Endologix Shares Positive 12-Month Results of DETOUR-2 Trial

Endologix LLC is lauding 12-month results of the DETOUR 2 trial, an Investigational Device Exemption (IDE) study designed to evaluate safety and effectiveness of the DETOUR System for percutaneous bypass in treating long-segment femoropopliteal disease. The primary safety endpoint is a composite outcome of major adverse events (MAE) through 30 days, and consists 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.

“We are delighted to present results of the first-ever, fully percutaneous, transmural arterial bypass (PTAB) therapy. PTAB is performed using the DETOUR System, which earned FDA Breakthrough Device Designation, and is comprised of the ENDOCROSS Device and TORUS Stent Graft,” Endologix President/CEO Matt Thompson said. “The presentation of this study represents an important milestone in our effort to bring this novel therapy to market, as we seek U.S. regulatory approval to offer endovascular alternatives to open lower limb bypass for patients with long femoropopliteal occlusions.”
 
The DETOUR 2 clinical trial enrolled 202 U.S. and European patients for the primary analyses. A pre-market approval (PMA) application for the DETOUR Systems was submitted to the U.S. Food and Drug Administration in October 2022. The results are as follows:

• Ninety-six percent 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%.
• The one-year effectiveness endpoint was also met, with 72.1% freedom from CD-TLR and recurrent stenosis > 50% at 12 months. The primary assisted patency was 77.7% at 12 months. The secondary patency at 12 months was 89%.
• There was marked improvement in Quality of Life as measured by the EQ-5D-5L index when comparing pre- and post-treatment scores. Mean index values of 0.69, 0.77, and 0.80, were seen at baseline, 30 days, and 12 months respectively. Mean EQ VAS scores were 62.8, 72.1, and 70.5 over the same periods. 

“This system has potential to introduce a minimally invasive alternative for patients in need of a femoropopliteal bypass. The low MAE rate, coupled with good primary patency provides supportive data for the feasibility of this new technology in a challenging patient population,” said Dr. Sean Lyden, one of the study’s principal investigators and chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute.
 
“DETOUR 2 showed promising results in both safety and efficacy among patients treated with endovascular approach for long complex SFA/POP occlusions including severe calcification, in stent restenosis, and long occlusions. The recently presented data are extremely encouraging. In many patients who may not be candidates for surgical or native endovascular revascularizations, the DETOUR procedure will provide them with a new treatment modality,” said Jihad Mustapha M.D., co-principal investigator for the DETOUR 2 trial, and president/CEO/director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention.
 
Endologix LLC is a Santa Rosa, Calif.-based, global medical device company developing therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes numerous products in various stages of development that 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 Oct. 1, 2020, Endologix became a private company, wholly owned by Deerfield Management, an investment management firm. In April 2021, Endologix completed the acquisition of PQ Bypass Inc., a privately held medical technology, adding the DETOUR System and TORUS Stent Graft to its 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 U.S. law to investigational use.