The DETOUR procedure: no more need for conventional bypass surgery?

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Devices

Background:

• Long segment occlusive disease of the superficial femoral artery presents a significant treatment challenge.
• Current open surgical and endovascular methods have limitations for these complex cases.
• The DETOUR System represents a novel approach for percutaneous femoro-popliteal bypass.

Purpose of the Study:

• To evaluate the initial clinical outcomes of the DETOUR System for percutaneous femoro-popliteal bypass.
• To assess the safety and efficacy of this new bypass technique in patients with long superficial femoral artery occlusions.
• To report findings from first-in-human and early trial data.

Main Methods:

• A prospective clinical study involving five patients treated with the DETOUR System.
• The DETOUR System was used to create a stent graft bypass from the superficial femoral artery through the femoral vein to the popliteal artery.
• Patients underwent planned 2-year follow-up, including clinical assessment and patency evaluation.

Main Results:

• Successful stent graft implantation in all five patients (100%) using an 8F delivery system.
• No major adverse events (death, bleeding, DVT, revascularization, amputation) within 30 days post-procedure.
• At 24 months, primary patency was 80% and primary assisted patency was 100%.
• Significant improvements in ankle-brachial index and Rutherford class were observed.
• No damage to venous function was reported.

Conclusions:

• The DETOUR System demonstrates safety and favorable clinical outcomes for properly selected patients with long-segment occlusive disease above the knee.
• Percutaneous bypass using the DETOUR System shows promise for treating long femoral lesions.
• Further clinical investigation is warranted to establish the role of this approach.