“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”
In short
This year’s Charing Cross International Symposium (CX34) in London has been a much-used vehicle for announcements, not least from Medtronic. According to a press release, results of its two year US clinical study into the performance of its Endurant AAA Stent Graft System bolstering confidence in endovascular repair of abdominal aortic aneurysms (AAA).
Background
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 study
The Endurant U.S. IDE study enrolled 150 AAA patients at 26 U.S. medical centres. 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.
Investigator comments
“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 surgeryat 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.”
Source: Medtronic Inc.
published: April 18, 2012 in: Clinical Studies/Trials, Medtronic, Vascular