ABBOTT PARK, Ill., Feb. 1, 2017
/PRNewswire/ -- Abbott (NYSE: ABT) today announced U.S. Food
and Drug Administration (FDA) approval for magnetic resonance
(MR)-conditional labeling for both the Assurity MRI™ pacemaker and
the Tendril™ MRI pacing lead. Patients implanted with these
low-voltage devices will have the ability to undergo full body
magnetic resonance imaging (MRI) scans, if required. With the
approval, the Assurity MRI pacemaker is now the world's smallest,
longest-lasting wireless MRI-compatible pacemaker.
The Assurity MRI pacemaker also offers wireless remote
monitoring, providing physicians secure access to their patients'
diagnostic data and daily device measurements and reducing the need
for in-office visits. Remote monitoring of cardiac patients has
become a best practice over the past decade, and studies have
continued to prove its positive impact on patient outcomes and the
reduction of health care costs. In 2015, the Heart Rhythm Society
made wireless remote monitoring the standard of care in its
guidelines.
Pacemakers that allow patients to undergo MRI scans, such as the
Assurity MRI pacemaker, have become an important advancement for
patients who may need an MRI in the future but who do not want to
risk damage to their implant. During an MRI scan, the Assurity MRI
pacemaker works with Abbott's MRI Activator™ handheld device to
trigger pre-programmed MRI settings appropriately tailored to
individual patients. This unique technology can help eliminate the
effort, time and patient inconvenience commonly associated with
conventional pre- and post-scan pacemaker reprogramming.
"A long-lasting and small wireless pacemaker that allows
patients to undergo MRI scans is an important step forward in
growing our available treatment options for patients," said
David Sandler, M.D., director of
electrophysiology at the Oklahoma Heart Institute in Tulsa, Okla. "The ability to choose a device
to best address a patient's cardiac condition no longer has a
tradeoff with MRI compatibility. It's the best of both worlds."
Abbott has continued to build its portfolio of MRI-labeled
products, and continues to work with regulatory agencies around the
world to secure approval for MR-conditional labeling for many of
its most commonly implanted pacemakers, implantable cardioverter
defibrillators (ICDs) and cardiac resynchronization therapy (CRT)
devices.
"Our proven Tendril MRI pacing lead — which has been implanted
in more than 200,000 patients worldwide — along with the latest
approved MR-conditional labeling for our Assurity MRI pacemaker,
will help provide patients access to diagnostic procedures while
delivering the product performance physicians need to provide the
best possible care to their patients," said Avi Fischer, M.D., medical director for Abbott's
Cardiac Rhythm Management business.
ABOUT PACEMAKERS
A pacemaker is a small, low-voltage
implantable device that sends electrical pulses to the heart if the
heart is beating too slowly. More than 4 million people worldwide
have an implanted pacemaker or other cardiac rhythm management
device, and an additional 700,000 patients receive the devices each
year.
A pacemaker monitors the heart's rate (how fast or slow it
beats) and rhythm (the pattern in which it beats), and it provides
electrical stimulation when the heart beats too slowly. Pacemakers
can reduce symptoms of dizziness and fatigue when brought on by a
slow heart rhythm, helping patients enjoy a better quality of
life.
A lead is a thin insulated wire that is placed through the veins
and into the heart as part of a pacemaker implantation procedure.
The tip of the lead is attached to the heart tissue, and the other
end connects to the pacemaker. The lead carries electrical impulses
from the pacemaker to the heart and transmits information from the
heart back to the implanted device.
Some pacemakers are referred to as "MR-conditional" or "MRI
ready." This means that they are designed to allow you to safely
undergo an MRI scan under certain conditions. By having a pacemaker
implanted that allows MRI scans, you will have access to what many
physicians consider their preferred diagnostic tool. MRI scans are
considered the imaging modality that offers the most information to
medical professionals when making a patient diagnosis because of
the very detailed images it provides, combined with the low risk of
radiation.
ABOUT ABBOTT'S CARDIAC RHYTHM MANAGEMENT (CRM)
TECHNOLOGIES
Abbott collaborates with world-renowned
electrophysiologists, clinicians and hospital administrators to
develop safe and cost-effective treatment solutions for patients in
need of advanced CRM devices.
For more information about Abbott's focus on cardiac rhythm
management, visit www.sjm.com/en/patients/arrhythmias.
About Abbott:
At Abbott, we're committed to helping
people live their best possible life through the power of health.
For more than 125 years, we've brought new products and
technologies to the world -- in nutrition, diagnostics, medical
devices and branded generic pharmaceuticals -- that create more
possibilities for more people at all stages of life. Today, 94,000
of us are working to help people live not just longer, but better,
in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
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SOURCE Abbott