Important Safety Information
INDICATIONS FOR USE:
The DETOUR™ System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200mm to 460mm in length with chronic total occlusions (100mm to 425mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR™ System, or any of its components, is not for use in the coronary and cerebral vasculature.
CONTRAINDICATIONS:
The DETOUR™ System is contraindicated in patients with:
- A distal common femoral artery (CFA) <7 mm in diameter.
- Increased risk of deep vein thrombosis (DVT), such as patients with a recent history of DVT, thrombophilia, and disseminated malignancy.
- Untreated flow-limiting aortoiliac occlusive disease.
- Lack of patent single vessel tibial runoff to ankle.
- Known coagulopathy, bleeding diathesis, or thrombocytopenia that cannot be medically managed.
- Known hypersensitivities, allergies or contraindications to: Nitinol; PTFE; aspirin; heparin; antiplatelet; anticoagulant or thrombolytic therapy; or contrast media that cannot otherwise be medically managed.
Refer to Instructions for Use for more information concerning Indications, Contraindications, Specific Anatomic Considerations, Warnings, Precautions, and Adverse Events.
CAUTION:
Federal (USA) law restricts this device to sale by or on the order of a physician.
NOTE: Not all product components are available in every country. Please consult with your Endologix representative to confirm product availability
https://eifu.endologix.com/hcp/endologix/all?keycode=ELX10058
INDICATIONS FOR USE:
The ALTO® Abdominal Stent Graft System is indicated for treatment of patients with infrarenal abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair with the device, which includes the following:
- Adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories,
- A proximal aortic landing zone for the sealing ring 7 mm below the inferior renal artery.
- An aortic sealing zone comprised of healthy aorta defined as:
- Lack of significant thrombus > 8 mm in thickness; at any point along the aortic circumference at the level of 7mm below the inferior renal artery,
- Lack of significant calcification at the level of 7 mm below the inferior renal artery,
- Conicity < 10% as measured from the inferior renal artery to the aorta 7 mm below the inferior renal artery,
- An inner wall diameter of no less than 16 mm and no greater than 30 mm at 7 mm below the inferior renal artery, and
- An aortic angle of ≤ 60 degrees
- A distal iliac landing zone:
- With a length of at least 10 mm, and
- With an inner wall diameter of no less than 8 mm and no greater than 25 mm.
CONTRAINDICATIONS:
The system is contraindicated for use in patients who have a condition that threatens to infect the graft and in patients with known sensitivities or allergies to the device materials including polytetrafluoroethylene [PTFE], polyethylene glycol [PEG]-based polymers, contrast agents, fluorinated ethylene propylene [FEP], titanium, nickel, platinum, or iridium.
Refer to Instructions for Use for more information concerning Indications, Contraindications, Specific Anatomic Considerations, Warnings, Precautions, and Adverse Events.
CAUTION:
Federal (USA) law restricts this device to sale by or on the order of a physician.
NOTE:
Not all product components are available in every country. Please consult with your Endologix representative to confirm product availability.
INDICATIONS FOR USE (US):
The Endologix® AFX®2 Endovascular AAA System is indicated for endovascular treatment in patients with AAA using a surgical vascular access technique or a bilateral percutaneous technique. 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 30 to 40 mm proximally and at least 15 to 20 mm distally.
INDICATIONS FOR USE (EU):
The Endologix® AFX®2 Endovascular AAA System is indicated for endovascular treatment in patients with AAA using a surgical vascular access technique. 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 30 to 40 mm proximally and at least 15 to 20 mm distally.
CONTRAINDICATIONS:
The Endologix® AFX®2 Endovascular AAA System is contraindicated for use in patients who have a condition that threatens to infect the graft and in patients with sensitivities or allergies to the device materials. Refer to the Instructions for Use for more information concerning Indications, Contraindications, Warnings and Precautions, and Adverse Events.
CAUTION:
Federal (USA) law restricts this device to sale by or on the order of a physician. Rx only.
NOTE:
Endologix products and associated components are not available in all countries or regions. Please consult with your Endologix representative for details regarding product availability.
CE marked. Please refer to current product instructions for use.
