Endologix LLC announced that the first patients underwent Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR system, since FDA approval of the system was granted. This marks the official start of its U.S. targeted market release. PTAB with the DETOUR System offers a disruptive, novel approach to treating complex Peripheral Arterial Disease (PAD), enabling physicians to bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein to restore blood flow to the leg.

This approach is effective for patients with long lesions (20cm-46cm in length), those that have already undergone failed endovascular procedures, or those that may be sub-optimal candidates for open surgical bypass. For the rollout, Endologix collaborated with two healthcare systems known for clinical excellence. PTAB using the DETOUR System was first performed at Cleveland Clinic's Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and at Salinas Valley Health Medical Center.

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 diffusestenosis >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. The DETOUR System is contraindicated in patients with: A distal common femoral artery (CFA); 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, Prec precautions, and Adverse Events. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.