Implanting The Valve - St.Jude Medical PRT-23 Mode D'emploi

1. Advance and retract the locking buttons on the delivery system handle (Figure 3). When the buttons are advanced, confirm that the sliding
mechanism moves freely. When the buttons are retracted, confirm that the sliding mechanism locks and the deployment/re-sheath wheel
moves freely.
2. Wet a sterile 4" x 4" (10 cm x 10 cm) gauze with sterile isotonic saline and wipe the shaft of the delivery system.
3. Wet the loading tube in sterile isotonic saline.
4. Slide the loading tube over the protective sheath of the delivery system. Position the distal end of the loading tube below the distal tip of the
protective sheath.
5. Advance the locking buttons to the forward position.
6. Slide the release lever to the right (in the direction of the arrow on the handle).
7. Fully retract the sliding mechanism buttons on the delivery system handle to expose the retainer receptacle.
8. Fill a 20 cc syringe with sterile isotonic saline.
NOTE: Use of a syringe size greater than 20 cc may result in inadequate de-airing.
9. Attach a stopcock and the syringe to the sheath flush port and open the stopcock.
10. Holding the distal tip of the delivery system upright, de-air the system by injecting a minimum of 15-20 cc saline into the sheath flush port. Tap the
loading tube to dislodge any air bubbles while completing the flush.
NOTE: Keep the distal end of the delivery system upright until the valve is completely encapsulated within the delivery system.
11. Close the stopcock and remove the syringe.
12. To facilitate passage of the valve over the radiopaque tip of the delivery system, compress the loading funnel and loading base to slightly open the
aortic end of the valve (Figure 5).
13. Carefully thread the radiopaque tip of the delivery system through the loading funnel and loading base assembly. Guide the three (valve) retainer
tabs to the (delivery system) retainer receptacle.
CaUTION: Carefully insert the radiopaque tip of the delivery system through the center of the valve to avoid damage to the valve or
the delivery system.
14. Engage the three retainer tabs with the retainer receptacle by slightly opening the aortic end of the valve (see step 12 of this section). Visually
confirm that all three retainer tabs are engaged and that no stent struts are overlapping. The ends of the stent struts without retainer tabs should
be aligned with, but not overlapping, the proximal end of the retainer receptacle (Figure 6).
CaUTION: Do not use the valve if the retainer tabs are bent or deformed.
15. Retract the locking buttons on the delivery system handle.
16. Encapsulate the retainer tabs in the protective sheath (Figure 7) by turning the deployment/re-sheath wheel opposite the direction of the arrow
on the handle.
Figure 5
17. Advance the loading tube to form a loose seal with the narrow end of the loading funnel. Align the black indicator line on the loading tube with
the distal end of the protective sheath.
18. Turn the deployment/re-sheath wheel opposite the direction of the arrow on the handle until the funnel is fully seated in the loading tube.
19. Unlock and remove the loading base from the loading funnel.
20. Pour sufficient saline into the loading funnel to cover the valve.
21. Tap the radiopaque tip of the delivery system to remove any air bubbles from the inner shaft.
22. Remove any remaining air bubbles by sliding the leaflet tester from the top to the bottom of each leaflet.
CaUTION: Exercise care to avoid damaging the leaflets with the leaflet tester.
23. Inspect the valve to ensure that no leaflet tissue is trapped between the stent struts. If leaflet tissue is trapped between the stent struts, use the
narrow end of the leaflet tester to move the leaflets inside of the stent.
24. Using the deployment/re-sheath wheel, fully encapsulate the valve in the protective sheath.
NOTE: Grasp the shaft of the delivery system just below the loading tube while encapsulating the valve.
CaUTION: Do not re-sheath the valve more than two times prior to final valve release. additional re-sheath attempts may compromise
product performance.
25. Massage the delivery system shaft from the proximal end to the distal end to close any gap between the protective sheath and the radiopaque tip.
26. Pour the saline out of the loading funnel.
27. Slide the loading funnel and loading tube off the distal end of the delivery system.
28. Fill the syringe with saline, and connect it to the lumen flush port.
29. Slide the delivery system release lever to the left (opposite the direction of the arrow on the delivery system handle).
30. Flush the lumen with sterile isotonic saline.

Implanting the Valve

1. Prepare the vascular access site according to standard practice.
2. Predilate the native aortic valve with an appropriate diameter valvuloplasty balloon.
retainer tab in retainer
Figure 6
receptacle
Figure 7
7
retainer tabs in
protective sheath