E-Vita Open Neo Delivery System; Overview E-Vita Open Neo Delivery System; Indications; Contraindications - Jotec E-vita OPEN NEO Gebrauchsanweisung

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Components
Springs
Radiopaque markers
Implant
Suture material
Table 1: Components and materials of the E-vita OPEN NEO implant.
1.2

E-vita OPEN NEO delivery system

The E‑vita OPEN NEO delivery system (see Figure 2) is used to introduce the preloaded E‑vita OPEN
NEO implant into the thoracic aorta and is designed for single use only.
It consists of the following components:
• Control handle (see Figure 2, e)
• Atraumatic Tip (36 F) (see Figure 2, a)
• Flap with protective wire (see Figure 2, f)
• Graft protector (see Figure 2, d)
• Pusher (see Figure 2, c)
• Release handle (see Figure 2, h)
• Release trigger (see Figure 2, g)
• Release wire (see Figure 2, b)

1.2.1 Overview E-vita OPEN NEO delivery system

The E-vita OPEN NEO delivery system with E-vita OPEN NEO implant is designed to be introduced
into the opened aorta with or without using a guide wire.
In case a guide wire is used (e.g. dissections), remove the protective wire, insert the guide wire into
the atraumatic tip, and slide the E-vita OPEN NEO delivery system over the guide wire to position
the stent graft part inside the thoracic aorta.
If no guide wire is used, the protective wire remains in the system and can be bent to align the E-vita
OPEN NEO delivery system to the patient's anatomy.
The graft protector and the pusher of the E-vita OPEN NEO delivery system hold the E-vita OPEN
NEO implant in position during insertion and deployment.
For the deployment of the E-vita OPEN NEO implant, the release handle is unlocked by triggering
the orange release trigger. The release handle allows a controlled deployment by pulling the release
wire backwards. The covering patch of the E-vita OPEN NEO implant opens, and the stent graft
part gets deployed.
2

Indications

E-vita OPEN NEO is indicated for the surgical treatment of patients with dissections or aneurysms
having the following characteristics:
• Acute or chronic aortic dissection, DeBakey type I
• Acute or chronic aortic dissection, DeBakey type III, with retrograde progression in the aortic arch;
with or without involvement of the ascending aorta
• Thoracic aortic aneurysm involving the descending thoracic aorta and the aortic arch; with or
without involvement of the ascending aorta
3

Contraindications

E-vita OPEN NEO is contraindicated in:
• Patients with known sensitivities or allergies to nitinol, polyester, platinum-iridium, or polyethylene
• Patients with systemic infection
• Patients with endocarditis or active infection of the aorta.
The final treatment decision is at the discretion of the physician and patient.
4

Warnings and precautions

4.1

General

• Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions
may lead to serious consequences or injury to the patient.
• The E-vita OPEN NEO should only be used by physicians and teams experienced in the diagnosis
and surgical treatment of aortic pathologies, in the frozen elephant trunk procedure and in the use
of this device. The cardiovascular or cardiothoracic surgeon decides if a patient is qualified for a
surgical treatment with the device.
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Material
NiTi - Nickel-titanium alloy (Nitinol)
Platinum-Iridium
Polyester (PET)
UHMWPE (Ultra-high-molecular-weight polyethylene)