Lombard Medical showcases Aorfix Endovascular Stent Graft at SVS Annual Meeting

Lombard Medical, Inc.Jun 6 2014

Lombard Medical, Inc. (Nasdaq: EVAR), a medical device company focused on Endovascular Aortic Repair (EVAR) of abdominal aortic aneurysms (AAA), showcased its Aorfix™ Endovascular Stent Graft at the 2014 Society for Vascular Surgery (SVS) Annual Meeting in Boston, June 5-7.

Mark Fillinger, M.D., Director, Vascular Surgery Training Programs, Professor of Surgery, Geisel School of Medicine, Dartmouth, will present "Clinical Experience Treating Highly Angulated AAAs On-Label Using the Aorfix Endovascular Stent Graft" at the SVS Vascular Live symposium today. Dr. Fillinger, who was Principal Investigator for the randomized, controlled PYTHAGORAS trial, stated, "Aorfix's highly conformable design allows for the treatment of a wide range of AAA anatomies. The PYTHAGORAS trial was unique and challenging in its focus on anatomy that has never been studied before in an FDA trial, yet Aorfix delivered results very similar to competitor devices used in much less challenging cases."

Additionally, Lombard showcased Aorfix at the meeting with state-of-the art simulation tools to demonstrate the technical and clinical benefits of the stent graft in various case scenarios with complex anatomies.

CEO Simon Hubbert stated, "Aorfix provides a safe, effective, and FDA-approved solution for patients with challenging aortic neck anatomies, representing a significant advancement in the treatment of AAA. We are pleased that the physician community continues to be receptive to Aorfix, and we look forward to working with key centers to expand our presence in the United States."

Lombard completed the PYTHAGORAS Investigational Device Exemption (IDE) study in September, 2009, which enrolled 210 patients across 41 U.S. medical centers, as well as three in Canada and one in Poland. In February 2013, the company received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) to market the Aorfix Endovascular Stent Graft for treatment of patients with aortic neck angulations between 0-90 degrees.