Endologix LLC announced the 12-month results of the DETOUR 2 trial during a late-breaking clinical trial session at the 2022 VIVA Vascular InterVentional Advances (VIVA) Conference in Las Vegas, Nevada. DETOUR 2 is an Investigational Device Exemption (IDE) study, designed to evaluate safety and effectiveness of the DETOUR System for percutaneous bypass in the treatment of 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.

The DETOUR 2 clinical trial has enrolled 202 patients in the United States and Europe for the primary analyses. A Pre-Market Approval (PMA) Application for the DETOUR Systems was submitted to the FDA in October 2022. The 12-month results from the study were presented at 2022 VIVA Conference 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 are listed below: 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 1-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.