Medtronic Evera MRI ICD Clinical Study Meets Safety and Efficacy Endpoints
May 14 2015 - 1:30PM
Late-Breaking
Session at Heart Rhythm 2015 Features World's First Randomized
Study of an MRI-Conditional Implantable Cardioverter Defibrillator
Undergoing Full-Body MRI Scans; Study Simultaneously Published
in JACC
DUBLIN and BOSTON - May 14,
2015 - Medtronic plc (NYSE: MDT) today
announced clinical trial results for the Medtronic Evera MRI(TM)
SureScan® implantable cardioverter defibrillator (ICD) following
MRI scans. The study showed that full-body magnetic resonance
imaging (MRI) scans do not affect the Evera MRI ICD's ability to
detect potentially lethal heart rhythms and deliver life-saving
therapy. Data were presented during a late-breaking clinical trial
session at Heart Rhythm 2015, the Heart Rhythm Society's
36th Annual
Scientific Sessions and published simultaneously in the Journal of the American College of Cardiology (JACC).
The Evera MRI Clinical Trial, a multi-center,
prospective, controlled clinical trial, is the first randomized
study of an MRI-conditional ICD system that allows for full-body
1.5 Tesla (the field strength of the magnet) MRI scans. The Evera
MRI ICD includes hardware and software design changes from previous
generation devices that differentiate it from other ICDs and allow
it to undergo full-body MRIs. The Evera MRI ICD System received CE
(Conformité Européenne) Mark in March 2014. The Evera MRI ICD
currently is limited to investigational use in the United
States.
Unlike other studies looking at MRI safety of
ICDs, this robust study included:
-
MRI scans of the chest region, where the device
is in close proximity to the MRI fields, as well as full-body
scans
-
Enrollment of pacing-dependent patients, a
high-risk group of patients who have either no underlying native
heartbeat or an inadequate rate
-
Randomization, to help understand the true
differences in the clinical outcomes post-MRI by comparing the
results to a control group
Currently, patients with ICDs are contraindicated
from receiving MRI scans because of potential interactions between
the MRI and device function, and the resulting risks to patients
who rely on the life-saving therapies of their ICD. As such, there
is a critical unmet need for patients suffering from irregular
heart rhythms who require ICDs and who also have conditions that
warrant MRI scans, which is the gold standard in soft-tissue
imaging. As many as 64 percent of patients with an ICD will need an
MRI within 10 years of receiving a device.1
"The Evera MRI Clinical trial included a broad
range of patients with varying medical conditions and
co-morbidities who underwent full-body MRI scans to assess the
performance of the Evera MRI ICD," said Michael R. Gold, M.D.,
Ph.D., chief of cardiology, Michael E Assey Professor of Medicine
at the Medical University of South Carolina, and principal
investigator in the study. "Our goal was to truly push the limits
of the ICD, in ways that other studies have not, to ensure it is
able to handle the stresses of MRI scans without impacting its
ability to deliver potentially life-saving therapy."
About the Evera MRI Clinical Trial
The study enrolled 275 patients at 42 centers around the world.
Patients were randomized 2:1 to either undergo a series of MRI
sequences of the cardiac, thoracic, cervical and head regions (MRI
group), or a one-hour waiting period without MRI (control group).
An additional subset of patients in the MRI group had ventricular
fibrillation induced following their MRI in order to characterize
arrhythmia sensing, detection and therapy delivery.
The study met the safety endpoint, demonstrating
100 percent freedom from MRI-related complications (p<0.0001) in
the MRI group. The study also met both primary efficacy endpoints.
The percentage of MRI and control patients who experienced changes
in the electrical performance of their ICD system from
pre-MRI/waiting period to one month later was similar:
-
No patients who underwent an MRI experienced a
significant increase in the pacing capture threshold (PCT), the
amount of energy needed to stimulate the heart. These results were
comparable to those in the control group who did not undergo an
MRI. (100 percent of MRI patients versus 98.2 percent of non-MRI
patients experienced a <=0.5 V increase in ventricular pacing
capture threshold, non-inferiority p<0.0001.)
