Endologix Announces 1000 patients treated with the DETOUR™ System

IRVINE, Calif.--(BUSINESS WIRE)--Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, today announced that 1,000 patients have now been treated with Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR System. This milestone includes patients in the DETOUR1 and DETOUR2 clinical studies as well as those treated post-commercial launch (July 2023).

PTAB with the DETOUR System offers a novel approach to treating complex peripheral arterial disease (PAD), enabling physicians to percutaneously bypass lesions in the superficial femoral artery by using stents routed through the femoral vein to restore blood flow to the leg. The DETOUR System is comprised of the ENDOCROSS™ device and TORUS™ stent grafts, providing a minimally invasive alternative to surgical bypass.

"Reaching 1,000 patients treated with the DETOUR System is a significant achievement, demonstrating the growing adoption of PTAB as an important option for patients with complex femoropopliteal disease," said Andrew Davis, Chief Commercial Officer at Endologix. "This milestone underscores our commitment to expanding access to innovative treatments that improve patient outcomes while reducing the need for more invasive procedures."

Upon successfully treating the 1,000th patient on Friday, March 14, 2025, Dr. Sheraz Qureshi from Northwestern Medicine Central DuPage Hospital remarked: "Reaching the 1,000th patient milestone is a testament to the real-world impact this therapy is having. For patients with long SFA disease, this approach is offering a new pathway to better outcomes, improved mobility, and an overall better quality of life”

The DETOUR System has been studied extensively in clinical trials, with results highlighting its durability, safety, and efficacy. The DETOUR2 study, which enrolled 202 patients across 32 sites, demonstrated strong long-term outcomes comparable to open surgical bypass while reducing the length of stay and minimizing the complications associated with open bypass surgery. Post-market adoption continues to show positive real-world performance, reinforcing the role of PTAB with the DETOUR System in the treatment paradigm for complex PAD.

About the DETOUR System

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. The company has offices and manufacturing sites in Irvine, Milpitas 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.