US-based Lombard Medical has showcased its Aorfix endovascular stent graft at the 2014 Society for Vascular Surgery (SVS) annual meeting in Boston.
The Aorfix endovascular stent graft was specifically designed to solve the problems that exist in treating complex tortuous anatomy, which is often present in advanced abdominal aortic aneurysms (AAA) disease.
Dr Mark Fillinger, principal investigator for the Pythagoras trial, will present ‘Clinical Experience Treating Highly Angulated AAAs On-Label Using the Aorfix Endovascular Stent Graft’ at the SVS Vascular Live symposium.
Lombard Medical has also showcased Aorfix with simulation tools to demonstrate the technical and clinical benefits of the stent graft in various case scenarios with complex anatomies.
Lombard Medical CEO Simon Hubbert said that 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 US," Hubbert added.
In September 2009, Lombard Medical completed the randomized, controlled Pythagoras Investigational Device Exemption study. This study enrolled 210 patients across 41 US medical centers, as well as three in Canada and one in Poland.
The FDA had granted premarket approval for the company in February 2013 for the Aorfix endovascular stent graft to treat patients with aortic neck angulations between 0-90 degrees.