US-based medical device company Lombard Medical has reported positive clinical results from the Pythagoras trial of the Aorfix endograft to treat highly angulated aortic necks or uncomfortable aortoiliac anatomy.
Aorfix is an endovascular stent graft system designed to treat infra-renal aortic and aorto-iliac aneurysms, also known as abdominal aortic aneurysms (AAAs).
The Pythagoras clinical trial included 218 patients, 151 of which had high neck angles.
The usage of Aorfix in the trial resulted to aneurysm sac shrinkage in 60% of angled neck patients within five years. Low angle patients also witnessed similar results.
Johns Hopkins Bayview Medical Center endovascular surgery director Mahmoud Malas said: "The US Pythagoras trial is the first endovascular aneurysm repair (EVAR) clinical trial to include a majority of highly angulated (greater than 600) infra-renal aortic necks, as well as a higher percentage of female patients (29%).
"Moreover, the suitability of patients to be included was determined by the investigators rather than the company, resulting in many more ‘real-world’ cases being recruited.
"Angulation alone has been associated with worse outcomes in EVAR and unfortunately, female EVAR patients usually have complication rates that far exceed those of males. These factors and the addition of ‘real-world’ anatomy made the study group of patients highly challenging from many perspectives. Pertinent outcomes were better than or similar to trials that did not have these risk factors.
"The results attest to the long-term durability of the Aorfix design and support the use of this endovascular option, which is on-label even in patients with hostile anatomy, including highly angulated aortic necks."
After being placed within the aneurysm, Aorfix decreases the risk of a rupture by creating an internal bypass of the aneurysm.
Its helical and circular design allows it to adjust to the anatomical variations of the human body including aortic necks with high angulations and iliac arteries with extreme bends.
Image: Arrows indicating an abdominal aortic aneurysm. Photo: courtesy of Bakerstmd via Wikipedia.