Medtronic (NYSE:MDT) yesterday said its Endurant AAA stent graft is performing well in patients who have abdominal aortic aneurysms with short and standard neck lengths, based on an analysis of more than 1,200 patients in its global Engage registry.
Researchers based their findings on an analysis of 1,237 abdominal aortic aneurysm patients from Engage, which Fridley, Minn.-based Medtronic called the largest post-approval database on a single company’s stent graft.
Medtronic said that 137 patients had short-neck aneurysms of 8mm to 15mm and 1,100 had standard-neck aneurysms of 15mm or greater. Endurant performed well in both situations, with a 99.4% success rate in standard-neck patients and 100% in short-neck patients.
"While neck length remains an important consideration for endovascular repair of abdominal aortic aneurysms, data from the Engage registry show that the Endurant AAA stent graft system can address patients with short and standard necks equally well. In light of these findings, endovascular repair using fenestrated or branched stent graft systems should be limited to patients with especially short necks coupled with other anatomical challenges. The findings also support offering standard endovascular repair with the Endurant system to a broad set of patients with the appropriate anatomy," said Dr. Hence Verhagen of Rotterdam’s Erasmus Medical Center in Rotterdam, who presented the results at the Charing Cross International Symposium in London yesterday.
Medtronic vice president Daveen Chopra added that Engage’s 10-year follow-up protocol "represents the most robust long-term evaluation of any stent graft ever undertaken."
In December, Medtronic cited positive long-term data from a U.S. IDE clinical trial that enrolled 150 patients, as well as positive four-year results from the first 500 patients in the Engage registry.