Lombard Medical has announced positive long-term data providing confirmation of sustained performance for its Aorfix endovascular stent graft system in the most challenging anatomies.
The data from the only investigational device exemption study to focus on high neck angulation were presented at the 2016 VEITHsymposium (15-17, New York, USA).
Aorfix is designed for highly tortuous anatomy and is the only stent graft to hold global approvals to treat abdominal aortic aneurysms with aortic neck angles up to 90 degrees.
Mahmoud Malas of Johns Hopkins Bayview Medical Center, Baltimore, USA, presented five-year results of the US PYTHAGORAS trial of Aorfix. The trial studied 218 patients, 151 of which had neck angles of 60 degrees and higher—which are off-label for all other approved stent grafts available in the USA. Malas showed that this group of patients had several other characteristics that were predictive of poor outcomes, including a very high percentage of female patients and higher average age.
At the fifth year, there were no type I or III endoleaks. Migration was seen in 3.3% of cases, while freedom from aneurysm-related mortality in patients with neck angles of 60 degrees and greater was 95%. This rose to 99% in patients with neck angles of less than 60 degrees.
Malas concludes, “Despite these patients having severely challenging anatomy and multiple other predictors of poorer outcomes, the performance of Aorfix after five 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.” A paper presenting the full data at five years follow up has been accepted for publication by the Journal of Vascular Surgery.