Deployment Of E-Vita Open Neo; Withdrawal Of The E-Vita Open Neo Delivery System After Deployment; Subsequent Steps; Guidelines For Imaging And Follow-Up - Jotec E-vita OPEN NEO Instrucciones De Uso

EN
a. In case the branched graft configuration (see Figure 4) or trifurcated graft configuration
(see Figure 5) is used, ensure that the branches align with the head vessels (see Figure 11
and 12).
b. In case the straight graft configuration (see Figure 3) is used, ensure that the perfusion branch
is not positioned in the area of the planned island (see Figure 10).
6. Ensure that the E‑vita OPEN NEO implant is in the desired position before initiating the deploy-
ment.
7.3

Deployment of E-vita OPEN NEO

CAUTION
• It is not possible to rotate the E-vita OPEN NEO implant via the E-vita OPEN NEO delivery system
once the stent graft part has been fully inserted into the thoracic aorta.
• Make sure that the collar of the E-vita OPEN NEO implant aligns with the transected thoracic aorta
before starting the deployment. Do not rotate the E-vita OPEN NEO delivery system anymore.
• Observe the branch orientation for proper positioning of the device. Start the deployment only if
the branches are in correct orientation.
7. When the E‑vita OPEN NEO implant is in the desired position, begin the deployment.
8. Hold the control handle steadily in position, during deployment.
9. Press the orange release trigger and pull the release handle straight backwards (see Figure
13), until the E‑vita OPEN NEO delivery system locks. While pulling the release handle, the
release wire opens the covering patch and the E-vita OPEN NEO stent graft part gets deployed
(see Figure 14 and 15).
CAUTION
• Make sure that the E-vita OPEN NEO implant remains in the target position during the whole
deployment procedure.
7.4

Withdrawal of the E-vita OPEN NEO delivery system after deployment

10. In case a guide wire is not used, the protective wire has to be removed once the E-vita OPEN
NEO stent graft part is fully deployed (see Figure 7).
11. The E-vita OPEN NEO delivery system can be carefully withdrawn with slight rotational
movements.
NOTE
• For clamping only use atraumatic clamps in order to avoid damage to the polyester fabric.
12. Perform the anastomosis by suturing the collar to the thoracic aorta (see Figure 16).
13. Before perfusion is initiated via perfusion branch, the bypass catheter must be securely fastened
in the perfusion branch.
14. Perform the anastomoses of the vascular graft part to the thoracic aorta.
CAUTION
• Ensure that there is no kinking, torsion or tension on vascular graft part (including branches)
after connection with the native vessels
NOTE
• Only cut the vascular graft by using an electrocautery device.
15. Ensure that by the end of the procedure every branch is connected or tied off (see Figure 17).
7.5

Subsequent steps

16. If a distal extension is needed, follow the instructions for use of that device. The distal overlap
marker of the E-vita OPEN NEO indicates the overlapping.
CAUTION
• For information on the sizing guidelines of other devices, please refer to the appropriate
instructions for use.
8

Guidelines for imaging and follow-up

Computed tomographic angiography (CTA) with 3‑D reconstruction is recommended prior to treat-
ment (within 3 months of implant placement) to determine anatomic suitability for the E‑vita OPEN
NEO. The images should include a non-contrast CT, followed by an early and late phase contrast
CT and should examine the part of the body between the supra-aortic branches and the common
femoral arteries. CT scans should include all sequential images at the lowest possible slice thickness
(< 3 mm). Do not omit consecutive CT images/film sets, as this prevents precise anatomical and
device comparisons over time.
In patients with increased risk of contrast induced nephropathy, circulating volume expansion with
either isotonic sodium chloride or sodium bicarbonate solutions is recommended. Alternatively, mag-
netic resonance angiography (MRA) can be used for preoperative planning in uncomplicated patients.
JOTEC recommends the use of a guide wire during the insertion and deployment of the stent graft
portion into the aorta. The position of the guide wire must be controlled. Transesophageal echocar-
28