US-based Medtronic has reported that the new data from a pair of clinical trials evaluating its Endurant stent graft for abdominal aortic aneurysms affirmed the Endurant stent graft's durable, consistent and proven outcomes endovascular treatment of abdominal aortic aneurysms (AAA).
The data, from the independent Pandora study and the Medtronic-sponsored Engage trial, demonstrated low rates of aneurysm-related mortality, reintervention, stent graft migration and conversion to open surgery through three to five years of follow-up.
According to the company, the 273-patient Pandora trial (Prospective evAluation of the eNDurant endOprosthesis for the treatment of abdominal aoRtic Aneurysms), an ‘all-comers’ study, met its primary endpoint of reintervention in 9.5% of cases over a median period of more than 3.5years.
Secondary endpoints for proximal migration (0%), Type I/III endoleaks (2%) and AAA-related death (0.3%) were also met, according to the company.
Professor Hence Verhagen from Erasmus Medical Center in Rotterdam, the Netherlands presented the ENGAGE neck-length analysis at Charing Cross international symposium in London.
Professor Verhagen said the Endurant stent graft has opened up standard EVAR to patients who were previously considered ineligible, and the ENGAGE results support the usage of this device in patients with short necks (10mm and up).
"The data also show that the Endurant stent graft successfully broadens patient eligibility for standard EVAR," he added.
The Endurant stent graft is approved for use in patients with neck lengths of 10mm or greater, depending on the device’s regional labeling for angulation (60 degrees in the US; 75 degrees in Europe and other countries that recognize the CE mark).