Indications For Use; Contraindications - Medtronic Valiant Navion Gebrauchsanweisung

CoveredSeal Tapered configuration
This configuration includes CoveredSeal proximal and distal ends. At the proximal end, a 6-peak (18 Fr or 20 Fr) or 7-peak
(22 Fr) internal stent with a 12-peak (18 Fr or 20 Fr) or 14-peak (22 Fr) W-stent are covered to provide additional fixation while
maintaining transvessel flow. The diameter of the proximal end of the CoveredSeal Tapered configuration is larger than the
diameter of the distal end.
1.2. Delivery system
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1. Luer connector
2. Screw gear
3. Slider handle
4. Trigger
5. Front grip
6. Graft cover
7. Stent stop
8. Tip capture mechanism
9. RO marker band
10. Tapered tip
11. Back-end lock
12. Tip capture release handle
13. Clamping ring
14. Flush port
The Valiant Navion delivery system consists of a single-use, disposable catheter with an integrated handle to provide controlled
deployment. It is available in an outer diameter of 18, 20, and 22 Fr and a working length of 93 cm. The catheter assembly is
flexible and exclusively compatible with a 0.035 in (0.89 mm) guidewire.
A flexible tapered tip is attached to the end of the inner member and provides a smooth transition from the guidewire to the
outer graft cover. The external surfaces of the tapered tip and graft cover are coated with a lubricious hydrophilic coating. Once
activated with a sterile gauze saturated in saline, this coating facilitates vessel access and tracking through the anatomy. A
distal RO marker indicates the graft cover edge under fluoroscopy. The flush port includes a one-way valve that prevents
backflow of flush fluid and maintains hemostasis during the procedure, while allowing the delivery system to be flushed during
device preparation. The stent graft is deployed by rotating or retracting the integrated slider handle. The tip capture release
handle at the rear of the delivery system is unlocked and retracted to release the proximal end of the stent graft.

2. Indications for use

The Valiant Navion thoracic stent graft system is indicated for treatment of diseases of the descending thoracic aorta, including,
but not limited to, aneurysms, dissections, and blunt traumatic aortic injuries (BTAIs). The Valiant Navion thoracic stent graft is
indicated for exclusion of the aneurysm, the false lumen, or site of rupture, and the restoration of blood flow through the stent
graft lumen. The device is intended for use in patients who are candidates for conventional surgical repair, and in patients who
are not candidates for conventional surgical repair due to pre-existing risk factors.

3. Contraindications

The Valiant Navion thoracic stent graft system is contraindicated in the following patient populations:
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Patients who have a condition that threatens to infect the graft
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Patients who are sensitive to or have allergies to the device materials (Table 1)
Also consider the information in Section 4.2 (Warnings and precautions - patient selection, treatment, and follow-up).
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Figure 2. Delivery system
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Instructions for Use English 7