Endologix Unveils 36-Month DETOUR2 Results at 2024 VIVA

Endologix LLC, a global medical device company based in Irvine, California, has announced the final 36-month results of their DETOUR2 Study. This study evaluates the DETOUR System, which provides a novel approach to treating complex peripheral arterial disease (PAD). The system allows physicians to bypass lesions in the superficial femoral artery percutaneously, employing stents routed through the femoral vein to restore blood flow to the leg. The DETOUR System is composed of the ENDOCROSS™ device and TORUS™ stent grafts, showcasing durable efficacy comparable to open bypass using a synthetic graft. Additionally, low complication rates and deep venous thrombosis (DVT) rates underline the favorable safety profile of this innovative technique.

The 36-month outcomes of the DETOUR2 Study were presented at the Late-Breaking Clinical Trial session at VIVA24 on November 5th. Dr. Sean Lyden, a principal investigator and Chairman of the Department of Vascular Surgery at the Cleveland Clinic, presented the findings in a session titled "Final Results of the DETOUR2 Study: Durability of Percutaneous Transmural Arterial Bypass for Treatment of Complex Femoropopliteal Disease." Dr. Lyden emphasized that these extended results indicate that the DETOUR System is comparable to surgical bypass without the need for general anesthesia, which often involves additional complications and longer hospital stays.

Dr. Matt Thompson, President and CEO of Endologix, commented on the potential impact of the DETOUR System on the treatment paradigm for long segment superficial femoral artery (SFA) disease. He expressed confidence in the DETOUR System's ability to provide a less invasive, effective alternative for patients with challenging femoropopliteal lesions. Dr. Thompson also highlighted the company's ongoing commitment to ensuring optimal patient outcomes through rigorous training, continuous data collection, and the PTAB-1 post-market study to further validate these results in real-world settings.

The DETOUR2 Study involved 202 patients across 32 sites, with 200 patients receiving treatment using the DETOUR System. The average lesion length was 32.7 cm, with 96% of cases being chronic total occlusions (CTO), and 70% were severely calcified.

Key results from the study include:
- Freedom from clinically-driven target lesion revascularization (CD-TLR) was 66.8% through three years.
- Primary patency was 58.2% through 36 months.
- Clinical success, defined as an improvement in at least one Rutherford Category at 36 months, was achieved in 96.7% of patients.
- Freedom from symptomatic deep venous thrombosis (DVT) was 95.9% at 36 months.
- Freedom from major lower limb amputation was 98.5% at 36 months.
- The average hospital stay for patients was 1.1 days.

The DETOUR System offers a groundbreaking approach to treating complex PAD. It enables physicians to percutaneously bypass lesions in the superficial femoral artery, using stents routed through the femoral vein via a transmural passage to restore blood flow to the leg. This method is particularly effective for patients with long lesions (20 cm-46 cm), those who have undergone failed endovascular procedures, or those who may not be suitable candidates for open surgical bypass.

Endologix LLC is dedicated to enhancing patients' lives by providing innovative therapies for the interventional treatment of vascular disease. The company's product portfolio includes various offerings in different stages of development, aimed at addressing diseases with significant unmet clinical needs. Endologix’s commercial products, such as the AFX®2 Endovascular AAA System, ALTO® Abdominal Stent Graft System, and the DETOUR™ System, are designed to treat a range of vascular conditions, 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 operates offices and manufacturing sites in Irvine, Milpitas, and Santa Rosa, California.