Product Description; E-Vita Open Neo Implant; Overview Of The E-Vita Open Neo Implant; Placement Of Radiopaque Markers - Jotec E-vita OPEN NEO Instrucciones De Uso

E-vita OPEN NEO
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Product Description

E-vita OPEN NEO is intended for the surgical treatment of dissections or aneurysms of the thoracic
aorta. The device was developed on the basis of the E-vita OPEN PLUS Stent Graft System for the
open surgical treatment of aneurysm or dissection in the aortic arch and the descending thoracic
aorta with or without involvement of the ascending aorta.
The E-vita OPEN NEO allows for the treatment of patients in some cases via a single stage Frozen
Elephant Trunk (FET) procedure, dependent on the length of diseased vessel.
The E-vita OPEN NEO consists of two main components:
• The implant, hereinafter referred to as the E-vita OPEN NEO implant, consists of a self-expanding
stent graft part and a conventional vascular graft part.
• The delivery system, hereinafter referred to as the E-vita OPEN NEO delivery system.
E-vita OPEN NEO is delivered sterile.
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E-vita OPEN NEO implant

The E-vita OPEN NEO implant consists of a vascular graft part (see Figure 1, a) and a stent graft part
(see Figure 1, e). These two parts are made of one piece of blood-tight woven polyester.
A black guideline is woven in the fabric at 0° and 180°. The guideline serves as an orientation for
the physician during the operation.
To achieve an adequate sizing of the E-vita OPEN NEO implant, a range of sizes with varying diameters
and lengths in the stent graft part and the vascular graft part are provided. A tapering (see Figure 1, d)
ensures availability of varying vascular graft part and stent graft part sizes and is implemented within
the area of the first stent spring distal to the collar (see Figure 1, b).
A circular collar is attached between vascular graft part and stent graft part to facilitate the suture
line to the aortic wall.

1.1.1 Overview of the E-vita OPEN NEO implant

The vascular graft part of the E-vita OPEN NEO implant has circular crimps that provide the neces-
sary form stability and allow to longitudinal stretching for adaption to the anatomy. At the vascular
graft part, there is a perfusion branch (see Figure 3, a) which may be used for the extracorporeal
perfusion during the intervention.
The stent graft part of the E-vita OPEN NEO implant has self-expanding nitinol stent springs which
are sewn to the polyester fabric to create a lasting radial outward force.
The stent springs have 5 tips and are formed in a symmetrical shape. The orientation of the stent
springs is "tip to valley" with defined distances.
The distal end of the stent graft part provides a double spring design to achieve an adequate sealing
(see Figure 1, g). At the end of the springs the fabric is recessed by wave form cauterization to reduce
infolding of the fabric due to oversizing.
A covering patch is used as an aid for crimping the stent graft part to a smaller outer diameter of
36 F (12 mm), enabling easy insertion into the aorta. It is sewn permanently to the outside of the
stent graft part. The stent graft part will be deployed by releasing the patch through retracting the
release wire. After deployment the covering patch (see Figure 15) remains between the stent graft
part and the aortic wall.
The E‑vita OPEN NEO implant is available in different configurations (see Figure 3, 4 and 5) and
dimensions to facilitate the individual treatment of patients with diseased thoracic aorta.
These three different configurations allow the required head vessel management either by using
branches or the island technique.

1.1.2 Placement of radiopaque markers

Two radiopaque ring markers (see Figure 1, c and 1, h) are sewn to the distal and proximal end
of the stent graft part. This facilitates fluoroscopic visualization under x‑ray and allows visibility for
potential further interventions.
For the treatment of longer aortic segments and placement of further stent grafts, an additional overlap
marker (see Figure 1, f) is placed on the device, showing the recommended minimum overlap length
for a possible extension.
All radiopaque markers are sewn to the outer surface of the fabric.
The E-vita OPEN NEO implant consists of the following materials:
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