Heparinization; Implantation Procedure; Preparation; Insertion And Positioning - Jotec E-vita OPEN NEO Instrucciones De Uso

CAUTION
• For information on the sizing guidelines of other devices, please refer to the appropriate instruc-
tions for use.
6.5

Heparinization

Systemic anticoagulation should be used during the implantation procedure based on hospital and
physician preferred protocol. If heparin is contraindicated, an alternative anticoagulation should be
considered.
7

Implantation procedure

CAUTION
• Before starting the operation, read the entire description of the implantation procedure.
The E-vita OPEN NEO is designed to be introduced into the opened thoracic aorta. The treatment with
an E-vita OPEN NEO contains the following steps.
7.1

Preparation

1. Unpack the E-vita OPEN NEO.
CAUTION
• Do not use the product, if the sterile barrier is damaged.
• The inner pouch must only be opened in the sterile field.
• Only the inner pouch of the sterile barrier may enter the sterile field.
NOTE
• Take care while unpacking the E-vita OPEN NEO to avoid any event which could make the
product unsterile.
CAUTION
• Do not use the product if it shows obvious damage.
7.2

Insertion and positioning

CAUTION
• Do not bend the system without a wire inside.
2. Expose the access point by the usual surgical technique.
3. Using of a guide wire
a. It is recommended to introduce the E-vita OPEN NEO into the thoracic aorta by using a guide
wire. Insert a super stiff 0.035" (0.89 mm) guide wire (e.g. JOTEC E‑wire) using the femoral
endovascular access (see Figure 6).
NOTE
• In case a guide wire is used, the protective wire has to be removed first (see Figure 7).
• Please, refer to the relevant instructions for use of additionally used materials.
• Insert the guide wire immediately after removal of the protective wire.
WARNING
• In case of dissection, ensure that the E-vita OPEN NEO implant is placed in the true lumen,
e.g., by using a guide wire.
b. In case a guide wire is not used, it is possible to preshape the loaded stent graft part
(see Figure 8).
NOTE
• Using a guide wire, preshaping of the loaded stent graft part is not necessary.
CAUTION
• The stent graft part must be preshaped only with the protective wire inside the E-vita OPEN
NEO delivery system.
• Do not preshape the loaded stent graft part into a radius smaller than 25 mm
• Preshape the loaded stent graft part only in the direction indicated in the drawing.
CAUTION
• Ensure a proper planning of the surgical procedure. The implant size must be in accordance with
the information gathered at pre- and intraoperative planning.
4. Introduce the E‑vita OPEN NEO carefully in orientation to the target position of the head vessels
via the guide wire in antegrade direction into the opened thoracic aorta (see Figure 9).
WARNING
• If resistance is felt when introducing the E-vita OPEN NEO delivery system with loaded E-vita
OPEN NEO implant, do not advance further. Discontinue, locate and eliminate the source of
the resistance.
5. Advance the E-vita OPEN NEO until the collar of the E-vita OPEN NEO implant aligns with the
transected thoracic aorta.
EN
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