New Five-Year Gender Subset Data from the Medtronic Engage Registry Presented in VIVA Late Breaking Trials
September 13 2017 - 1:49PM
YASTEST
Five-Year,
Real-World Data Demonstrate EVAR Outcomes with Endurant® II Stent
Graft System Are Comparable in Both Male and Female
Patients
DUBLIN and LAS VEGAS - September
13, 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 among both male and female
patients. The five-year ENGAGE global registry data were presented
for the first time by Marc Schermerhorn, M.D., chief, division of
vascular and endovascular surgery, Beth Israel Deaconess Medical
Center, Boston, Mass., in a late-breaking clinical trial at the
Vascular Interventional Advances (VIVA) 2017 conference in Las
Vegas.
Women have historically demonstrated worse EVAR
outcomes than men due to differences between the female and male
anatomies, including shorter, more angulated aortic necks, smaller
aneurysms, and smaller iliac vessels. Female patients also have
historically demonstrated higher rates of mortality, access
complications, and endoleaks compared to men.
"It is well known in the clinical community that
women have not benefitted to the same extent as men when receiving
an EVAR procedure, and in turn, have become a greatly underserved
patient population," said Dr. Schermerhorn. "Endurant is now the
only stent graft system to close the outcomes gap between men and
women at 30 days, one year, and five years, which sets a new
benchmark for EVAR device performance and has the potential to
change the treatment paradigm for female patients."
The five-year gender subset analysis of the ENGAGE
global registry included 1,263 patients (133 female and 1,130
male). The study population was comprised of females with an
average age of 75.7 years with smaller diameter proximal necks and
narrower access vessels. Approximately 16.5 percent of females
compared to 11.5 percent of males had proximal neck lengths
<15mm and 19.7 percent of females compared to 9.0 percent males
had infrarenal neck angles of >60 degrees. The data underscore
previous findings between men and women at 30-days and one-year,
which demonstrated consistent efficacy and safety.
The five-year data demonstrated a successful
delivery and deployment rate of 99.2 percent in the female cohort
compared to 99.5 percent in the male cohort (p=0.746). The study
also showed consistency between genders, with:
-
A freedom from aneurysm-related mortalities
(ARM) in females of 100.0 percent compared to a 97.5 percent
freedom from ARM in males (p=0.0881)
-
Type Ia endoleaks were observed in 3.8 percent
of females compared to 1.3 percent of males (p=0.197) at five
years
-
A freedom from secondary procedures in females
of 85.6 percent compared to 84.1 percent freedom from secondary
procedures in males (p=0.5150)
-
Aneurysm sac stable or decrease was observed in
89.6 percent of females compared to 89.4 percent of males at five
years
-
A freedom from rupture rate in females of 100.0
percent compared to a 98.4 percent freedom from rupture rate in
males (p=0.2263)
ENGAGE represents the most robust post-market
registry ever initiated in the study of EVAR with 79 sites in 30
countries. The ENGAGE registry was initiated less than one year
post CE Mark and will have 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.
"Our objective has always been to deliver proven,
durable solutions that effectively address varying patient
anatomies and yield long-term clinical outcomes," said Daveen
Chopra, vice president and general manager of the Aortic business
in Medtronic's Cardiac and Vascular Group. "The newly presented
clinical evidence from ENGAGE truly underscores this objective and
validates that Endurant is able to deliver similar technical and
long-term clinical outcomes between genders through five years,
despite significantly challenging female anatomy."
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 of the highest quality 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 in the past five years 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 84,000 people worldwide, serving physicians,
hospitals and patients in more than 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
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information contained therein.
Source: Medtronic plc via Globenewswire
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