The findings indicated that the system offers a durable solution for PAD with a low incidence of complications and deep venous thrombosis (DVT). Credit: Rabizo Anatolii / Shutterstock.

Endologix has reported the 36-month outcomes of a study that evaluated its DETOUR System for treating complex peripheral arterial disease (PAD).

The DETOUR 2 Study results were presented at the VIVA Late-Breaking Clinical Trial session on 5 November, underscoring the system’s comparable efficacy to traditional open bypass procedures and its favourable safety profile.

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It included 202 patients across 32 sites, of which 200 received treatment with the DETOUR System.

The mean lesion length treated was reported to be 32.7cm, with a majority being chronic total occlusions (CTO) and severely calcified.

The international, multi-centre clinical evaluation trial has provided significant insights into the DETOUR System by Endologix for fully percutaneous femoropopliteal bypass procedures.

This system utilises the ENDOCROSS device and TORUS stent grafts to enable physicians to bypass lesions in the superficial femoral artery through minimally invasive techniques. 

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The findings indicated that the system offers a durable solution for PAD with a low incidence of complications and deep venous thrombosis (DVT).

Endologix president and CEO Matt Thompson said: “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.”

Key outcomes from the study showcased a freedom from CD-TLR rate of 66.8% over three years and a primary patency rate of 58.2% at 36 months.

Clinical success was achieved in 96.7% of patients at 36 months.

Additionally, patients experienced a high rate of freedom from symptomatic DVT (95.9%) and major lower limb amputation (98.5%) over the same period.

The average hospital stay post-procedure was notably brief at just 1.1 days.

In June 2023, Endologix announced 24-month results from the trial of its system for fully percutaneous femoropopliteal bypass procedures.