Lombard Medical Technologies out of Oxfordshire, UK won FDA clearance for its Aorfix stent system for treatment of abdominal aortic aneurysms (AAA). It was developed with the goal of having more AAA patients, particularly those with tortuous anatomies, be able to take advantage of stenting. The device is positioned using the Aorflex delivery system and can fit aortas with a proximal neck angulation up to 90°. From the announcement:
The U.S. approval for Aorfix™ includes a label indication for the treatment of patients with angulations at the neck of the aneurysm from 0 to 90 degrees. Aorfix™ is now the only endovascular stent graft licensed in the U.S. for use in more challenging cases with neck angulations greater than 60 degrees.
The PYTHAGORAS trial of Aorfix™ is the largest prospective controlled study, to date, of stent grafting in patients with highly angled aortas. 218 patients at risk of aneurysm rupture were recruited in the trial and included 151 patients with neck angles greater than 60 degrees and 67 patients with neck angles less than 60 degrees. No aneurysms expanded in patients with neck angles less than 60 degrees and just 1.8% expanded in the patients with high neck angles, comparing favourably with the results of other devices in normal, less tortuous anatomy.
Product page: Aorfix…
Press release: U.S. FDA Approval of Aorfix™