wire until the distal tip is at the leading
edge of the occlusion site.
6. Remove the guide wire.
7. Prepare the device for use:
- Inspect the sterile (outer) pouch and verify that it is unopened and undamaged.
Do not use the device if the sterile pouch is open or damaged. Note that inside the
sterile pouch, the valvular plug is covered with a protective sleeve that is not
intended to be sealed.
- Gently open the sterile pouch and inspect the components for damage. Do not
use the device if it has been damaged.
8. Pull the loader away from the hoop dispenser to expose a section of the delivery
wire.
9. Submerge the device and the tip of the loader in sterile saline. While holding the
loader steady, grasp the delivery wire near the hub of the loader and pull the
delivery wire in a proximal direction to retract the device into the loader. The device
is properly loaded when the entire device is compressed within the loader and the
distal marker band is no more than 1 cm from the distal end of the loader.
10. Do not retract the device so far that the distal end of the device is more than 1 cm
from the distal end of the loader. Retracting the device too far may prevent the
device from deploying properly.
11.
Push the delivery wire back into the hoop dispenser, then reconnect the loader to
the hoop dispenser.
12. Purge air from the loader and device by flushing the hoop dispenser and loader with
sterile saline (using a 20-cc syringe) until saline exits the distal tip of the loader.
13. Remove the loader and the delivery wire from the hoop dispenser.
14. Insert the loader through the Y-connector into the delivery catheter.
15. Allow blood backflow or aspirate the system to ensure that air is purged from the
catheter and the loader.
16. Advance the delivery wire to move the device into the delivery catheter. Remove the
loader from the wire if desired.
17. Advance the delivery wire and device to the distal end of the delivery catheter.
WARNING: Do not twist or rotate the delivery wire or the device may detach
prematurely.
18. Hold the delivery wire in place and slowly withdraw the delivery catheter to deploy
the distal lobe of the device at the occlusion site.
19. The orientation of the device in the paravalvular space may be determined using the
platinum marker. If a different orientation of the device in the paravalvular space is
desired, readvance the delivery catheter to recapture the device within the catheter,
then rotate the entire delivery system to reposition the device in the paravalvular
space.
WARNING: Do not twist or rotate the delivery wire or the device may detach
prematurely.
20. If the position and orientation of the device in the paravalvular space are
satisfactory, withdraw the delivery catheter to completely deploy the device.
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