Endologix Wins “Medical Device Engineering Breakthrough” Award in 7th Annual MedTech Breakthrough Awards Program

Percutaneous Transmural Arterial Bypass (PTAB) with the DETOUR System is a unique therapy that provides a fully percutaneous femoropopliteal bypass that is routed through the femoral vein. The DETOUR System, currently an investigational device with FDA Breakthrough Device Designation, uses the ENDOCROSS™ Device and TORUS™ Stent Graft and is designed to treat patients with moderate to severe peripheral arterial disease with long blockages of the superficial femoral artery (SFA).

The current “gold standard” for treating patients with long SFA blockages is open femoropopliteal bypass, which is an invasive procedure. Endovascular techniques used for these long blockages have high rates of complications. The DETOUR System may provide patients with a new treatment modality, combining the best aspects of both open and endovascular procedures.

The DETOUR2 Investigational Device Exemption (IDE) study reported* a 12-month primary patency of 72.1% in SFA lesions with a mean length of 32.7cm. Importantly, the trial demonstrated technical success of 100% in 202 patients with a 30-day Major Adverse Event Rate of 7%, a composite outcome consisting of death, CD-TLR, amputation of the target limb, symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), and the need for transfusion of packed red blood cells (PBRC) at the index procedure. The average length of the hospital stay was only 1.1 days.

“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.”

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Telehealth, Clinical Administration, Patient Engagement, Electronic Health Records (EHR), Virtual Care, Medical Devices, Medical Data and many more. This year’s program attracted more than 4,000 nominations from over 17 different countries throughout the world.

“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.”

*Lyden. Percutaneous Bypass for Treatment of Long-Segment Femoropopliteal Disease: 12 Month Results from the DETOUR 2 Trial Volume 75, Issue 6, E337-E338, June 2022

About Endologix

Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have clinically relevant unmet needs. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR products include the AFX®2 Endovascular AAA System and the ALTO® Abdominal Stent Graft System. On October 1, 2020, Endologix became a private company, wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. In April 2021, Endologix completed the acquisition of PQ Bypass, Inc., a privately held medical technology company, adding the DETOUR System and TORUS Stent Graft to the Company’s product pipeline. The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body. The DETOUR System is an investigational device, limited by United States law to investigational use.

The company has offices and manufacturing sites in Irvine and Santa Rosa, California. To learn more about Endologix, please visit https://www.endologix.com/.

About MedTech Breakthrough

Part of Tech Breakthrough, a leading market intelligence and recognition platform for global technology innovation and leadership, the MedTech Breakthrough Awards program is devoted to honoring excellence and innovation in medical & health technology companies, products, services and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough healthcare and medical companies and products in categories that include Patient Experience & Engagement, Health & Fitness, Medical Devices, Clinical Administration, Connected Healthcare, Medical Data, Healthcare Cybersecurity and more. For more information, visit MedTechBreakthrough.com.