Medtronic has announced the two-year results from its US clinical study of the Endurant AAA stent graft system, used to treat patients with abdominal aortic aneurysms (AAA) with a minimally invasive technique, called endovascular aortic repair (EVAR).
Endurant is a flexible wire frame sewn into a specially woven fabric tube, which can be used by physicians to create new paths for blood flow in the patient's aorta. The stent graft is delivered through catheters inserted into blood vessels in the groin, and is designed to conform to a variety of aortic anatomies.
The prospective Endurant investigational device exemption (IDE) study enrolled 150 AAA patients with landing zones, or healthy aortic neck lengths, as short as 10mm, at 26 US-based medical centres.
The trial monitored changes in aneurysm size and stent graft migration, as well as the occurrence and type of endoleaks, and found that nearly all of the aneurysm sacs that were treated with the Endurant AAA stent graft decreased or remained stable in size at two years post-procedure, with only 0.8% type I and no type III endoleaks. In addition, the study demonstrated durable clinical performance of the Endurant graft with safety and efficacy in long-term follow-up.
Michel Makaroun, University of Pittsburgh School of Medicine vascular surgery chief and study investigator, said the Endurant stent graft is performing just as well at two years as it did after one, with no aneurysm-related mortalities, migrations or conversions.
"Freedom from aneurysm-related mortality and secondary interventions demonstrate favourable trends versus earlier generation devices. This finding will continue to play a critical role in improving the minimally-invasive treatment of patients with abdominal aortic aneurysms," Makaroun added.
Abdominal aortic aneurysms are weakenings or bulges in the segment of the aorta which crosses through the abdomen, and AAA is often called a silent killer as it rarely causes apparent symptoms until rupturing.
Image: Medtronic World Headquarters, Fridley, Minnesota, US. Photo: Bobak Ha'Eri.