Lombard touts 5-year Aorfix stent graft data

Lombard Medical Technologies (NSDQ:EVAR) yesterday released 5-year results from the Pythagoras trial of its Aorfix, which aimed to evaluate the safety and effectiveness of the stent graft in treating highly angulated aortic necks or tortuous aortoiliac anatomy. A presentation based on data from the study was presented at the 2016 Society for Vascular Surgery’s annual meeting in National Harbor, Maryland this week, the company said. A total of 87% of surviving patients in the 218 patient trial were followed-up with at 5 years, Lombard said, with 60% of angled neck patients showing significant aneurysm sac shrinkage. Patients with low angle aortic necks reported similar outcomes, the company said. “The U.S. Pythagoras trial is the first EVAR clinical trial to include a majority of highly angulated (greater than 60 degree) 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 ris...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Vascular Lombard Medical Source Type: news