Roll-In Data From Lombard Medical's PYTHAGORAS AAA Trial Presented

February 24, 2012—Data from the roll-in phase of the PYTHAGORAS trial evaluating abdominal aortic aneurysm (AAA) repair using the Aorfix endovascular stent graft (Lombard Medical Technologies, Inc., Tempe, AZ) were presented at the VEITH Symposium in New York City in November and at the International Symposium on Endovascular Therapy in Miami Beach in January.

Thirty-day and 1-year follow-up data from the roll-in phase demonstrated no cases of the graft failing to seal against the artery wall; no cases of graft leakage, migration, or fracture; and, in all cases, the aneurysm sac decreased in diameter or remained stable after implantation of the Aorfix. The data were presented by Mark Fillinger, MD, at VEITH and William Gray, MD, at ISET.

According to Lombard Medical, PYTHAGORAS is the largest prospective, controlled study to include patients with highly tortuous aortic and iliac anatomies. The trial was designed to show the potential of Aorfix to treat both standard and difficult-to-treat AAA cases and consisted of two groups. The roll-in group included 62 patients with aortic neck angles < 60°, and the study group consisted of 150 cases with aortic neck angles ≥ 60°. 

Dr. Fillinger served as Principal Investigator of PYTHAGORAS. In a company press release, he commented, “The Aorfix device has given excellent results in patients with typical anatomy, based on prospective independent monitoring. Although neck angles were < 60° in all ‘roll-in' patients, 65% were > 45°, which is already at a challenging level.”

Dr. Gray added, "Clinical practice is increasingly moving toward endovascular aneurysm repair and away from surgery, and devices that both perform well and are flexible, such as Aorfix, will play an important role as a highly effective option for patients with more complex anatomy and increase the number of patients for whom a nonoperative AAA repair is possible."