Indications for Use
The AFX® Endovascular AAA Delivery System is indicated for endovascular treatment in patients with AAA. The devices are indicated for patients with suitable aneurysm morphology for endovascular repair, including:
- Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥ 6.5 mm)
- Non-aneurysmal aortic neck between the renal arteries and the aneurysm:
- with a length of ≥ 15 mm
- with a diameter of ≥ 18 mm and ≤ 32 mm
- with a neck angle of ≤ 60° to the body of the aneurysm.
- Aortic length ≥ 1.0 cm longer than the body portion of the chosen bifurcated model.
- Common iliac artery distal fixation site:
- with a distal fixation length of ≥ 15 mm
- with ability to preserve at least one hypogastric artery
- with a diameter of ≥ 10 mm and ≤ 23 mm
- with an iliac angle of ≤ 90° to the aortic bifurcation.
- Extension stent grafts must have the ability to overlap the bifurcated stent graft by at least by at least 30 to 40mm proximally and at least 15 to 20 mm distally.
- Patients who have a condition that threatens to infect the stent graft
- Patients with sensitivities or allergies to the device materials