18. Detach and withdraw the Angiographic Vessel Dilator with the guidewire from the Catheter Sheath
Introducer by unsnapping the snap-fit at the hub.
Caution: To avoid damage to the Catheter Sheath Introducer tip, do not withdraw the dilator
until the Catheter Sheath Introducer tip is at the desired location in the IVC.
19. Aspirate from the sideport extension to remove any potential air.
20. Determine which end of the cartridge (containing the filter) is to be placed into the hub of the Catheter
Sheath Introducer.
Note: The selected access site will determine the cartridge insertion orientation. The orientation
is identified on the body of the cartridge, femoral is green and jugular is blue. The arrow of the
desired access site will point into the Catheter Sheath Introducer hub.
21. Place the appropriate end of the cartridge into the hub of the Catheter Sheath Introducer until a snap
is achieved (Figure 7).
Figure 7: Cartridge Insertion Into Sheath Hub (femoral shown)
22. Insert the lead wire of the Pusher into the Cartridge.
Note: No resistance should occcur while advancing the pusher wire through the cartridge.
If resistance is felt, withdraw the pusher wire and and reinsert.
23. Slowly advance the filter using the pusher until the leading edge of the delivery marker on the pusher
is positioned just proximal to the end of the filter cartridge.
Note: Once the Option™ ELITE Filter is advanced into the sheath, do not retract then
re-advance the Pusher which may cause premature deployment of the filter.
Note: The delivery marker indicates that the filter is at the distal tip of the Catheter Sheath
Introducer but still fully contained within the sheath (Figure 8).
Note: If filter advancement difficulties arise when using a tortuous vessel approach, stop filter
advancement prior to the curve. Advance the sheath to negotiate the curve and then continue
to advance the filter. Perform filter release (or deployment) under continuous fluoroscopy.
Verify the intended filter location in the inferior vena cava is correct prior to releasing the filter
from the Catheter Sheath Introducer.
Figure 8: Advance Pusher Until Deployment Marker is Adjacent to Cartridge (femoral shown)
24. In order to achieve optimal placement, center the distal end of the Catheter Sheath Introducer in the
vena cava by rotating the entire delivery system, not the Pusher alone.
Note: Check both A/P and Lateral views under angiographic visualization for optimal placement.
25. To deploy the Option™ ELITE Filter, fix the Pusher in position, then pull the sheath back over the
pusher to uncover the filter (Figure 9).
26. Ensure that the Option™ ELITE Filter is fully released and deployed.
27. Carefully remove the Filter Cartridge along with the Pusher, ensuring that the pusher wire does not
interfere with the deployed filter.
Figure 9: Filter Deployment Using Uncover Technique (femoral shown)
28. Place the Sheath Cap on the Catheter Sheath Introducer.
29. Perform a control cavagram prior to terminating the procedure. Verify proper filter positioning.
30. Remove the Catheter Sheath Introducer by placing compression on the vessel above the puncture
site, slowly withdrawing the Catheter Sheath Introducer.
31. Discard the introduction kit and packaging materials.
Note: After use, the introduction kit and packaging materials may be a potential biohazard.
Handle and dispose of in accordance with accepted medical practice and with applicable local,
state and federal laws and regulations.
VIII. Over-the-wire Percutaneous Procedure for Filter Implantation
Pre-implant cavography is required:
w To confirm the patency and visualize the anatomy of the vena cava.
w To mark the level of the renal veins.
w To locate the highest level of any thrombus which may be present.
w To determine the desired level for filter deployment and to mark the position with respect to the
vertebral bodies.
w To confirm that the diameter of the vena cava (AP projection) at the site where the filter is to be deployed
is less than or equal to the maximum authorized diameter (refer to section I Device Description).
1. Select a suitable venous access site, on either the right or left side, depending upon the patient's size
or anatomy, operator's preference or location of venous thrombosis.
2. Prep, drape and anesthetize the skin puncture site in standard fashion.
3. Remove the components of the introduction kit from the package using sterile technique.
4. Remove the pin and flag from the cartridge prior to use (Figure 10).
Figure 10: Removal of Pin and Flag from Cartridge
