IRVINE, Calif.– Endologix LLC, a privately held global medical device company dedicated to improving patients’ lives by providing disruptive therapies for the interventional treatment of vascular disease, 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.
“The publication of results of the ELEVATE Study represent a foundational block of the evidence that we are building for our ALTO product line,” said Matt Thompson, MD, President and CEO of Endologix. “To further expand this evidence base, we have recently begun enrolling patients in the JAGUAR randomized controlled trial, which is a randomized comparative study examining the hypothesis that the ALTO endograft will have superior durability to competitive endografts secondary to a significant reduction in post-EVAR aortic neck dilatation. We believe that ALTO plays a significant role in the management of AAA based on its durability, low-profile, and broadest patient applicability within EVAR.”
Reference
Sean P. Lyden, D. Christopher Metzger, Steve Henao, Sonya Noor, Andrew Barleben, John P. Henretta, Levester Kirksey, One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial, Journal of Vascular Surgery, (2022), ISSN 0741-5214.
