Five-Year Data from the Medtronic ENGAGE Registry Demonstrate Durable, Consistent, and Proven Outcomes in Real-World Setting
April 26 2017 - 8:30AM
Presented at
Charing Cross, Five-Year Clinical Data from Global ENGAGE
Registry
Support Endurant II's Market-Leading Position
Worldwide
DUBLIN and LONDON - April 26,
2017 - Medtronic plc (NYSE:MDT) today reported its
Endurant® II abdominal aortic aneurysm (AAA) stent graft system
continues to demonstrate long-term durability and consistent
outcomes in a real-world setting. The five-year ENGAGE global
registry data were presented for the first time at the 2017 Charing
Cross Symposium in London.
The ENGAGE registry evaluated more than 1,200 patients. The
five-year data, which included imaging follow up from approximately
500 of these patients, showed a 97.8 percent freedom from
aneurysm-related mortality (ARM) and a compelling 89.4 percent
stable or decrease diameter AAA sac at five years. The data
demonstrated an 84.3 percent freedom from secondary endovascular
procedures.
"Out to five years, the ENGAGE data showed low ARM
and secondary procedure rates. This further demonstrates both the
benefit of the technique used with Endurant as well as the
durability of the graft itself," said ENGAGE investigator Philippe
Cuypers, M.D., Ph.D., vascular surgeon, Catharina Hospital in
Eindhoven, The Netherlands, who presented the data. "The clinical
rigor and scope of the ENGAGE registry has made it a valuable data
set that represents the types of challenging anatomies physicians
encounter in daily clinical practice."
ENGAGE represents the most robust post-market
registry ever initiated in the study of endovascular aortic repair
(EVAR) with 79 sites in 30 countries. The ENGAGE registry was
initiated less than one year post CE Mark and has clinical follow
up out to 10 years, further demonstrating the Medtronic commitment
to long-term clinical excellence. The goal of ENGAGE remains to
gather evidence in a real-world patient population, including
patients with challenging anatomy who have historically been
difficult to treat, and are associated with limited eligibility for
endovascular repair and higher rates of secondary interventions. A
rigorous monitoring protocol has resulted in a clinical follow-up
compliance of more than 90 percent and imaging compliance of more
than 75 percent at five years.
Data from ENGAGE Featured in Other Key
Presentations at Charing Cross
The Endurant stent graft system was also featured in an additional
presentation that showcases how the ENGAGE data are being used to
inform clinician's treatment decisions following EVAR procedures.
On Wednesday, April 26, 2017, Peter Holt, M.D., senior lecturer and
honorary consultant in vascular surgery at St. George's University
of London presented the design of the LEAR analysis, which aims to
reduce long-term aortic risk using a modified clinical surveillance
program that more accurately portrays reintervention risk.
As demonstrated in Prof. Hence Verhagen, M.D.,
Ph.D., presentation entitled "Safety Considerations with Hostile
Neck 10-15mm," on April 26, 2017, Endurant continues to demonstrate
durable results across a range of patient anatomies, including
patients with more hostile aortic necks, which have historically
been associated with limited eligibility for endovascular repair
and higher rates of adverse events.
"Medtronic aims to increase access to treatment
for patients with Aortic disease. This goal has been reinforced by
our commitment to developing robust clinical programs - such as the
ENGAGE registry - that help clinicians identify durable treatment
options," said Daveen Chopra, vice president and general manager of
the Aortic business in Medtronic's Cardiac and Vascular Group. "In
fact, we are leveraging our strong Endurant stent graft data for a
pilot risk-share program in the U.S. that has been designed to help
decrease customer costs associated with secondary EVAR
interventions."
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 the Endurant II/IIs Stent
System
Selected for nearly one of every two endovascular abdominal aortic
aneurysm (AAA) repairs globally and more than 280,000 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.
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-
Contacts:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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information contained therein.
Source: Medtronic plc via Globenewswire
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