The reimbursement information provided above has been obtained from third party sources and is intended to be used as a general source of information only. It does not cover all possible patient care situations, payer rules, or scenarios. It is solely the provider’s responsibility to determine the proper medical products and services to be provided to individual patients, and to report the procedures and codes, if any, that most appropriately describe the products or services rendered. Endologix does not promise or guarantee coverage or payment by Medicare or any other payers by providing this information. The information does not constitute legal advice and no warranty regarding the completeness or accuracy of the information is made or implied. The information provided is subject to change without notice as reimbursement laws, regulations, rules and policies change frequently. Providers must seek advice from Medicare and/or other specific payers to obtain the most accurate, current and appropriate information related to pre-authorization, coverage, billing and reimbursement. Endologix specifically disclaims and rejects any liability or responsibility for any actions or consequences resulting from the use of this information.
DETOUR® System
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.
Endologix is a registered trademark of Endologix LLC in the United States, Europe and Japan, and Rhevera, Rhevera Medical, the Rhevera logo, ALTO, AFX, Detour and Pounce are trademarks of Endologix LLC and its subsidiaries. All other trademarks are the property of their respective owners.
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