Five-Year PYTHAGORAS Data Presented for Lombard Medical's Aorfix EVAR System

December 5, 2016—Lombard Medical, Inc. announced that long-term data for its Aorfix endovascular stent graft system were presented on November 17 at the 43rd annual VEITHsymposium in New York, New York. The 5-year data from the United States PYTHAGORAS trial, which was conducted under an investigational device exemption from the US Food and Drug Administration, were presented by Prof. Mahmoud Malas, MD, of Johns Hopkins Bayview Medical Center in Baltimore, Maryland.

The Aorfix system is intended for the endovascular aneurysm repair of abdominal aortic aneurysms. The device is designed for highly tortuous anatomy and holds global approvals to treat abdominal aortic aneurysms with aortic neck angles up to 90º. Aorfix has received European CE Mark approval and Japanese regulatory approval and FDA approval in 2013.

According to the company, PYTHAGORAS studied 218 patients, 151 of whom had neck angles ≥ 60º. Prof. Malas showed that this group of patients had several other characteristics that were predictive of poor outcomes, including a very high percentage of female patients and a higher average age.

Lombard Medical reported that the data provide confirmation of sustained performance in the most challenging anatomies, including high-neck angulation. At 5 years, there were no type I or III endoleaks, migration was seen in 3.3% of cases, freedom from aneurysm-related mortality in patients with neck angles ≥ 60º was 95%, rising to 99% in patients with neck angles < 60º.

In the company's press release, Prof. Malas concluded, “Despite these patients having severely challenging anatomy and multiple other predictors of poorer outcomes, the performance of Aorfix after 5 years of implantation is very similar to that of competitor devices used in normal risk patients. This important long-term data from a unique study into challenging anatomy supports the use of Aorfix in patients with both normal and tortuous anatomy.”

A paper presenting the full data at 5-years follow-up has been accepted for publication by the Journal of Vascular Surgery, advised Lombard Medical.