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.

Endologix^® is a registered trademark of Endologix LLC in the United States, Europe and Japan. All other trademarks are the property of their respective owners.

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