Medtronic Cardiac Devices Gain FDA Approval to Enable Patient Access to the Most Advanced Diagnostic Imaging
October 13 2016 - 11:00AM
Patients with
SureScan® Pacemakers, ICDs and CRT-Ds Now Can Receive 3 Tesla MRI
Scans
DUBLIN - Oct. 13, 2016 -
Medtronic plc (NYSE:MDT) is the first company to receive U.S. Food
and Drug Administration (FDA) approval for its suite of cardiac
rhythm and heart failure devices and leads to be scanned in both 3
and 1.5 Tesla (T) magnetic resonance imaging (MRI) machines. This
advancement gives patients with Medtronic SureScan®
MR-conditional pacemakers, implantable cardioverter-defibrillators
(ICDs) and cardiac resynchronization therapy-defibrillators
(CRT-Ds) and leads access to MRI scans on any part of the body.
Each year, approximately 12-16 percent of patients
with cardiac devices have a condition in which MRI would normally
be prescribed, but less than 1 percent receive a scan because of
device or lead restrictions.1-4 Before the
availability of MR-conditional technology, patients with cardiac
devices were contraindicated from undergoing MRI scans to avoid a
potential interaction between the MRI and the device function.
"The potential interaction between cardiac devices
and MRIs has been a long-running concern for patients and
physicians," said Marc Silver, M.D., cardiologist at WakeMed Heart
and Vascular Physicians in Raleigh, N.C. "Fortunately, advancements
in MR-conditional cardiac device technology give patients more
access to this important diagnostic tool."
MRI is an important imaging technology to diagnose
conditions such as stroke, cancer, Alzheimer's disease, and muscle,
bone and joint pain. 3T MRI offers better image quality5,6, better
diagnosis7-11 and
reduced scan duration11,12 compared
to 1.5T scans. In the next five years, the adoption of 3T MR
systems is expected to reach approximately 30-40 percent of
hospitals across the U.S.13
"While 1.5T scanners still comprise the majority
of installations, 3T scanners are expected to comprise more than
half of new units - with some centers having only 3T scanners -
since they offer faster scans and higher resolution images," said
Yair Safriel, M.D., neuroradiologist and chief medical officer at
Pharmascan Clinical Trials and University of South Florida.
"Approval for MRI conditional scanning at both 1.5 and 3T allows
patients to have improved access to MRI at a time and place most
appropriate for their care. And with 3T scanning, physicians and
radiologists gain a clearer look into soft tissues, particularly
critical when diagnosing serious conditions, often involving the
brain and spine."
Patients in the U.S. with the following devices
are now eligible for 1.5 and 3T MRI scans:
-
Advisa MRI(TM) Pacemakers
and Micra(TM)
Transcatheter Pacemaker
-
Amplia MRI(TM) and Compia
MRI(TM) Cardiac
Resynchronization Therapy Defibrillators
-
Evera MRI(TM) and Visia
AF(TM) MRI DF-1
and DF4 Implantable Cardioverter Defibrillators
-
Reveal LINQ(TM) Insertable
Cardiac Monitor
-
SureScan®
Pacing, Defibrillation and Left-Heart Leads
Additionally, Medtronic now offers more options
for ICD patients undergoing device replacement surgery, enabling
MRI access to an even broader base of patients.
"Our goal is to help patients get the cardiac
device therapy they need while ensuring they also retain access to
other needed tools, such as diagnostic MRI," said David Steinhaus,
M.D., vice president and general manager of the Heart Failure
business, and medical director for the Cardiac Rhythm and Heart
Failure division of Medtronic. "We are proud to be the first and
only company to offer a comprehensive suite of MR-conditional
devices and leads in the U.S."
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 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-
The Revo MRI(TM) Pacemaker is labeled for 1.5T MRI
only.
1 Data from
2010 MarketScan® Commercial
and Medicare databases from Truven Health Analytics, Inc. were used
to characterize non-pacemaker and pacemaker cohorts and utilization
or radiology services. Cohorts were matched based on age, gender
and comorbidities.
2 Medtronic
data on file 2015: ICD data from MarketScan® 2012
Commercial and Medicare Database, Truven Health
Analytics.
3 Nazarian S,
Reynolds MR, Ryan MP, et al. Utilization and likelihood of
radiologic diagnostic imaging in patients with implantable cardiac
defibrillators. J Magn Reson Imaging. January
2016;43:115-127.
4 Medtronic
data on file 2015: CRT data from MarketScan® 2012
Commercial and Medicare Database, Truven Health
Analytics.
5 Tanenbaum
L. Appl Radiol. 2006;35:34-44.
6
http://www.biomedsearch.com/article/Cardiovascular-MRI-at-3T/209239236.html.
7 Kamada K, et
al. Eur Radiol.
2008;18:2949-2955.
8 Stankiewicz
JM, et al. J Neuroimaging.
2011;21:e50-56.
9 Luccichenti
G, et al. Funct Neurol.
2010;25:109-114.
10 Craven I, et
al. Clin Radiol. 2011;66:278-286.
11
Alvarez-Linera J. Eur J Radiol.
2008;67:415-426.
12 Guo H, et
al. Am J Neuroradiol.
2014;35:504-512.
13 2015 MR
Market Outlook Report, IMV Medical Information Division, Inc.
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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The issuer of this announcement warrants that they are solely
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information contained therein.
Source: Medtronic plc via Globenewswire
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