Two-Year PYTHAGORAS Data Presented for Lombard Medical's Aorfix Device

November 20, 2014—Lombard Medical, Inc. announced the presentation of safety and efficacy data from the 2-year follow-up in the United States PYTHAGORAS premarketing approval trial of the Aorfix endovascular stent graft for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA).

Mark F. Fillinger, MD, principal investigator of the Aorfix PYTHAGORAS trial presented the data at the 41^st VEITHsymposium, held November 18–22, 2014, in New York, New York. Dr. Fillinger is Director of Vascular Surgery Training Programs, and Professor of Surgery at Geisel School of Medicine, Dartmouth College.

PYTHAGORAS formed the basis of the US Food and Drug Administration approval of Aorfix, which was announced in February 2013. The controlled, prospective, nonrandomized, multicenter PYTHAGORAS study evaluated 218 patients, a majority of whom had neck angles between 60º and 90º.

Dr. Fillinger presented data showing 100% freedom from aneurysm rupture, 98% freedom from type I and III endoleaks, and 99% freedom from device migration in patients with a 60–90º aortic neck angulation—a patient group typically considered difficult-to-treat and associated with poor treatment outcomes.

Other key findings from the 2-year data included 98.2% freedom from AAA-related mortality and 97.2% freedom from graft occlusion in patients with neck angles of 60–90º.

Lombard Medical also announced that Brian R. Hopkinson, MD, who is co-inventor of Aorfix, presented results evaluating the use of the device in patients with tortuous iliac anatomy who may be at increased risk of iliac limb occlusion and other complications that are commonly caused by kinking, migration, or dislocation of a stent graft or extension of the graft into the external iliac artery.

The findings showed that despite distinct changes in iliac angulation resulting from aneurysm regression after EVAR, the incidence of iliac-related complications did not increase and remained low. Dr. Hopkinson is Emeritus Professor of Vascular Surgery at University of Nottingham and Consultant Vascular Surgeon at Queen’s Medical Centre in Nottingham, United Kingdom.

According to Lombard Medical, both data analyses were derived from the PYTHAGORAS study. The company advised that it anticipates publication of the 2-year outcomes in 2015, and will continue to collect data on effectiveness and safety for up to 5 years postimplantation.

The Aorfix AAA device has global approvals for the treatment of patients with aortic neck angulations up to 90º. The device is available in more than 20 countries around the world, including the United States, the United Kingdom, Germany, and Japan.

The Aorfix is intended for treatment of infrarenal aortic and aortoiliac aneurysms. When placed within the aneurysm, Aorfix creates an internal bypass of the aneurysm to reduce the risk of rupture. The Aorfix device features a helical and circular design that allows it to conform to the natural contours of human anatomy, including aortic necks with high angulations and iliac arteries with extreme bends, stated Lombard Medical.