Bolstering confidence in endovascular repair of abdominal aortic aneurysms (AAA), Medtronic Inc. (NYSE:MDT) announced yesterday the two-year results from its U.S. clinical study of the Endurant AAA Stent Graft System, the global market leader in its product category.
Presented at this year’s Charing Cross International Symposium (CX34) in London, the prospective Endurant U.S. investigational device exemption (IDE) study’s complete results at two years continue to demonstrate durable clinical performance with strong safety and efficacy in long-term follow-up. These results add to a growing body of evidence on the Endurant AAA Stent Graft, which continues to deliver consistent clinical results in both controlled trials and real-world registries.
“The Endurant Stent Graft is performing just as well at two years as it did at one year, with no aneurysm-related mortalities, migrations or conversions,” said the study’s principal investigator, Dr. Michel Makaroun, professor and chief of vascular surgery at the University of Pittsburgh School of Medicine. “Freedom from aneurysm-related mortality and secondary interventions demonstrate favorable 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.”
The Endurant U.S. IDE study enrolled 150 AAA patients at 26 U.S. medical centers. Significant to clinical practice, the study included patients with “landing zones,” or healthy aortic neck lengths, as short as 10 mm, whereas most other trials of aortic stent grafts have required neck lengths of at least 15 mm. The study also monitored changes in aneurysm size and stent graft migration, a concern with current endovascular treatment, as well as the occurrence and type of endoleaks.
The study found that nearly all (97.6 percent) 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 percent Type I endoleaks and no Type III endoleaks.
In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology –– alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.