FRIDLEY (dpa-AFX) - Medtronic Inc. (MDT) announced, on April 15, the two-year results from its U.S. clinical study of the Endurant abdominal aortic aneurysms, or AAA Stent Graft System.
The prospective Endurant U.S. investigational device exemption, or 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 company noted that the market-leading medical device for minimally invasive treatment of Abdominal Aortic Aneurysms continues to show strong safety and efficacy.
'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, Michel Makaroun, professor and chief of vascular surgery at the University of Pittsburgh School of Medicine.
The Endurant U.S. IDE study enrolled 150 AAA patients at 26 U.S. medical centers. 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 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.
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