Market-Leading Medical Device for Minimally Invasive Treatment of
Abdominal Aortic Aneurysms Continues to Demonstrate Strong Safety and
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
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
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.
Joe McGrath, 707-591-7367
Jeff Warren, 763-505-2696