The DETOUR 2 study is a prospective, single-arm, international, multi-center clinical evaluation of the novel DETOURTM System for fully percutaneous femoropopliteal bypass procedures.
IRVINE, Calif. June 15, 2023— Endologix LLC, a privately held, global medical device company, dedicated to providing disruptive therapies for the interventional treatment of vascular disease, today announced the 24-month results of the DETOUR2 Study. Percutaneous Transmural Arterial Bypass (PTAB) with the DETOUR™ System, recently received PMA Approval from the FDA on June 7, 2023. This system offers a unique approach to treating complex peripheral arterial disease (PAD), enabling physicians to percutaneously bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein to restore blood flow to the leg. The DETOUR System is comprised of the ENDOCROSSTM device and TORUSTM stent grafts.
The DETOUR2 Study enrolled 202 patients in the United States and Europe. The 24-month results from the study were presented at 2023 Annual Meeting of the Society of Vascular Surgery by one of the study’s principal investigators, Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute.
The results* presented included:
- Ninety-six percent (96%) of enrolled patients had chronic total occlusions, with a mean lesion length of 32.7cm.
- Technical success was achieved in 100% of treated patients and the primary safety endpoint was surpassed with a 30-day MAE rate of 7.0%
- The freedom from CD-TLR at 24 months was 76.7%, and secondary patency was 82.3%.
- The freedom from symptomatic DVT was 96.5% at 24 months.
- The freedom from major lower limb amputation was 98.5% at 24 months.
“The two-year results from the DETOUR2 Study are encouraging and demonstrate PTAB using the DETOUR System offers good patency rates in long SFA lesions. As noted in the conclusion of the presentation, the two-year data mimics those of surgical bypass without the need for general anesthesia, long length of stay, and high risk of complications. We look forward to continuing to study the DETOUR System,” said Dr. Lyden.
“We are delighted to present the two-year results of the DETOUR2 Study which investigates the use of the PTAB therapy in patients with very long SFA lesions” said Professor Matt Thompson, MD, President and CEO of Endologix. “The results suggest that the DETOUR System offers a viable approach in patients where open surgery is the currently recommended treatment. We are excited to see more patients benefit from this unique approach to the treatment of complex PAD.”
*Lyden et al. Durability of Percutaneous Bypass for Treatment of Femoropopliteal Disease: Two-year Outcomes of the DETOUR-2 Study. VAM 2023
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. Endologix is 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 TOR.US Stent Graft to the Company’s product pipeline.
The company has offices and manufacturing sites in Irvine, Milpitas and Santa Rosa, California. To learn more about Endologix, please visit https://endologix.com/.
INDICATIONS FOR USE:
The DETOUR™ System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200mm to 460mm in length with chronic total occlusions (100mm to 425mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR™ System, or any of its components, is not for use in the coronary and cerebral vasculature.
The DETOUR™ System is contraindicated in patients with:
- A distal common femoral artery (CFA) <7 mm in diameter.
- Increased risk of deep vein thrombosis (DVT), such as patients with a recent history of DVT, thrombophilia, and disseminated malignancy.
- Untreated flow-limiting aortoiliac occlusive disease.
- Lack of patent single vessel tibial runoff to ankle.
- Known coagulopathy, bleeding diathesis, or thrombocytopenia that cannot be medically managed.
- Known hypersensitivities, allergies or contraindications to: Nitinol; PTFE; aspirin; heparin; antiplatelet; anticoagulant or thrombolytic therapy; or contrast media that cannot otherwise be medically managed.
Refer to Instructions for Use for more information concerning Indications, Contraindications, Specific Anatomic Considerations, Warnings, Precautions, and Adverse Events.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
NOTE: Not all product components are available in every country. Please consult with your Endologix representative to confirm product availability.
©2023 Endologix LLC. All rights reserved. Endologix® is a registered trademark of Endologix LLC in the United States, Europe and Japan. All other trademarks are the property of their respective owners.