Endologix, a California-based medical device company, has announced positive 36-month results from the DETOUR2 Study of the DETOUR System for the treatment of complex peripheral arterial disease (PAD).
The DETOUR System is designed to enable physicians to bypass lesions in the superficial femoral artery using stents routed through the femoral vein to restore blood flow to the leg.
The system includes the ENDOCROSS device and TORUS stent grafts.
This approach is intended for patients with long lesions ranging from 20cm to 46cm, those who have experienced failed endovascular procedures, or patients who are considered sub-optimal candidates for open surgical bypass.
In June 2023, Endologix received approval from the US Food and Drug Administration (FDA) for the DETOUR System to treat complex PAD.
DETOUR2 Study is a prospective, single-arm, international, multi-centre clinical evaluation. It enrolled 202 patients across 32 sites, with 200 patients treated using the DETOUR System for fully percutaneous femoropopliteal bypass procedures.
The findings showed that the system’s efficacy is comparable to open bypass surgery with synthetic grafts.
Additionally, the system demonstrated a favourable safety profile with low complication and deep vein thrombosis (DVT) rates.
The trial found that freedom from clinically driven-target lesion revascularisation (CD-TLR) was 66.8% at three years, and primary patency was 58.2% at 36 months.
Clinical success, defined as improvement in at least one Rutherford Category, was achieved in 96.7% of patients at 36 months.
Freedom from symptomatic deep vein thrombosis (DVT) was 95.9% at three years, and the freedom from major lower limb amputation was 98.5% at 36 months.
Additionally, the average length of hospital stay was 1.1 days.
In May this year, the medical device company announced positive one-year results from the DETOUR2 study.
Endologix president and CEO Matt Thompson said: “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.”
Endologix, which is wholly owned by Deerfield Management, develops therapies for vascular diseases. Its portfolio includes products like the AFX2 Endovascular AAA System, ALTO Abdominal Stent Graft System, and DETOUR System, addressing unmet needs in vascular disease treatment.
