Introducing PTAB, the first-ever fully percutaneous transmural arterial bypass therapy using the DETOUR™ System
Under fluoroscopic guidance, the DETOUR System creates a femoropopliteal bypass routed through the femoral vein, delivering unobstructed flow from the superficial femoral artery (SFA) to the popliteal artery.
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The DETOUR System is comprised of the ENDOCROSS™ Device and the TORUS Stent Graft System.
ENDOCROSS Device
The ENDOCROSS Device is a spring-loaded dual guidewire delivery tool that uses a 0.025” Nitinol Needle with a 15 mm throw to create the artery-vein-artery communication.
TORUS Stent Graft
TORUS Stent Grafts are deployed from the popliteal artery into the femoral vein, and from the femoral vein into the superficial femoral artery.
The TORUS Stent Graft is designed with the radial strength to resist forces at the anastomoses sites.
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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.
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.