Endologix LLC, a global medical device company focused on innovative therapies for vascular disease treatment, has announced the final 36-month results of its DETOUR2 Study. The DETOUR System offers a unique approach to treating complex peripheral arterial disease (PAD) by enabling physicians to perform a percutaneous bypass of lesions in the superficial femoral artery.

This is achieved using stents that are routed through the femoral vein, restoring blood flow to the leg. The DETOUR System consists of the ENDOCROSS device and TORUS stent grafts.

The results from the 36-month follow-up of the study show that the DETOUR System's effectiveness is comparable to open bypass surgery with a synthetic graft. The study also highlights the system’s low complication rates, including a notably low incidence of deep venous thrombosis (DVT), reinforcing the system’s favourable safety profile.

The DETOUR2 Study involved 202 patients across 32 clinical sites, with 200 patients receiving the treatment. The study focused on patients with long segment superficial femoral artery (SFA) disease, where the average lesion length was 32.7 cm, 96% of cases were chronic total occlusions (CTO), and 70% were severely calcified.

Key findings from the study include:

• 66.8% freedom from clinically driven target lesion revascularisation (CD-TLR) after three years.
• 58.2% primary patency rate at 36 months.
• 96.7% clinical success, defined as improvement in at least one Rutherford Category at 36 months.
• 95.9% freedom from symptomatic DVT at 36 months.
• 98.5% freedom from major lower limb amputation at 36 months.
• Average hospital stay of 1.1 days.

These results underscore the potential of the DETOUR System as a less invasive, effective alternative to open surgery for patients with challenging femoropopliteal lesions.

Endologix remains committed to achieving optimal patient outcomes through continued training, data collection, and the PTAB-1 post-market study, which will further validate these findings in real-world settings.

 

 

 

Source: endologix.com

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