Lombard Medical, Inc. presented efficacy and safety data from the three-year follow up of the U.S. PYTHAGORAS pre-marketing approval (PMA) trial of Aorfix, the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations from 0 to 90 degrees. The data was presented at the VEITHsymposium on November 19, 2015. The data, presented by Mark F. Fillinger, M.D., principal investigator of the Aorfix PYTHAGORAS trial, Director of Vascular Surgery Training Programs, and Professor of Surgery at Geisel School of Medicine, Dartmouth, at the VEITHsymposium, showed 100% freedom from Type I & III endoleaks, 92.9% freedom from aneurysm sac expansion and 92.9% freedom from device migration in patients with 60 to 131 degree aortic neck angulations, a group typically considered difficult-to-treat and associated with poor treatment outcomes.

Freedom from all-cause mortality was 78.1% in this group. Results for the patient group with more standard neck anatomy, including neck angulations less than 60 degrees, were equally impressive. Freedom from sac expansion was 93.0% in this group, while freedom from all-cause mortality was 86.6%.

Freedom from device migration was 95.2% for this subset of patients. The PYTHAGORAS study formed the basis of the FDA approval of Aorfix. The controlled, prospective, non-randomized, multi-center study evaluated 218 patients, a majority of whom had neck angles between 60 to 90 degrees.

Lombard anticipates publication of the five-year outcomes in 2016 and continues to collect data on effectiveness and safety for up to five years post-implant.