IRVINE, Calif.--(BUSINESS WIRE)--Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, has announced the online publication of the one-year results of the DETOUR2 Trial in the Journal of Vascular Surgery ( JVS1). The study demonstrated that the DETOUR System offers a viable endovascular option for patients with long segment, complex superficial femoral artery (SFA) disease. Percutaneous Transmural Arterial Bypass (PTAB) with the DETOUR System offers a novel approach to bypass the SFA using the vein as a conduit. The study highlighted low rates of complications, deep venous thrombosis (DVT), and clinically-driven target lesion revascularization (CD-TLR), and excellent one-year primary patency.
"The publication of the one-year results confirms the DETOUR System's clinical promise in treating long femoropopliteal lesions," said Matt Thompson, MD, President, and CEO of Endologix. "As we launch this therapy, we are committed to an extensive training and education program that ensures the best patient outcomes. Consistent with our evidence-based approach, further data on the performance of the DETOUR system in real-world use will be defined in the PTAB-1 post market study."
The DETOUR2 Study enrolled 202 patients at 32 sites, and 200 patients were treated with the DETOUR system. The mean lesion length was 32.7 cm, 96% were chronic total occlusions (CTO), and 70% were severely calcified.
The results presented highlight:
- Freedom from CD-TLR was 87.7% through 1 year.
- Expressed as a binary end point, patency (defined as freedom from occlusion), was 92.4% through 12 months.
- Clinical success, defined as improvement in at least one Rutherford Category at 12 months, was 97.2%.
- Major procedure related infection within 30 days after the index procedure was 0.5%.
- Freedom from major adverse events (MAEs) at 30 days was 93%.
- The 12-month incidence of symptomatic DVT was 4.1% with no pulmonary emboli reported.
- Average length of hospital stay was 1.1 days.
1 Lyden SP, Soukas PA, De A, et al. DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease. J Vasc Surg. Published online February 15, 2024. doi:10.1016/j.jvs.2024.02.004
About the DETOUR System
PTAB with the DETOUR System offers a novel approach to treating complex PAD, enabling physicians to bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein via a transmural passage, to restore blood flow to the leg. This approach is effective for patients with long lesions (20cm-46cm in length), those that have already undergone failed endovascular procedures, or those that may be sub-optimal candidates for open surgical bypass.
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. Endologix’s commercial products, including the AFX®2 Endovascular AAA System, ALTO® Abdominal Stent Graft System, and the DETOUR™ System, are designed to treat a range of vascular diseases, from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix is wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. The company has offices and manufacturing sites in Irvine, Milpitas and Santa Rosa, California. To learn more about Endologix, please visit https://www.endologix.com/.
