Navigate Complex PAD with PTAB.
Discover PTAB, the first-ever fully percutaneous transmural arterial bypass therapy using the DETOUR® System Watch VideoEndologix LLC is the legal manufacturer of the company's devices.
PTAB with the DETOUR System
The DETOUR System is comprised of the ENDOCROSS™ Device and the TORUS™ Stent Graft 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.
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.
TORUS Stent Graft Sizes
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Results of the DETOUR System
Clinical Evidence
The development of the DETOUR System has been guided by data, including two multicenter, international clinical studies.
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Rhevera Medical Holdings is the parent company of Endologix LLC. Endologix LLC is the legal manufacturer of the company's devices.
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Indications and Important Safety Information for the DETOUR™ System
INDICATIONS: 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: (1) a distal common femoral artery (CFA) <7 mm in diameter; (2) increased risk of deep vein thrombosis (DVT), such as patients with a recent history of DVT, thrombophilia, and disseminated malignancy; (3) untreated flow-limiting aortoiliac occlusive disease; (4) lack of patent single vessel tibial runoff to ankle; (5) known coagulopathy, bleeding diathesis, or thrombocytopenia that cannot be medically managed; (6) known hypersensitivities, allergies or contraindications to: Nitinol; PTFE; aspirin; heparin; antiplatelet; anticoagulant or thrombolytic therapy; or contrast media that cannot otherwise be medically managed.
WARNINGS: In the DETOUR2 Clinical Study, venous event rates were higher in females than males. This should be considered in patient selection and post-procedure management. Inadvertent, partial, or failed deployment or migration of the stent graft may require surgical intervention.
PRECAUTIONS: (1) Consider recent DVT history in the target limb in case planning and post-procedure anticoagulation as use of the DETOUR System uses a bypass conduit within the femoral vein. (2) Antiplatelet medication should be initiated prior to placement of the stent graft. (3) Effective dual antiplatelet therapy should be maintained following the procedure at a dosage deemed appropriate by the physician. (3) A knee prosthesis may prevent successful and accurate ENDOCROSS Device needle deployment.
POSSIBLE ADVERSE EVENTS related to percutaneous transmural arterial bypass with the DETOUR System include: access vessel occlusion; amputation; aneurysm or pseudoaneurysm; arteriovenous fistula; bleeding complications; death; device or deployment malfunction/failure; drug reactions to antiplatelet agents or contrast medium; edema; embolism; fever in absence of infection; hemorrhage or hematoma; hypotension/hypertension; infection; malposition; migration; myocardial infarction; pain; peripheral ischemia; renal insufficiency or failure secondary to contrast medium; shock; side branch vessel occlusion; stenosis or occlusion; stroke or transient ischemic attack; thrombosis; vessel wall trauma; vessel spasm; venous flow disruption; worsening claudication.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
ATTENTION: See Instructions for Use for a complete listing of Indications, Contraindications, Warnings, Precautions, and Adverse Events.
NOTE: Not all product components are available in every country. Please consult with your Rhevera representative to confirm product availability.
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, Endocross, Torus and Pounce are trademarks of Endologix LLC and its subsidiaries. All other trademarks are the property of their respective owners.
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