Idiomas disponibles
Idiomas disponibles
Use echocardiography and a push-pull test (see step 20) to evaluate the position of the device after device
deployment, but before detachment. If the device position after deployment is not secure, consider the use of a larger
device (30 mm or 35 mm).
If the device interferes with an adjacent cardiac structure (such as free atrial wall or aortic root), recapture the device
and redeploy. If device position remains unsatisfactory, recapture the device and either replace with a smaller device
or consider alternative treatments. Refer to Table 1 in Appendix A: Supplemental Information and Table 2 (above) for
device selection and sizing guidelines. Check SVC, inferior vena cava (IVC) and coronary sinus (CS) flows after
device deployment, but before detachment.
CAUTION: Care should be taken not to entrap right atrial Chiari networks or large Eustachian valves under the
right atrial side of the device.
WARNING: Use echocardiography to ensure that the device does not impinge on the free atrial wall or aortic
root.
7. Prepare the Amplatzer™ Talisman™ PFO Occluder for use:
a. Inspect the sterile package. Do not use the device if the sterile package is open or damaged.
b. Open the sterile package and inspect the PFO occluder, Amplatzer™ Trevisio™ delivery cable, loader, and
hemostasis valve. Do not use if damage is observed or if the occluder is detached from the cable.
c. Remove the device with attached delivery accessories from the package (delivery cable, loader, and hemostasis
valve) and ensure the connection is secure between the loader and the hemostasis valve.
d. Ensure the PFO occluder is appropriately attached to the delivery cable:
- Rotate the occluder one full turn counter-clockwise.
- Rotate occluder clockwise until resistance is felt.
- Rotate occluder counter-clockwise 1/8 of one turn to facilitate device release upon deployment.
NOTE: If the occluder detaches from the delivery cable, re-attach it to the distal end of the delivery cable by rotating the
device clockwise approximately 4 to 5 turns until it is secure. Then, rotate the device counter-clockwise 1/8 of one turn
to facilitate occluder release during implantation.
8. Load the occluder in the loader.
a. Flush the loader and hemostasis valve with sterile saline.
b. With the occluder and distal end of the loader submerged in sterile saline, pull back on the delivery cable to retract
the device inside the loader until the distal marker band of the occluder reaches the loader tip.
9. Flush sterile saline through the hemostasis valve until no air bubbles are visible on the loaded occluder.
NOTE: The attachment of the occluder to the cable may be checked after loading by rotating the cable clockwise until
resistance is felt, then rotating the cable counter-clockwise 1/8 turn.
10. Prepare the Amplatzer™ Talisman™ Delivery Sheath according to the Amplatzer™ Talisman™ Delivery Sheath
instructions for use.
11. Insert the dilator into the delivery sheath and tighten the rotating luer.
12. Advance the dilator and delivery sheath over the guidewire, through the PFO, and into the left atrium, confirming
correct movement via echo and/or fluoroscopy.
WARNING: Do not advance the dilator and delivery sheath if resistance is felt.
13. Slowly remove the guidewire and dilator to prevent ingress of air; allow blood back-flow to purge all air from the
system.
14. While maintaining a wet-to-wet condition, attach the loader to the delivery sheath and tighten the rotating luer to lock
the components together.
15. Advance the delivery cable and occluder through the delivery sheath until the occluder reaches the tip of the sheath. A
mark on the cable indicates the occluder is nearing the end of the sheath.
7
