Disruptive Endovascular Solution Offers Minimally Invasive Alternative for Femoropopliteal Bypass Procedure

Currently, the "gold standard" treatment for patients with long blockages in the superficial femoral artery (SFA) is the invasive open femoropopliteal bypass. Endovascular techniques employed for these blockages often have high complication rates. Now, a new system offers patients an alternative treatment method, combining the advantages of both open and endovascular procedures.

The DETOUR System, developed by Endologix LLC (Irvine, CA, USA), enables Percutaneous Transmural Arterial Bypass (PTAB), a unique therapy that delivers a fully percutaneous femoropopliteal bypass through the femoral vein. Designed to treat patients with moderate to severe peripheral arterial disease and long SFA blockages, the DETOUR System employs the ENDOCROSS Device and TORUS Stent Graft.

The DETOUR2 Investigational Device Exemption (IDE) study showcased a 12-month primary patency rate of 72.1% in SFA lesions with an average length of 32.7cm. Notably, the trial achieved a 100% technical success rate in 202 patients, along with a 30-day Major Adverse Event Rate of 7%. This composite outcome includes death, CD-TLR, target limb amputation, symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), and the requirement for transfusion of packed red blood cells (PBRC) during the index procedure. The average hospital stay was just 1.1 days. The DETOUR System, currently an investigational device that has received FDA Breakthrough Device Designation, was recognized as the "Medical Device Engineering Breakthrough" winner at the 7th annual MedTech Breakthrough Awards.

“This award from MedTech Breakthrough is another strong validation of our strategy to expand our product portfolio into the large peripheral vascular market opportunity. Patients with long SFA blockages face tradeoffs with current treatment options. We know that open surgery of any kind is associated with complications that can negatively affect patient quality-of-life,” said Matt Thompson, MD, President and CEO of Endologix. “What makes PTAB with the DETOUR System truly unique is that, as demonstrated in our IDE study's 12-month results, it offers a minimally invasive therapy with comparable patency to open surgery while avoiding many of the complications associated with more invasive procedures. Once approved, the DETOUR System will offer a fully percutaneous femoropopliteal bypass and will provide a disruptive, innovative therapy for the treatment of long-segment SFA disease, thereby expanding the treatment options available for these patients.”

“While open surgery is still technically the gold standard for long-term durability, the reality is that not every patient is a candidate for that procedure and it can carry more risk for the patient,” said James Johnson, managing director, MedTech Breakthrough. “The DETOUR System has the potential to introduce a minimally invasive alternative for patients in need of a femoropopliteal bypass. The breakthrough solution may offer the best of both worlds: a durable, minimally invasive endovascular solution with the patency of open femoropopliteal bypass. The low MAE rate, coupled with good primary patency, provides supportive evidence for the feasibility of this new technology in a challenging patient population. Congratulations to the Endologix team on being for our 2023 ‘Medical Device Engineering Breakthrough’ award.”

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Endologix LLC