DETOUR2 Trial Shows Promising Results for Treating Complex SFA Disease

Endologix announces one-year results of DETOUR2 Trial, demonstrating efficacy of DETOUR System in treating complex superficial femoral artery disease. The system shows low complication rates, excellent primary patency, and minimally invasive approach.

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Bijay Laxmi
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DETOUR2 Trial Shows Promising Results for Treating Complex SFA Disease

DETOUR2 Trial Shows Promising Results for Treating Complex SFA Disease

Endologix has announced the one-year results of the DETOUR2 Trial, a prospective, single-arm, international, multi-center clinical evaluation of the DETOUR System for treating complex superficial femoral artery (SFA) disease. The study demonstrated the system's efficacy with low complication rates, deep venous thrombosis (DVT), and clinically-driven target lesion revascularization (CD-TLR), while achieving excellent one-year primary patency.

The DETOUR2 Study enrolled 202 patients at 32 sites, with 200 patients treated using the DETOUR system. The mean lesion length was 32.7 cm, with 96% being chronic total occlusions (CTO) and 70% severely calcified. Despite these challenging lesion characteristics, the trial yielded impressive results at the one-year mark.

Why this matters: The successful treatment of complex SFA disease using the DETOUR System has the potential to improve the quality of life for millions of people worldwide who suffer from peripheral artery disease. This minimally invasive approach could also reduce healthcare costs associated with prolonged hospitalization and open surgical bypass.

Freedom from CD-TLR was 87.7% through 1 year, while patency, defined as freedom from occlusion, was 92.4% through 12 months. Clinical success, defined as improvement in at least one Rutherford Category at 12 months, was achieved in 97.2% of patients. The study also reported a low 30-day major procedure-related infection rate of 0.5% and freedom from major adverse events (MAEs) at 30 days of 93%.

The 12-month incidence of symptomatic DVT was 4.1%, with no pulmonary emboli reported. Patients treated with the DETOUR System had an average hospital stay of just 1.1 days, highlighting the minimally invasive nature of the procedure and its potential to reduce healthcare costs associated with prolonged hospitalization.

Matt Thompson, MD, President, and CEO of Endologix, commented on the trial results, stating, "The publication of the one-year results confirms the DETOUR System's clinical promise in treating long femoropopliteal lesions. As we launch this therapy, we are committed to an extensive training and education program that ensures the best patient outcomes."

The DETOUR System offers a novel approach to treating complex peripheral artery disease (PAD) by enabling physicians to 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 approach is particularly effective for patients with long lesions (20cm-46cm in length), those who have already undergone failed endovascular procedures, or those who may be sub-optimal candidates for open surgical bypass.

Endologix LLC, the California-based global medical device company behind the DETOUR System, is dedicated to improving patients' lives by providing innovative therapies for the interventional treatment of vascular disease. The company's therapeutic portfolio includes a variety of products in various stages of development designed to address clinically relevant unmet needs in the treatment of vascular diseases.

The one-year results of the DETOUR2 Trial demonstrate the DETOUR System's potential to revolutionize the treatment of complex SFA disease, offering patients with challenging lesions a minimally invasive alternative to traditional open surgical bypass. As Endologix moves forward with the commercial launch of this innovative therapy, the company remains committed to providing comprehensive training and education to ensure optimal patient outcomes and further advance the field of endovascular interventions.

Key Takeaways

  • DETOUR2 Trial shows 92.4% patency and 87.7% freedom from CD-TLR at 1 year.
  • Low complication rates: 0.5% major procedure-related infection, 4.1% symptomatic DVT.
  • Average hospital stay: 1.1 days, highlighting minimally invasive nature.
  • DETOUR System treats complex SFA disease with low risk of open surgical bypass.
  • Endologix committed to comprehensive training and education for optimal patient outcomes.