Three-Year Data Presented From PYTHAGORAS Pivotal Trial of Lombard Medical's Aorfix

November 30, 2015—Lombard Medical, Inc. announced that efficacy and safety data from the 3-year follow-up of the United States PYTHAGORAS premarketing approval (PMA) trial were presented by Principal Investigator Mark F. Fillinger, MD, at the VEITHsymposium, which was held November 17–21 in New York, New York. Dr. Fillinger is Director of Vascular Surgery Training Programs and professor of surgery at Geisel School of Medicine at Dartmouth College in Hanover, New Hampshire.

PYTHAGORAS is studying the company’s Aorfix endovascular stent graft for the treatment of abdominal aortic aneurysms (AAA). The device has global approvals for the treatment of patients with aortic neck angulations from 0º to 90º.

According to the company, the data showed 100% freedom from type 1 and 3 endoleaks, 92.9% freedom from aneurysm sac expansion, and 92.9% freedom from device migration in patients with aortic neck angulations of 60º to 131º—a group of patients typically considered difficult-to-treat and associated with poor treatment outcomes. Freedom from all-cause mortality was 78.1% in this group.

The company noted that results for the patient group with more standard neck anatomy, including neck angulations < 60º, were equally impressive. Freedom from sac expansion was 93% in this group, and freedom from all-cause mortality was 86.6%. Freedom from device migration was 95.2% for this subset of patients.

In Lombard Medical’s press release, Dr. Fillinger advised that 5-year follow-up data are available for more than 80% of PYTHAGORAS patients. He presented Kaplan-Meier analyses for 5 years that indicated 96.5% freedom from AAA-related mortality and 98% freedom from sac rupture.

The Aorfix Kaplan-Meier data, collected from patients in whom 69% had neck angulation ≥ 60º, were virtually identical to results obtained with competitor stent grafts in patients in whom no aortic necks had an angle > 60º.

Lombard Medical stated that the PYTHAGORAS study formed the basis of the FDA approval of Aorfix. The controlled, prospective, nonrandomized, multicenter study evaluated 218 patients, a majority of whom had neck angles between 60º and 90º. Lombard anticipates publication of the 5-year outcomes in 2016 and continues to collect data on effectiveness and safety for up to 5-years postimplant.