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FDA Approves Endologix's DETOUR™ System for Treating Long Complex Superficial Femoropopliteal Lesions in Patients with PAD

Friday, June 09, 2023

Endologix, a privately held global medical device company, has received FDA approval for its DETOUR System to treat complex peripheral arterial disease (PAD). PAD affects over 8.5 million Americans and can lead to pain, reduced mobility, and amputation. Patients with long blockages in the superficial femoral artery (SFA) currently have limited treatment options, such as invasive surgical bypass with high complication rates and lengthy recovery periods. Endovascular treatments also have limitations in these cases.

The DETOUR System introduces a new approach called Percutaneous Transmural Arterial Bypass (PTAB) for treating complex PAD. It enables physicians to bypass SFA lesions by using stents routed through the femoral vein, restoring blood flow to the leg. This method is particularly beneficial for patients with long lesions (20cm-46cm), those who have undergone unsuccessful endovascular procedures, or those who are not suitable candidates for open surgical bypass.

Dr. Matt Thompson, President and CEO of Endologix, expressed satisfaction with the FDA approval of the DETOUR System. He emphasized that PTAB therapy is a significant advancement for patients with complex PAD, offering a more effective and less invasive treatment option for long SFA lesions. Endologix plans to launch this therapy in the United States through a targeted market release in the coming weeks.

Endologix is committed to improving patient outcomes and has a track record of introducing innovative vascular therapies. The DETOUR System represents a breakthrough in PAD treatment, addressing the critical clinical needs of patients.


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