Lombard Medical presents positive data from PYTHAGORAS PMA trial of Aorfix at VEITHsymposium

Positive Outcomes in Abdominal Aortic Aneurysm Patients with Challenging Anatomies Reinforce Clinical Value of Aorfix

Lombard Medical, Inc. (NASDAQ: EVAR), a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), today presented efficacy and safety data from the two-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 up to 90 degrees.

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 aneurysm rupture, 98% freedom from Type I & III endoleaks and 99% freedom from device migration in patients with a 60 to 90 degree aortic neck angulation, a group typically considered difficult-to-treat and associated with poor treatment outcomes. The VEITHsymposium is being held at the New York Hilton-Midtown in New York City on November 18th – 22nd.

Other key findings from the two-year data included 98.2% freedom from AAA-related mortality and 97.2% freedom from graft occlusion in patients with neck angles between 60 to 90 degrees. Lombard Medical also presented results evaluating the use of Aorfix in patients with tortuous iliac anatomy who may be at increased risk of iliac limb occlusion and other complications, which are commonly caused by kinking, migration or dislocation of a stent graft, or extension of the graft into the external iliac artery. The data, presented by Dr. Brian R. Hopkinson, co-inventor of Aorfix and Emeritus Professor of Vascular Surgery at University of Nottingham and Consultant Vascular Surgeon at Queen’s Medical Centre, U.K., found that despite distinct changes in iliac angulation resulting from aneurysm regression (reversal) after EVAR, the incidence of iliac-related complications did not increase and remained low.

“We’re pleased to present positive two-year outcomes from our PYTHAGORAS premarketing approval study which reinforce the solid clinical performance and safety of Aorfix in patients with challenging anatomies,” said Simon Hubbert, CEO of Lombard Medical. “Aorfix is uniquely designed to treat patients with highly-angulated necks and yield consistently positive treatment outcomes in both challenging and more typical cases involving patients with angulations below 60 degrees.”

Both data analyses were derived from the PYTHAGORAS study, which 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 Medical anticipates publication of the two-year outcomes in 2015, and will continue to collect data on effectiveness and safety for up to five years post-implant.