PTAB with the DETOUR System featured in EVT
PTAB with the DETOUR System is clinically proven to be a safe and effective treatment for patients with long complex SFA disease.
CLINICALLY DEMONSTRATED IN PATIENTS WITH UNMET NEEDS:
CD-TLR at 1 year3
occlusion at 1 year1
at 1 year1
at 30 days3
MINIMAL HOSPITAL STAYS
Be one of the first to try PTAB with the DETOUR System
- Lyden. Percutaneous Bypass for Treatment of Long-Segment Femoropopliteal Disease: 12 Month Results from the DETOUR 2 Trial Volume 75, Issue 6, E337-E338, June 2022
- P220021 Summary of Safety and Effectiveness Data (SSED). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
- Lyden et al. Durability of Percutaneous Bypass for Treatment of Femoropopliteal Disease: Two-year Outcomes of the DETOUR-2 Study. VAM 2023
INDICATIONS FOR USE:
The DETOURTM 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 DETOURTM System, or any of its components, is not for use in the coronary and cerebral vasculature.
The DETOURTM 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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