Skills And Experience Of Physicians; Equipment And Recommended Materials; Planning And Sizing; Product Nomenclature - Jotec E-vita OPEN NEO Gebrauchsanweisung

• Patient's suitability for open surgical repair.
• Vascular morphology of the treated distal aortic segment suitable for endovascular repair, including
○ a distal sealing zone with a length of at least 25 ‑ 33 mm (depending on stent graft diameter)
○ an aortic diameter in the distal landing zone not greater than 40 mm
• Ability to tolerate general anesthesia.
The final treatment decision is at the discretion of the physician and patient.
6.2

Skills and experience of physicians

The planning of the implantation has to be performed by a specialist in open heart surgery procedures,
who is familiar with open heart surgery techniques for the treatment of aneurysms and dissections of
the thoracic aorta. Staff and resources for open surgical intervention are needed as well.
6.3

Equipment and recommended materials

• Operating room (sterile handling), patient must be under cardiac arrest
• Devices commonly used in open surgery, e.g. sutures, needles, scalpel, atraumatic clamps, patches.
• Surgical devices as commonly used in vascular interventional procedures, e.g. soft guide wire,
0.035" (0.89 mm) stiff guide wire (e. g. 300 cm JOTEC E‑wire), multipurpose catheter
NOTE
• Follow the instructions for use of additionally used materials.
6.4

Planning and sizing

6.4.1 Product Nomenclature

95HGYYXXLAAA-C00
95HGYYXXLAAA-C00
95HGYYXXLAAA-C00
95HGYYXXLAAA-C00
95HGYYXXLAAA-C00
95HGYYXXLAAA-C00
95HGYYXXLAAA-C00
Table 2: Explanation of product code.

6.4.2 Oversizing guideline

The E‑vita OPEN NEO is designed to treat aortic diameters between 18 mm and 36 mm in case of
aneurysms, and aortic diameters between 20 mm and 40 mm in case of dissections.
The specific stent graft part diameter should be adequately selected according to the treated disease
using the recommended sizing guidelines (see Table 3 for treatment of aneurysms, Table 4 for
treatment of dissections).
CAUTION
• Vessel over-distension and damage, may be caused by excessive oversizing of the stent graft part
in relation to the diameter of the vessel.
CAUTION
• The treating physician is responsible for selecting the appropriate sizes.
The following table is considered to be a tool for selecting the appropriate size:
Distal aortic diameter [mm]
18
19
20
21
Product Group
95 = E-vita OPEN NEO
Product description
HG = Hybrid graft
Proximal diameter (vascular graft part) [mm]
Distal diameter (stent graft part) [mm]
Length
L = Length
Length stent graft part [mm]
Configuration (Head vessel management)
C01 = straight graft configuration
C02 = branched graft configuration
C03 = trifurcated graft configuration
Aneurysm
Recommended diameter
stent graft part [mm]
20
22
22
24
Minimum length of sealing
zone
25 mm
EN
25