Mr Safety Information; Storage And Packaging; Disposal - Jotec E-vita OPEN NEO Instrucciones De Uso

diography (TEE) or intravascular ultrasound (IVUS) may be helpful to confirm the correct placement
of the guide wire for its full length into the true lumen in case of aortic dissection and to verify the
suitability of distal landing zone.
Physicians should evaluate patients on an individual basis and prescribe follow-up and the required
imaging modalities relative to the needs and circumstances of each individual patient. This schedule
continues to be the minimum requirement for patient follow-up and should be maintained even in
the absence of clinical symptoms.
Post-operative imaging is recommended to include a non-contrast CT, followed by an early and late
phase contrast CT (slice thickness < 3 mm recommended) to provide information on endoleaks,
stent graft migration, component separation, thrombosis, and morphological changes. CT imaging is
recommended to be performed at predischarge or at 1 month, 3 ‑ 6 months, 12 months and yearly
thereafter, if stable condition. MRA may be used to avoid cumulative lifetime radiation exposure and
iodinated contrast media.
After three years follow‑up, the interval of CT or MRI imaging can be extended to two (2) to three
(3) years in patients with stable aneurysm who have no endoleak and no other sign of complication.
Patients with early or late type I and III endoleak, enlarging aneurysm, stent graft migration should
undergo prompt re-intervention. Endovascular procedures should be taken into consideration.
Patients with type II or type IV endoleak or aortic growth > 10 mm should receive enhanced follow-up
with more frequent intervals. Additional CTA (MRA) are recommended at three (3) and six (6) months
after detection.
Care should be taken during planning of follow-up in younger patients regarding the cumulative lifetime
radiation exposure caused by multiple CT examinations. A combination of multi-view chest X-rays
and MRA may be an alternative long-term follow-up in young patients.
Ultimately, it is the physician's responsibility to determine the appropriate imaging schedule for an
individual patient based on previous clinical outcomes and the overall clinical picture.
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MR safety information

MR (magnetic resonance) safety information refers to the use of shielded MR systems with static
magnetic fields (1.5 Tesla or 3.0 Tesla). The implant is MR Conditional. This means that the stent
graft part does not pose any risks to patients undergoing an MR but the stent graft part may impact
the quality of the MR result depending on the pulse and region to be examined.
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Storage and packaging

The E-vita OPEN NEO is a single use product sterilized with ethylene oxide and delivered in sterile
packaging. Product sterility, which is indicated by a sterility indicator, is guaranteed as long as the
packaging remains intact. Store the product in a dark, dry and cool place. Exposure to direct sunlight
is to be avoided. Heat may have a considerable negative effect on product functionality. Do not expose
the product to ionizing radiation or ultraviolet light.
10.1

Disposal

The disposal has to be carried out according to local instructions for clinical waste.
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