Medtronic Valiant Navion Gebrauchsanweisung Seite 14

■
For treatment of blunt traumatic aortic injuries: non-aneurysmal aortic diameter in the range of 16 mm to 44 mm
■
For treatment of dissections: healthy, non-diseased aortic diameter in the range of 19 mm to 45 mm
■
Nonaneurysmal proximal landing zone ≥ 20 mm (for FreeFlo configuration) and ≥ 25 mm (for CoveredSeal configuration)
and distal neck lengths ≥ 20 mm (for FreeFlo and CoveredSeal configurations) (fusiform and saccular
aneurysms/penetrating ulcers).
■ Proximal landing zone ≥ 20 mm (for FreeFlo configuration) and ≥ 25 mm (for CoveredSeal configuration) (blunt traumatic
aortic injuries, dissections).
6.2. Treatment
6.2.1. Individualization of Treatment
The warnings and precautions previously described in Section 4 should be carefully considered relative to each patient before
use of the Valiant Navion thoracic stent graft system. The risks and benefits should be carefully considered for each patient
before use of the Valiant Navion thoracic stent graft system.
Proper sizing of the device is the responsibility of the physician. Refer to Section 6.3 (Recommended device sizing).
Caution: Vessel damage such as dissection, perforation, or rupture may be caused by excessive oversizing of the stent graft in
relation to the diameter of the blood vessel. Excessive or insufficient oversizing may also result in Type I endoleak. Consider
vessel tortuosity when selecting stent graft length. If preoperative case planning measurements are not certain, an inventory of
system lengths and diameters necessary to complete the procedure should be available to the physician. This approach allows
for greater intraoperative flexibility to achieve optimal procedural outcomes. Using the device outside the recommended
anatomical sizing may result in serious device-related adverse events. Physicians may consult with a Medtronic representative
to determine proper stent graft component dimensions based on the physician's assessment of the patient's anatomical
measurements. However, the final treatment decision is at the discretion of the physician and patient. The benefits and risks
previously described should be carefully considered for each patient before using the Valiant Navion thoracic stent graft
system.
6.2.2. Recommended Skills and Training
The recommended skill/knowledge requirements for physicians using the Valiant Navion thoracic stent graft system are
outlined below:
Patient Selection
■
Knowledge of the natural history of thoracic aortic lesions, including but not limited to thoracic aortic aneurysms, thoracic
aortic dissections, and comorbidities associated with thoracic lesion repair
■ Knowledge of image interpretation, stent graft selection, and sizing
Physician Skills and Experience
All physicians must be trained in the use of the Valiant Navion thoracic stent graft system before using it.
Caution: The Valiant Navion thoracic stent graft system should only be used by physicians and teams trained in vascular
interventional techniques and in the use of this device.
The following list outlines the knowledge and skill requirements for physicians using the Valiant Navion thoracic stent graft
system:
■ Natural history of TAA, fusiform and saccular aneurysms or penetrating ulcers, and comorbidities associated with TAA
■
Radiographic, fluoroscopic, and angiographic image interpretation
■
Angioplasty
■
Appropriate use of anticoagulants (for example, heparin)
■
Appropriate use of radiographic contrast material
■ Embolization
■ Endovascular stent graft placement
■
Femoral cutdown, arteriotomy, and repair
■
Nonselective and selective guidewire and catheter techniques
■
Snare techniques
■
Techniques to minimize radiation exposure
■ Device selection and sizing
Materials Recommended for Device Implantation
At the time of surgery, Medtronic recommends that the physicians have the following materials available:
12 Instructions for Use English