Endologix LLC, a global leader in medical devices for vascular disease, today revealed the final 36-month results of its DETOUR2 Study. The DETOUR System provides an innovative solution for treating complex peripheral arterial disease (PAD) by enabling physicians to bypass lesions in the superficial femoral artery using stents routed through the femoral vein. This approach restores blood flow to the leg with the use of the ENDOCROSS™ device and TORUS™ stent grafts. The DETOUR2 results show that the DETOUR System offers durable efficacy comparable to open bypass surgery with synthetic grafts, while also maintaining a favorable safety profile, with low rates of complications and deep venous thrombosis (DVT).
The final 36-month results of the DETOUR2 Study were presented on November 5th during the Late Breaking Clinical Trial session at VIVA24 by principal investigator Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic. The presentation, titled “Final Results of the DETOUR2 Study: Durability of Percutaneous Transmural Arterial Bypass for Treatment of Complex Femoropopliteal Disease,” highlighted the long-term effectiveness of the DETOUR System in treating complex peripheral arterial disease (PAD).
“These extended results reinforce that the DETOUR system is comparable to surgical bypass but offers the benefit of avoiding general anesthesia, which can carry additional risks and longer recovery times,” said Dr. Lyden.
Matt Thompson, MD, President and CEO of Endologix, emphasized the potential of the DETOUR System to change the treatment landscape for long segment superficial femoral artery (SFA) disease. “The 36-month data confirms the DETOUR System as a less invasive and effective alternative for treating complex femoropopliteal lesions. Moving forward, we will continue to focus on ensuring optimal outcomes for patients through rigorous training, data collection, and the PTAB-1 post-market study to validate these findings in real-world settings.”
The DETOUR2 Study involved 202 patients across 32 sites, with 200 patients treated using the DETOUR System. The study primarily focused on patients with long, challenging lesions (mean length: 32.7 cm), including 96% with chronic total occlusions (CTO) and 70% with severe calcification.
Key results from the 36-month follow-up include:
- Freedom from CD-TLR (Clinically Driven Target Lesion Revascularization): 66.8%
- Primary patency: 58.2%
- Clinical success (improvement in at least one Rutherford Category): 96.7%
- Freedom from symptomatic deep vein thrombosis (DVT): 95.9%
- Freedom from major lower limb amputation: 98.5%
- Average hospital stay: 1.1 days
About the DETOUR System
The DETOUR System provides a novel approach for treating complex PAD, allowing physicians to bypass lesions in the superficial femoral artery by using stents routed through the femoral vein via a transmural passage. This technique is particularly beneficial for patients with long lesions (20–46 cm), those who have undergone failed endovascular procedures, or those deemed poor candidates for open surgical bypass.
About Endologix
Endologix LLC is a global medical device company headquartered in California, dedicated to improving patient outcomes through innovative therapies for the interventional treatment of vascular disease. The company’s portfolio includes products designed to address unmet clinical needs in treating vascular conditions, including the AFX®2 Endovascular AAA System, ALTO® Abdominal Stent Graft System, and the DETOUR™ System. Endologix is owned by Deerfield Management, a healthcare-focused investment firm. The company operates offices and manufacturing sites in Irvine, Milpitas, and Santa Rosa, California.
