Lombard Medical presents IDE data on Aorfix
The 218-patient study, which had 151 patients with neck angles of 60° or more, showed no Type I or Type III endoleaks at 5 years, with a 3.3% rate of migration, freedom from aneurysm-related mortality of 95% among the 60°+ cohort and 99% in patients with less-acute neck angles.
“Despite these patients having severely challenging anatomy and multiple other predictors of poorer outcomes, the performance of Aorfix after 5 years of implantation is very similar to that of competitor devices used in normal risk patients. This important long-term data from a unique study into challenging anatomy supports the use of Aorfix in patients with both normal and tortuous anatomy,” presenter Dr. Mahmoud Malas, of the Johns Hopkins Bayview Medical Center,m said in prepared remarks.
“The long-term data from Pythagoras clearly demonstrates that Aorfix is a high-performing, reliable graft in both the short and long term and it has demonstrated this performance in a unique study focused on patients with highly angled and challenging aortic neck anatomy. The low incidence of migration and endoleak combine to give our patients good long-term protection from their aneurysms even in this most challenging group. The new IntelliFlex delivery system has been very well received since our recent controlled launch in Europe, and we anticipate approval and launch in the important Japanese market in the coming months,” added Lombard CEO Simon Hubbert.