Endologix LLC announced that the ELEVATE (Expanding Patient Applicability with Polymer Sealing Ovation ALTO Stent Graft) IDE Study has been published online in the Journal of Vascular Surgery. The study reports the clinical outcomes of the ALTO Abdominal Stent Graft System and highlights the device's safety and effectiveness at one-year post-procedure. Additionally, the results will be presented by the study's principal investigator, Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic, at the VEITHsymposium in November 2022.

The ELEVATE study enrolled 75 patients between March 2017 and February 2018 in 16 centers in the United States. The study included patients with infrarenal AAAs with neck diameters of 16-30mm at 7mm below the lowest renal artery. Patients were followed for 30 days, 6 months, and 1 year by clinical evaluation, CT, and abdominal x-ray imaging.

The study concluded that the Endologix ALTO stent graft is safe and effective in treating AAA with appropriate anatomy at one year. The results presented included: Treatment success rate of 96.7% at 12 months; All-cause mortality of 4.0% at 12 months; no AAA-related mortality occurred; Major adverse event rate of 5.3% at 30 days. Data from the ELEVATE Study was utilized in a PMA-Supplement to the FDA in 2019.

Subsequent approval of the ALTO Abdominal Stent Graft System and commercialization occurred in 2020.