New Data from the
Global ENGAGE Registry Builds on Durability of Endurant, with
Strong Outcomes Out to Four Years in Patients with Standard and
Hostile Neck Anatomies
DUBLIN - Nov. 15, 2016 -
Medtronic plc (NYSE:MDT) today announced data supporting the
strength and durability of the Endurant(TM) II/IIs1
stent graft system to treat abdominal aortic aneurysm (AAA)
patients. The results, presented during the 43rd Annual
Symposium of Vascular and Endovascular Issues (VEITHsymposium) in
New York, are based upon new sub-analyses of Medtronic's ENGAGE
Global Registry, which has enrolled more than 1,200 patients at 79
sites across six continents. With 10-year follow-up planned for all
patients, ENGAGE represents the most robust post-market registry
ever initiated in the study of endovascular aortic repair
(EVAR).
Created with the collaboration of physicians
around the world, the Endurant stent graft system treats AAA using
EVAR. While EVAR is used widely for patients with standard
anatomy, patients with challenging anatomy have historically been
difficult to treat, and are associated with limited eligibility for
endovascular repair and higher rates of secondary
interventions.
In a sub-analysis of ENGAGE presented for the
first time, Prof. Hence Verhagen, M.D., Ph.D., chief of vascular
surgery at Erasmus University Medical Center in Rotterdam, the
Netherlands, reviewed the use of EVAR in patients with both
standard and complex anatomies emphasizing Type Ia endoleaks (an
endoleak characterized by a poor seal at the aortic neck). In a
compelling finding based on the full registry cohort (n=1263),
patients were free from Type Ia endoleaks for up to four years,
with rates of 97.8 percent (one year), 97.3 percent (two years),
96.7 percent (three years), and 96 percent (four years). Similar
results were seen in sub-analyses of both standard and complex
patients at all time points.
"The impact of a Type Ia endoleak is serious and
includes an increased risk of rupture and the need for
reintervention. This new analysis from the four-year global ENGAGE
registry provides further evidence of the benefits of EVAR in
patients with both standard and complex anatomies, and it reflects
the low endoleak rates that can be achieved with the Endurant stent
graft system," said Prof. Verhagen.
A second sub-analysis of the ENGAGE registry data
presented by Prof. Verhagen is one of the largest to date of
long-term outcomes in patients (n>100) with hostile aortic neck
anatomy (highly angulated, conical and circumferential
thrombus/calcium). The results showed that Endurant achieves
positive results in patients with various hostile neck types
followed up to four years. At four years these mid-term outcomes,
such as aneurysm related mortality, rupture and conversion to open
surgical repair, offer clinical insight into the treatment of AAA
neck anatomies that is relevant and applicable to current clinical
practice and real-world settings. "Data from the ongoing global
ENGAGE registry show positive outcomes in several anatomically
challenging sub-groups, including those with hostile aortic necks,"
continued Prof. Verhagen.
Additionally, Prof. Dittmar Böckler, M.D.,
University of Heidelberg, Department of Vascular Surgery in Germany
and ENGAGE investigator, reviewed data from the ENGAGE registry
outcomes with reference to the flagship EVAR 1 study.2
These results, which were first presented at Charing Cross
Symposium in April 2016, showed that Endurant was more effective
than the previous generation of endografts evaluated in EVAR1, with
a 54 percent relative risk reduction in aneurysm-related mortality
rates (ARM), a 44 percent relative risk reduction of rupture, and a
35 percent relative risk reduction in secondary interventions. The
findings support utilization of Endurant in a wide range of
patients.
"The Endurant stent graft system is a great
example of Medtronic's commitment to work together with clinicians
to provide patients with clinically driven, life-saving technology.
With more than 250,000 successful implants, our leadership in EVAR
is supported by deep clinical experience," said Daveen Chopra, vice
president and general manager of the Aortic business, which is part
of the Aortic & Peripheral Vascular division at Medtronic. "The
data from the ENGAGE registry presented at VEITHsymposium adds to
the unmatched clinical experience of Endurant, further
demonstrating why it provides physicians with a durable and
effective solution to treat more patients, including those with
both standard and complex anatomies."
About Endurant Stent Graft
System
Selected for nearly one of every two endovascular AAA repairs
globally and used in more than 250,000 successful implants, the
Endurant stent graft system has been approved in the U.S. since
December 2010. In the U.S., it is indicated for necks >=10 mm
and <=60° infra-renal angulation and >=15mm with <=75°
infra-renal angulation. Since the original Endurant system received
CE Mark approval in June 2008, the ENGAGE registry has enrolled
more than 1,200 patients.
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 43rd 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 5-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. Press will
receive complimentary registration. Please visit www.VEITHpress.org
or contact Pauline T. Mayer at +1-561-316-3330.
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 88,000 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-
1 In the
U.S., the Endurant II/IIs stent system is approved for neck lengths
>=10 mm and <=60° infra-renal angulation.
2 Lancet. 2005
Jun 25-July 1; 365 (9478): 2179-86
Contacts:
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Public Relations
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Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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