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Three-Year Follow-Up Data From Lombard Medical Aorfix(TM) PYTHAGORAS Pivotal Trial Presented at 42nd Annual VEITHsymposium(TM)


Lombard Medical, Inc. (NASDAQ: EVAR), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), presented efficacy and safety data from the three-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 from 0 to 90 degrees. The data was presented at the VEITHsymposium™ on November 19, 2015.

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 Type I & III endoleaks, 92.9% freedom from aneurysm sac expansion and 92.9% freedom from device migration in patients with 60 to 131 degree aortic neck angulations, a group typically considered difficult-to-treat and associated with poor treatment outcomes. Freedom from all-cause mortality was 78.1% in this group. Results for the patient group with more standard neck anatomy, including neck angulations less than 60 degrees, were equally impressive. Freedom from sac expansion was 93.0% in this group, while freedom from all-cause mortality was 86.6%. Freedom from device migration was 95.2% for this subset of patients.

Dr. Fillinger commented that because more than 80% of PYTHAGORAS patients had now reached five-year follow-up he was able to present Kaplan-Meier analyses to five years. These indicated 96.5% freedom from AAA-related mortality and 98.0% freedom from sac rupture at the fifth year. Dr. Fillinger showed that the Aorfix Kaplan-Meier data, collected from patients in whom 69% had neck angulation ≥ 60 degrees, was virtually identical to results obtained with competitor stent grafts in patients in whom no aortic necks had an angle greater than 60 degrees (Zwolak, R. M. (2005). Lifeline registry of endovascular aneurysm repair. Journal of Vascular Surgery).

"Aorfix continues to demonstrate long-term clinical durability as reflected by our positive three-year outcomes from our PYTHAGORAS premarketing approval study which continue to reinforce the solid clinical performance and safety of Aorfix in patients with challenging anatomies," continued Lombard CEO Simon Hubbert. "Aorfix is proving to be effective over the long term in treating patients with highly-angulated necks and those more typical AAA anatomies involving patients with angulations below 60 degrees."

The PYTHAGORAS study 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 anticipates publication of the five-year outcomes in 2016 and continues to collect data on effectiveness and safety for up to five years post-implant.

Posted-In: News FDA Press Releases


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