DETOUR Evidence

Embrace
the evidence.

We have embraced a data-driven approach to the development of the DETOUR™ System.

PTAB with the DETOUR System is clinically proven to be a safe and effective treatment for patients with long complex SFA disease.

The DETOUR2 Study is a prospective, single-arm, multicenter, international clinical investigation to evaluate the safety and effectiveness of the DETOUR System.

CLINICALLY DEMONSTRATED IN PATIENTS WITH UNMET NEEDS:

0 cm
mean
lesion length1
0 %
chronic total occlusion before the DETOUR System1
0 %
of enrolled patients had in-stent-restenosis1
0 %
had previous peripheral intervention1
Clinical evidence demonstrates PTAB using the DETOUR System is a safe and effective treatment option for patients with long complex SFA disease.

DEMONSTRATED EFFICACY

0 %
freedom from
CD-TLR at 2 year3
0 %
freedom from 100%
occlusion at 2 year3
0 %
clinical success*
at 2 year4

DEMONSTRATED SAFETY

0 %
infection rate
at 30 days3
0 %
freedom from major adverse events at 30 days1
0 %
DVT rate at
30 days1

MINIMAL HOSPITAL STAYS

0 DAY
average hospital stay
post-procedure3
*Clinical success is defined as an improvement in limb ischemia with a scale increase of ≥1 according to the Rutherford Classification.

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REFERENCES
  1. 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
  2. P220021 Summary of Safety and Effectiveness Data (SSED). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
  3. Lyden et al. Durability of Percutaneous Bypass for Treatment of Femoropopliteal Disease: Two-year Outcomes of the DETOUR-2 Study. VAM 2023
  4. The DETOUR System IFU 117 Rev A
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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.

CONTRAINDICATIONS:
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.

©2024 Endologix LLC. All rights reserved. MM2634-US Rev 03

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Endologix® products and associated components are not available in all countries or regions. Please contact your Endologix representative for details regarding product availability. Prior to use, refer to the “Instructions for Use” for complete and specificindications, contraindications, all warnings and precautions. Rx only.

Disclaimer:

The DETOUR™ System and associated components: ENDOCROSS Device and TORUS Stent Graft System are only available in the United States.

Please contact your Endologix representative for details regarding product availability.

If you are an HCP practicing in the United States:

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Prior to use, refer to Instructions for Use for more information concerning Indications, Contraindications, Specific Anatomic Considerations, Warnings, Precautions, and Adverse Events. Rx only.
© Endologix LLC. All rights reserved.