Medtronic Demonstrates Commitment to EVAR in Comparison Study of ENGAGE Global Registry and Landmark EVAR 1 Trial
April 27 2016 - 11:00AM
Clinical Integrity
on Display through Longest Term Data of 1,200 Endurant AAA Stent
Graft Patients
DUBLIN AND LONDON - April 27,
2016 - Medtronic plc (NYSE:MDT) today reported on the ENGAGE
global registry of experiences with the Endurant® AAA stent graft
system from Medtronic with a reference to the landmark EVAR 1
Trial. ENGAGE represents the most robust post-market registry ever
initiated in the study of endovascular aortic repair (EVAR) with
more than 1,200 patients at 79 sites across six continents and
ten-year follow-up planned for all patients. A decade ago in a
breakthrough conclusion, EVAR 1 demonstrated better
aneurysm-related survival for EVAR over open surgery. Today's
comparison comes from a presentation at the 2016 Charing Cross
Symposium in London.
Professor Roger Greenhalgh, M.D., Charing Cross
chairman and author of the EVAR 1 Trial stated, "The EVAR 1 trial
is the world's first randomized, controlled trial of EVAR compared
with open repair using devices implanted between 1999 and
2005. It is therefore an appropriate benchmark against which
newer generation devices can be compared."
Dittmar Böckler, M.D., University of Heidelberg,
Department of Vascular Surgery in Germany and ENGAGE investigator
today presented ENGAGE registry outcomes with reference to EVAR
1.
Aneurysm-related mortality was 1.6 percent in the
ENGAGE registry through four years.1 EVAR 1
reported aneurysm-related mortality of 3.5 percent for EVAR and 6.3
percent for open surgery.2 The ENGAGE
Registry also reported a lower rupture rate than in EVAR 1, as well
as a decreased secondary intervention rate.
"In the comparison analysis of ENGAGE and EVAR 1
we can see just how far our medical advancements have come in
improving patient outcomes with EVAR," said Prof. Böckler.
"The very well-structured EVAR 1 gave us the opportunity to
understand the urgent need of improvement in EVAR, especially in
mid- and long-term endograft behavior. Thanks to large real world
registries, such as ENGAGE, we can do scrupulous analysis of
different subgroups' outcomes. The commitment from Medtronic to
support a robust large scale registry is the type of clinical rigor
that interventionalists have come to rely on and will propel us
into the future in treating more challenging anatomies with
minimally invasive options and long-term durability."
Selected for nearly one of every two endovascular
abdominal aortic aneurysm (AAA) repairs globally and more than
200,000 successful implants, the Endurant system received the CE
(Conformité Européenne) Mark in June 2008. U.S. Food and Drug
Administration (FDA) approval was received in December 2010. 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.
At the 2015 VEITHsymposium, ENGAGE registry data demonstrated that
the Endurant AAA Stent Graft delivers durable, consistent and
proven outcomes at four years in real-world settings.
"Medtronic's commitment to improving patient
outcomes through clinical rigor is unsurpassed," said Daveen
Chopra, vice president and general manager of the Aortic business,
which is part of the Aortic & Peripheral Vascular division at
Medtronic. "As the leader in EVAR, we continue to build upon our
success and learnings from ENGAGE to treat more complex aortic
disease."
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 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-
1 Veith
Symposium, 2015: Medtronic data on file
2 Lancet.
2005 Jun 25-July 1; 365 (9478): 2179-86
Contacts:
Kena Hudson
Public Relations
+1-510-246-0163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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