Endologix Announces Three-Year DETOUR2 Study Results

Endologix LLC’s DETOUR System is associated with few complications and low deep venous thrombosis rates, according to 36-month DETOUR2 study results.

The company claims the trial data prove the DETOUR System is as safe and effective as open bypass with a synthetic graft. 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 ENDOCROSS device and TORUS stent grafts.

“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, M.D., a study principal investigator and chairman of the Department of Vascular Surgery at Cleveland Clinic.

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 highlight:

• 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 improvement in at least one Rutherford Category at 36 months, was 96.7%.
• The freedom from symptomatic deep venous thrombosis (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.

“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,” Endologix President/CEO Matt Thompson, M.D., stated. “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.”

Percutaneous transmural arterial bypass 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 through 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.

Endologix LLC is a California-based, global medical device company providing innovative therapies for interventional vascular disease treatment. Its therapeutic portfolio includes numerous 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 AFX2 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 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, Calif.