-
99.3 percent of MRI patients and 98.8 percent of
control patients experienced either an increase or a <=50
percent decrease in R-wave amplitude, non-inferiority
p=0.0001
-
The MRI scan did not have any impact on the
Evera MRI device's sensing, detection or therapy delivery in
patients that experienced ventricular tachycardia / ventricular
fibrillation (an abnormally fast or quivering heart rhythm)
post-MRI. (34 cases of VT/VF in 24 patients, of which 20 were
induced and 14 were spontaneous)
"Access to MRI scans is vital to ICD patients,"
said Marshall Stanton, M.D., vice president and general manager,
Tachycardia business, which is part of the Cardiac and Vascular
Group at Medtronic. "Medtronic has long been the leader in
developing implantable devices that are approved for use in an MRI
environment, and we look forward to being able to provide an
MR-conditional ICD to patients."
The Evera MRI ICD is built off of the Evera family
of ICDs and includes the following key features and benefits:
-
A contoured shape with thin, smooth edges that
better fits inside the body, increasing patient comfort by reducing
skin pressure by 30 percent2
-
Industry-leading battery longevity (up to 11
years) compared to previous devices3-10
-
Pairing with Sprint Quattro® Secure ICD leads,
which have 10 years of excellent performance with active
monitoring11 and are the
most prescribed ICD leads ever
-
SmartShock(TM) 2.0, an exclusive shock reduction
algorithm that enables the device to better differentiate between
dangerous and harmless heart rhythms12
-
OptiVol® 2.0 Fluid
Status Monitoring and diagnostics, which is designed to identify
patients at risk of worsening heart failure and atrial
fibrillation
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 the global leader in medical technology - alleviating
pain, restoring health and extending life for millions of people
around the world.
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
Nazarian S, Reynolds M, Ryan M, et al. Estimating the Likelihood of
MRI in Patients After ICD Implanation: A 10-Year Prediction Model.
J Am Coll Cardiol. 2015;65(10S)
2
Flo, Daniel. Device Shape Analysis. January 2013. Medtronic
data on file.
3
Knops P, Theuns DA, Res JC, et al. Analysis of implantable
defibrillator longevity under clinical circumstances: implications
for device selection. Pacing Clin Electrophysiol. October
2009;32(10):1276-1285.
4 Schaer
BA, Koller MT, Sticherling C, et al. Longevity of implantable
cardioverter defibrillators,influencing factors, and comparison to
industry-projected longevity. Heart Rhythm. December
2009;6(12):1737-1743.
5
Biffi M, Ziacchi M, Bertini M, et al. Longevity of implantable
cardioverter-defibrillators: implications for clinical practice and
health care systems. Europace. November
2008;10(12):1288-1295.
6
Kallinen L, et al. 2009.
http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=1913.
7
Thijssen J, Borleffs CJ, van Rees JB, et al. Implantable
cardioverter-defibrillator longevity under clinical circumstances:
an analysis according to device type, generation, and manufacturer.
Heart Rhythm. April 2012;9(4):513-519.
8
Shafat T, Baumfeld Y, Novack V, et al. Significant differences in
the expected versus observed longevity of implantable cardioverter
defibrillators (ICDs). Clin Res Cardiol. Published online July 14,
2012.
9
Horlbeck FW, Mellert F, Kreuz J, et al. Real-world data on the
lifespan of implantable cardioverter-defibrillators depending on
manufacturers and the amount of ventricular pacing. J Cardiovasc
Electrophysiol. December 2012;23(12):1336-1342.
10
Evera XT DR/VR Manual.
11
Medtronic Product Performance Report, 2012 Second Edition, Issue
66.
12
Auricchio, Angelo et al. Low inappropriate shock rates in patients
with single- and dual/triple-chamber implantable
cardioverter-defibrillators using a novel suite of detection
algorithms: PainFree SST trial primary results. Heart Rhythm. 2015
May;12(5):926-936
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Jeff Warren
Investor Relations
+1-763-505-2696
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information contained therein.
Source: Medtronic plc via Globenewswire
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