Endurant AAA Stent Graft Maintains Durable, Consistent and Proven Outcomes for Abdominal Aortic Aneurysm Repair in Long-Term ...
June 20 2015 - 10:00AM
Five-Year Results
from U.S. IDE Study Presented at Society for Vascular Surgery
Meeting
CHICAGO - June 20, 2015 -
Selected for nearly one of every two endovascular abdominal aortic
aneurysm (AAA) repairs globally, the Endurant AAA stent graft
system from Medtronic plc (NYSE: MDT) maintained durable,
consistent and proven outcomes through five years of follow-up in
the company's U.S. clinical study of the implantable medical
device, according to new clinical data presented today at the
Society for Vascular Surgery's "Vascular Annual Meeting."
The five-year results from the study were
presented by Dr. Michael J. Singh, associate professor of surgery
at University of Pittsburgh Medical Center, during a late-breaking
clinical trial session. The prospective, multi-center,
non-randomized bifurcated arm of the study enrolled 150 patients at
26 U.S. medical centers, met its primary safety and effectiveness
endpoints and contributed to the device's approval by the U.S. Food
and Drug Administration in December 2010. The study's primary
safety and effectiveness endpoints were major adverse events (MAE)
at 30 days and successful aneurysm treatment at 12 months,
respectively. Five year follow-up was also conducted.
Significantly for 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 results of the current study demonstrate the
durability of the Endurant system, with very good results up to
five years that appear to be better than older generation
endografts," said Dr. Michel Makaroun, professor and chair,
division of vascular surgery, University of Pittsburgh School of
Medicine and co-director of the UPMC Heart and Vascular Institute
and primary investigator of the trial.
Highlights of the findings include 99.2 percent
freedom from aneurysm related mortality and 89.0 percent freedom
from secondary endovascular interventions through five years. In
addition, an independent imaging core laboratory reported 95.2
percent of the patients' aneurysm sacs remained stable or decreased
in diameter by more than 5 mm at five years. Indicative of
excellent exclusion of the aneurysm, there were no (0.0%) Type I or
III endoleaks at five years and no migrations occurred through the
five-year follow-up.
"The five-year results from this study reinforce
the long-term durability and consistency of the clinical outcomes
that vascular specialists around the world have experienced with
the Endurant AAA stent graft system," Dr. Singh said. "These
results add to the growing body of evidence in support of the
Endurant platform for endovascular AAA repair."
The device also achieved excellent procedural
performance in the study, with successful delivery and deployment
in 99.3 percent of patients and a mean procedure time of 101.5
minutes. Coupled with the long-term clinical outcomes, these
performance characteristics support the economic value of the
Endurant AAA stent graft system.
"By delivering durable and consistent outcomes for
patients with abdominal aortic aneurysms, the Endurant AAA stent
graft system has the potential to deliver economic value to
hospitals as well," explained Dr. Edward Woo, director of the
MedStar Regional Vascular Program, chairman of vascular surgery at
MedStar Washington Hospital Center and professor of surgery at
Georgetown University, who previously presented on the clinical and
economic effectiveness of the Endurant stent graft at Charing Cross
2015 . "These financial benefits come from reducing operational
costs and readmissions.1"
Originally introduced in Europe in 2008, the
Endurant AAA stent graft system has been used to treat
approximately 200,000 patients worldwide -- more than any other
device of its kind. It has been proven in a variety of clinical
studies, including the Endurant U.S. IDE Study, the Endurant Post
Approval Study (PAS) and the ENGAGE registry, to offer durable and
consistent performance for the endovascular treatment of AAA. With
a comprehensive clinical program that includes nearly 2,000
patients, Medtronic continues to study the Endurant Stent Graft
system in both controlled settings and real-world practice.
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 diseases and cardiac arrhythmias. The
company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers
worldwide.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, 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.
-end-
1Woo, E.
"Endurant Stent Graft Has Demonstrated Clinical and Economic
Effectiveness At Mid-Term Follow Up." Charing Cross Congress,
London. April 29 2015.
Contacts:
Krystin Hayward
Public Relations
+1-508-298-8246
Jeff Warren
Investor Relations
+1-763-505-2696
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Source: Medtronic plc via Globenewswire
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