Endologix Announces 36-Month Results of DETOUR- 2 Study at 2024 VIVA Late-Breaking Clinical Trial Session
The DETOUR2 Trial is a prospective, single-arm, international, multi-center clinical evaluation of the novel DETOURTM System for fully percutaneous femoropopliteal bypass procedures.
IRVINE, Calif. November 5, 2024— Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, today announced the final 36-month results of the DETOUR2 Study. The DETOUR System offers a unique 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 ENDOCROSSTM device and TORUSTM stent grafts. The DETOUR2 Study findings highlight the durable efficacy of the DETOUR System, which is comparable to open bypass with a synthetic graft. Additionally, the low rates of complications and deep venous thrombosis (DVT) demonstrate the favorable safety profile of this novel technique.
The 36-month results from the study were presented at the Late Breaking Clinical Trial session at VIVA24 on Tuesday, November 5th and titled “Final Results of the DETOUR2 Study: Durability of Percutaneous Transmural Arterial Bypass for Treatment of Complex Femoropopliteal Disease” by one of the study’s principal investigators, Sean Lyden, MD, Chairman of the Department of Vascular Surgery at Cleveland Clinic’. “These extended results from the DETOUR2 study help continue to demonstrate using the DETOUR system is comparable to surgical bypass but without requiring general anesthesia, which can come with additional complications and longer length of stay,” said Sean Lyden, MD.
“The 36-month data from the DETOUR2 Study underscores the potential of the DETOUR System to significantly impact the treatment paradigm for long segment SFA disease,” said Matt Thompson, MD, President, and CEO of Endologix. “We are confident in the DETOUR System’s ability to offer a less invasive, effective alternative for patients with challenging femoropopliteal lesions. As we move forward, our focus remains on ensuring optimal patient outcomes through rigorous training, ongoing data collection, and the PTAB-1 post-market study to further validate these results in real-world settings.”
The DETOUR2 Study enrolled 202 patients at 32 sites, and 200 patients were treated with the DETOUR System. The mean lesion length was 32.7 cm, 96% were chronic total occlusions (CTO), and 70% were severely calcified.
The results presented highlight:
- Freedom from CD-TLR was 66.8% through 3 years.
- Primary patency was 58.2% through 36 months.
- Clinical success, defined as improvement in at least one Rutherford Category at 36 months, was 96.7%.
- The freedom from symptomatic DVT was 95.9% at 36 months.
- The freedom from major lower limb amputation was 98.5% at 36 months.
- Average length of hospital stay was 1.1 days.
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 DETOURTM System, are designed to treat a range of vascular diseases, from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix is wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. 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.
Media Contact
Media inquiries: media@endologix.com
