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Remove the stylet and flush the guidewire lumen of the delivery
system.
CAUTION: Keep valve hydrated until ready for implantation.
CAUTION: The physician must verify correct orientation of the
valve prior to its implantation.
8.2.3.2 Procedure with GORE DrySeal Flex Introducer Sheath
1.
Set up two (2) additional sterile bowls with at least 100 ml of sterile
physiological saline to thoroughly rinse the Qualcrimp crimping
accessory.
2.
Completely submerge the Qualcrimp crimping accessory in the first
bowl and gently compress it to ensure complete saline absorption.
Slowly swirl the Qualcrimp crimping accessory for a minimum of
1 minute. Repeat this process in the second bowl.
3.
Remove crimper from packaging.
4.
Rotate the crimper handle until the aperture is fully open.
5.
Remove the valve from the holder and remove the ID tag.
6.
Attach the 2-piece crimp stopper to the base of the crimper and click
into place.
7.
With the crimper in the open position, gently place the valve into the
crimper aperture. Gradually crimp the valve until it fits into the
Qualcrimp crimping accessory.
8.
Place the Qualcrimp crimping accessory over the valve making sure
the valve is parallel to the edge of the Qualcrimp crimping accessory.
9.
Place the valve and Qualcrimp crimping accessory in crimper
aperture. Insert the delivery system coaxially within the valve on the
Valve Crimp Section (2-3 mm distal to the balloon shaft) with the
orientation of the valve on the delivery system with the Inflow (outer
skirt end) of the valve towards the proximal end of the delivery
system.
10. Crimp the valve until it reaches the Qualcrimp stop located on the
2-piece Crimp Stopper.
11. Gently remove the Qualcrimp crimping accessory from the valve.
Remove the Qualcrimp stop from the Final Stop, leaving the Final
Stop in place.
12. Fully crimp the valve until it reaches the Final Stop.
Note: Ensure that the Valve Crimp Section remains coaxial
within the valve.
13. Repeat the full crimp of the valve two more times for a total of three
full crimps.
14. Pull the balloon shaft and lock in default position.
15. Flush the catheter with heparinized saline.
CAUTION: To prevent possible leaflet damage, the valve should
not remain fully crimped and/or in the loader for over
15 minutes.
16. Close the stopcock to the delivery system.
CAUTION: Keep valve hydrated until ready for implantation.
CAUTION: The physician must verify correct orientation of the
valve prior to its implantation.
17. Initiate valve alignment by disengaging the Balloon Lock and
pulling the balloon catheter straight back until part of the Warning
Marker is visible. Do not pull past the Warning Marker.
WARNING: To prevent possible damage to the balloon shaft,
ensure that the proximal end of the balloon shaft is not
subjected to bending.
18. Open the stopcock and flush the flex catheter using heparinized
saline. Close the stopcock.
19. Engage the Balloon Lock.
20. Under fluoroscopy, utilize the Fine Adjustment Wheel to position
the valve between the Valve Alignment Markers.
CAUTION: Do not turn the Fine Adjustment Wheel if the Balloon
Lock is not engaged.
WARNING: Do not position the valve past the distal Valve
Alignment Marker. This will prevent proper valve deployment.
21. Remove the stylet and flush the guidewire lumen of the delivery
system.
8.3 Landing Zone Predilation and Valve Delivery
Landing zone predilation prior to implantation is optional as deemed
appropriate by physician.
Landing zone predilation and valve delivery should be performed under
local and/or general anesthesia with hemodynamic monitoring in a
catheterization lab/hybrid operating room with fluoroscopic imaging
capabilities.
Administer heparin to maintain the ACT at ≥ 250 sec during the
procedure.
CAUTION: Use of excessive contrast media may lead to renal failure.
Measure the patient's creatinine level prior to the procedure.
Contrast media usage should be monitored.
8.3.1 Landing Zone Predilation
Pre-dilate the landing zone, per the discretion of the physician, according
to the instructions for use for the selected balloon catheter.
CAUTION: To minimize the risk of conduit rupture, use caution when
using a balloon with a diameter greater than the nominal diameter
(original implant size) of the conduit for predilation of the intended
deployment site.
8.3.2 THV Delivery
8.3.2.1 Procedure with Edwards Provided Sheath
1.
Gain access using standard catheterization techniques.
2.
Prepare the Edwards sheath. Refer to the Edwards sheath IFU for
information on device preparation and handling.
3.
If necessary, predilate the vessel.
4.
Introduce the sheath per its instructions for use.
5.
Insert the loader assembly into the sheath until the loader stops.
6.
Advance the delivery system, with the Edwards logo in the proper
orientation (the delivery system articulates in a direction opposite
from the flush port), through the sheath until the valve exits the
sheath. Retract the loader to the proximal end of the delivery system.
Note: The delivery system articulates in a direction opposite
from the flush port.
CAUTION: The valve should not be advanced through the sheath
if the sheath tip is not past the IVC bifurcation to minimize the
risk of damage to the iliac vessel(s).
CAUTION: To prevent possible leaflet damage, the valve should
not remain in the sheath for over 5 minutes.
7.
In the vena cava, initiate valve alignment by disengaging the Balloon
Lock and pulling the balloon catheter straight back until part of the
Warning Marker is visible. Do not pull past the Warning Marker.
WARNING: To prevent possible damage to the balloon shaft,
ensure that the proximal end of the balloon shaft is not
subjected to bending.
Engage the Balloon Lock.
Utilize the Fine Adjustment Wheel to position the valve between the
Valve Alignment Markers.
CAUTION: Do not turn the Fine Adjustment Wheel if the Balloon
Lock is not engaged.
WARNING: Do not position the valve past the distal Valve
Alignment Marker. This will prevent proper valve deployment.
CAUTION: Maintain guidewire position during valve alignment.
WARNING: If valve alignment is not performed in a straight
section, there may be difficulties performing this step which
may lead to delivery system damage and inability to inflate the
balloon. Utilizing alternate fluoroscopic views may help with
assessing curvature of the anatomy. If excessive tension is
experienced during valve alignment, repositioning the delivery
system to a different straight section of the vena cava and
relieving compression (or tension) in the system will be
necessary.
8.
Advance the catheter and use the Flex Wheel, if needed, and cross
the landing zone.
Note: Verify the orientation of the Edwards logo to ensure
proper articulation. The delivery system articulates in a
direction opposite from the flush port.
9.
If additional working length is needed, remove the loader by
unscrewing the loader cap and peeling the loader tubing from the
delivery system.
10. Disengage the Balloon Lock and retract the tip of the Flex Catheter
to the center of the Triple Marker. Engage the Balloon Lock.
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