JSCAI-published data from one of the first studies in long-segment (>30 cm) FP disease show durable patency, low reintervention rate, and high limb salvage through 36 months
SANTA ROSA, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company focused on advancing innovative therapies for the interventional treatment of vascular disease, today announced publication of 36-month results from the DETOUR2 clinical trial evaluating Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR™ System in the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI).
The DETOUR2 Trial is a prospective, single-arm, international, multi-center clinical evaluation of the safety and effectiveness of PTAB using the DETOUR System in patients with long and complex femoropopliteal lesions. The prospective, multicenter, international study enrolled 202 patients across 32 clinical sites and results demonstrated sustained safety and durable clinical outcomes through 36 months, supporting PTAB with the DETOUR System as a minimally invasive alternative for patients with complex peripheral arterial disease (PAD). This publication comes on the heels of additional progress with the PTAB1 study, a prospective, multi-center, real-world registry evaluating the safety and clinical performance of the DETOUR System, which has now enrolled more than 200 patients and is tracking outcomes in patients with complex, long-segment PAD.
“Long-segment femoropopliteal disease remains one of the most challenging areas in peripheral vascular intervention,” said Dr. Prakash Krishnan, MD, Icahn School of Medicine at Mount Sinai and lead author of the study. “The DETOUR2 results demonstrate that percutaneous bypass using the DETOUR System can deliver durable outcomes through three years with favorable safety, providing an important treatment option for patients with complex SFA disease.”
The study shows strong long-term outcomes in a highly complex SFA disease patient population with a mean lesion length of 32.7 cm, 96% chronic total occlusions (CTO), and 70% severely calcified lesions. Key results through 3 years:
- Primary patency at 36 months: 58.2%
- Patency defined as freedom from occlusion (flow/no flow): 84.0%
- Freedom from clinically driven target lesion revascularization (CD-TLR): 66.8%
- Freedom from major adverse limb events (MALE): 64.5%
- Freedom from major amputation: 97.9% (unchanged from 12m)
- Symptomatic deep vein thrombosis (DVT): 4.1%, with no pulmonary emboli reported (unchanged from 12m)
Clinical success, defined as improvement in Rutherford clinical classification, was achieved in 96.7% of patients at 36 months, reflecting sustained improvement in symptoms and functional status.
“These findings highlight the durability of PTAB with the DETOUR System in treating long, complex lesions that historically have required open surgical bypass,” said John Liddicoat, President and CEO of Endologix. “The ability to deliver comparable durability with a minimally invasive procedure represents a meaningful advancement for physicians and patients managing complex peripheral arterial disease.”
To view the published study, visit: https://www.jscai.org/article/S2772-9303%2826%2901204-4/fulltext
PTAB with the DETOUR System offers a novel approach to treating complex PAD, enabling physicians to bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein via a transmural passage, 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.
About Endologix
Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have clinically relevant unmet needs. Endologix’s commercial products, including the AFX®2 Endovascular AAA System, ALTO® Abdominal Stent Graft System, and the DETOUR™ System, are designed to treat a range of vascular diseases, from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix is a portfolio company of investment funds managed by Deerfield Management, a firm committed to advancing healthcare through investment, intelligence, and philanthropy. The company has offices and manufacturing sites in Irvine and Santa Rosa, California. To learn more about Endologix, please visit https://www.endologix.com.
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.
- 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.
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