Endologix has announced in a press release that the US Food and Drug Administration (FDA) has granted approval for the Detour System to treat patients with complex peripheral arterial disease (PAD).
Patients with long blockages of the superficial femoral artery (SFA) have had limited treatment options. The recommended therapy is open surgical bypass, which is invasive, has a high early complication rate, and requires prolonged recovery. Endovascular treatments are feasible in selected patients but have limited patency.
Percutaneous transmural arterial bypass (PTAB) with the Detour System offers a novel approach to treating complex PAD, enabling physicians to bypass lesions in the SFA by using stents routed through the femoral vein to restore blood flow to the leg. This approach is particularly effective for patients with long lesions (20–46cm in length), those that have already undergone failed endovascular procedures, or those that may be suboptimal candidates for open surgical bypass.
“We are delighted to receive [US] FDA approval of the DETOUR System,” said Matt Thompson, president, and CEO of Endologix. “PTAB therapy represents a significant step forward for patients with complex PAD. They have long needed a more effective and less invasive treatment option for long lesions of the SFA. We are proud to be pioneering this novel approach and continuing to innovate on behalf of patients. We look forward to launching this new therapy in the US through a targeted market release in the coming weeks.”