Lombard Medical's Aorfix Abdominal Aortic Aneurysm Stent Graft Receives FDA Approval

February 15, 2013—Lombard Medical Technologies PLC (Oxfordshire, UK) announced US Food and Drug Administration (FDA) approval for Aorfix, the company's flexible stent graft for the endovascular repair of abdominal aortic aneurysms. The United States approval for Aorfix includes a label indication for the treatment of patients with angulations at the neck of the aneurysm from 0º to 90º.

According to Lombard Medical's press release, the flexible design of the Aorfix endovascular stent graft targets challenging cases with neck angulations greater than 60º. The company noted that approximately 30% of patients have some tortuosity either at the neck of the aneurysm or in the iliac arteries. 

After the FDA approval of the Aorfix, Lombard Medical has allocated funds to market the device in the United States through the company's direct sales force, complete the planned extension of stent graft sizes, and develop the next-generation, lower-profile delivery device.

Lombard Medical stated that FDA approval of the Aorfix device was supported by data from the PYTHAGORAS trial in the United States. PYTHAGORAS was a prospective controlled study of stent grafting in patients with highly angled aortas. The study recruited 218 patients at risk of aneurysm rupture and included 151 patients with neck angles greater than 60º and 67 patients with neck angles less than 60º. The company reported that no aneurysms expanded in patients with neck angles less than 60º, and that 1.8% expanded in the patients with high neck angles, comparing favorably with the results of other devices in normal, less tortuous anatomy.

Mark Fillinger, MD, of Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, served as principal investigator of the PYTHAGORAS trial. In Lombard Medical's press release, Dr. Fillinger commented, “Having seen the benefits of using Aorfix in patients first hand, I am delighted such a device is now available to treat patients in the United States. Aorfix allows a minimally invasive repair of complicated high-angle abdominal aortic aneurysms to be performed, addressing a clear, unmet medical need. These patients would otherwise require relatively high-risk and more expensive open-heart surgery, and many are not strong enough to undergo such a serious intervention.”

The Aorfix device has previously been approved in Europe to treat neck angulations of up to 90º, and Lombard Medical anticipates that the Aorfix will be approved in Japan in 2014.