Medtronic's Endurant AAA Stent Graft Delivers Durable, Consistent and Proven Outcomes at Four Years in Real-World Setting
November 17 2015 - 7:00AM
Four-Year Subset
Analysis from Global ENGAGE Registry Demonstrates Positive Outcomes
in Challenging Anatomies
DUBLIN and NEW YORK CITY-
November 17, 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)
continues to maintain durable and consistent outcomes at four years
in real world settings, including challenging anatomies. Hence J.M.
Verhagen, M.D., Ph.D., Professor and Chief of Vascular Surgery,
Erasmus University Medical Center in Rotterdam, the Netherlands,
presented on the market - leading stent graft on the opening day of
the VEITHsymposium in New York City.
Patients with challenging anatomy have
historically been associated with limited eligibility for
endovascular repair and higher rates of adverse events. Dr.
Verhagen's presentation focused on results across a range of
patient anatomies.
"Analysis of the patient cohort from the four-year
global ENGAGE registry included several anatomically challenging
sub-groups: short, highly angulated, and calcium/thrombus
burdened AAA necks. These mid-term outcomes offer clinical
insight into the treatment of AAA neck anatomies relevant and
applicable to current clinical practice and real world settings,"
said Prof. Verhagen.
At four-years, no significant differences were
found between the short neck (>=10-<15mm) and standard neck
(>=15mm) cohorts in terms of type Ia endoleak rate and AAA
diameter increase. Low rates of aneurysm rupture and conversion to
open surgery were demonstrated through four-year follow-up, and
there was no significant difference between the cohorts in terms of
secondary endovascular procedures. Freedom from
aneurysm-related mortality (ARM) at four-years was 99.2 percent for
the short neck cohort and 98.3 percent for the standard length
necks.
The Endurant stent graft system is approved
outside of the U.S. for use in patients with AAA neck lengths
>=10 mm and <=60° infra-renal angulation and >=15mm with
<=75° infra-renal angulation. In the U.S., the Endurant stent
graft system is indicated for necks >=10 mm and <=60°
infra-renal angulation.
The Endurant system received the CE (Conformité
Européenne) mark in June 2008, and since that time the global
ENGAGE registry has enrolled more than 1,200 patients at 79 sites
across six continents. U.S. Food and Drug Administration (FDA)
approval was received in December 2010. With ten-year follow-up
planned for all patients, the ENGAGE registry represents the most
robust post-market registry ever initiated.
Marc R.H.M. van Sambeek, M.D., Ph.D., Department
of Vascular Surgery, Catharina Hospital, Eindhoven, the
Netherlands, will report on the four-year full cohort analysis from
the global ENGAGE registry on Saturday, November 21.
"The global ENGAGE registry demonstrates
Medtronic's unmatched commitment to clinical research on
endovascular aneurysm repair (EVAR)," said Daveen Chopra, vice
president and general manager of the Aortic business, which is part
of the Aortic & Peripheral Vascular division at Medtronic.
"Through dedication to clinical data and innovation in technology,
we hope to expand EVAR treatments to previously untreatable patient
populations."
In collaboration with leading clinicians,
researchers and scientists worldwide, 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 around the world.
About
VEITHsymposium
Now in its 42nd year,
VEITHsymposium provides vascular surgeons, interventional
radiologists, interventional cardiologists and other vascular
specialists with a unique and exciting format to learn the most
current information about what is new and important in the
treatment of vascular disease. The five day event features
rapid-fire presentations from world renowned vascular specialists
with emphasis on the latest advances, changing concepts in
diagnosis and management, pressing controversies and new
techniques. For more information, please visit www.VEITHpress.org
or contact Pauline T. Mayer at 631.979.3780.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
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-
Contacts:
Krystin Hayward
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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