Medtronic First to Receive FDA Approval for MR-Conditional Cardiac Resynchronization Therapy-Defibrillators
February 05 2016 - 7:00AM
Amplia MRI(TM) and
Compia MRI(TM) CRT-Ds, Approved for Patients with Heart Failure,
Can Safely Undergo Full Body MRI Scans
DUBLIN - Feb. 5, 2016 -
Medtronic plc (NYSE:MDT) today announced that it has received U.S.
Food and Drug Administration (FDA) approval for the first and only
magnetic resonance imaging (MRI) conditional cardiac
resynchronization therapy defibrillators (CRT-Ds) for the treatment
of heart failure. The Medtronic Amplia MRI(TM) Quad CRT-D SureScan®
and Compia MRI(TM) Quad CRT-D SureScan® systems are approved for
MRI scans on any part of the body without positioning restrictions.
Now, patients in the U.S. who receive these devices, which help
treat their heart failure and reduce their risk of sudden cardiac
arrest, have access to MRI scans if and when they need them. Both
CRT-D systems will be commercially available in the coming
months.
"What's clear from the data and my own
personal experience is that a large majority of CRT-D patients will
likely need an MRI at some point. Now that CRT-D MRI devices
are approved, patients can receive an MRI in a straightforward
manner," said J. Rod Gimbel, M.D., Case Western Reserve University.
"This is a significant development for heart failure patients with
CRT-D therapy."
Known as the world's largest and leading cardiac
device manufacturer, Medtronic was the first company to receive FDA
approval for MR-conditional pacemakers (2011) and implantable
cardioverter defibrillators (ICDs) in 2015, and now CRT-D
devices.
Until now, CRT-Ds have been contraindicated by the
FDA to undergo MRI scans because of the potential interaction
between the MRI and the device, resulting in risk to patients.
However, as many as 40 percent of CRT patients will need an MRI
within four years after receiving a device1. As a result,
thousands of heart failure patients implanted with CRT-Ds have not
had access to MRI scans, which are used to diagnose conditions such
as stroke, cancer, Alzheimer's disease, and muscle, bone and joint
pain. Additionally, the Centers for Medicare and Medicaid Services
(CMS) do not reimburse for MRI scans conducted on patients with
non-MR-conditional implanted cardiac devices.
The Amplia MRI and Compia MRI CRT-Ds with
quadripolar technology offer physicians multiple options to help
treat heart failure by optimizing CRT delivery, which may improve
patient outcomes.
The Amplia MRI device features the AdaptivCRT®
algorithm, which has been shown to reduce a patient's odds of a
heart failure hospital readmission (within 30 days) by 59 percent
(versus echo-optimized CRT)2. The
AdaptivCRT feature also has been shown to improve CRT response rate
by 12 percent3, and to
reduce AF risk by 46 percent compared to echo-optimized BiV
pacing.4
Both newly approved devices can be paired with the
Attain(TM) Perfoma(TM) MRI SureScan(TM) Quadripolar Leads, of which
the entire portfolio is approved for MRI scans: Dual Cant MRI
SureScan(TM) Model 4298, Straight MRI SureScan(TM) Model 4398 and S
MRI SureScan(TM) Model 4598. With 16 pacing configurations and
shorter spacing between the two center electrodes, these
quadripolar leads have been shown to reduce the incidence of
phrenic nerve stimulation (PNS), a potential issue associated with
CRT therapy that results in muscle twitching, hiccups or shortness
of breath.5 Attain
Performa leads also include steroid on all four electrodes for
lower chronic pacing thresholds, which contribute to greater device
longevity and reduce the likelihood of PNS.6 The
systems also include VectorExpress(TM) technology, an automated
in-office test that reduces lead programing to two
minutes,7 and reveals
clinically actionable information to help physicians select optimal
pacing configurations for each patient.
"With FDA approval of Amplia MRI and Compia MRI,
Medtronic continues to lead the market in MR-conditional
implantable cardiac devices, bringing greater access to patients
that need this vital diagnostic test to identify other potential
life-threatening diseases," 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. "Medtronic is committed to continuing to develop
innovative technologies that offer physicians a wide range of
technology options to help them improve outcomes for heart failure
patients."
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.
Multimedia Release
A multimedia version of this release, with animation and
downloadable graphics can be found at: http://bit.ly/1mb0Pok
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 Medtronic
data on file 2015: Data from MarketScan® 2012 Commercial and
Medicare Database. Truven Health Analytics.
2 Starling RC,
Krum H, Bril S, Tsintzos SI, Rogers T, Hudnall JH, Martin DO.
Impact of a Novel Adaptive Optimization Algorithm on 30-Day
Readmissions: Evidence from the Adaptive CRT Trial, JACC: Heart Failure (2015), doi:
10.1016/j.chf.2015.03.001.
3 Tarab AD,
Dougher CE, Rogers TB, et al. Budget impact on selecting cardiac
resynchronization therapy (CRT) devices with adaptive ("aCRT")
programming algorithms under the Unites States Medicare Payment
Setting. Value Health. November 2012; 15(7):
A349.
4 Martin D, et
al. Clinical Outcomes with Adaptive Cardiac Resynchronization
Therapy: Long-term Outcomes of the Adaptive CRT Trial. HFSA Late Breakers. September 23, 2013.
5 Biffi et al.
Effort of Bipolar Electrode Spacing on Phrenic Nerve Stimulation
and Left Ventricular Pacing Thresholds: An Acute Canine Study.
Circulation Arrhythmia and Electrophysiology. 2012.
6 Lunati MG,
Gasparini M, Landolina M, et al. Long-Term Effect of Steroid
Elution on the Electrical Performance of Coronary Sinus Leads for
Cardiac Resynchronization Therapy. Presented at HRS 2012
(AB10-05).
7 Demmer, W.
VectorExpress Performance Results. Medtronic data on file. January
2013.
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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