ABBOTT PARK, Ill., Jan. 12, 2022 /PRNewswire/ -- Abbott (NYSE:
ABT) today announced it has received clearance from the U.S.
Food and Drug Administration for the EnSite™ X EP System with
EnSite Omnipolar Technology (OT), a new cardiac mapping platform
available in the U.S. and across Europe that is designed to help physicians
better treat abnormal heart rhythms, also known as cardiac
arrhythmias. Designed with input from electrophysiologists from
around the world, the system creates highly detailed
three-dimensional maps of the heart to help physicians identify and
then treat areas of the heart where abnormal rhythms originate.
"More patients than ever before are benefitting from ablation to
treat abnormal heart rhythms, and Abbott's new EnSite X System with EnSite OT,
utilizing Advisor HD Grid catheter, embodies the latest
innovation available to support the treatment of complex and
challenging cardiac arrhythmias," said Amin
Al-Ahmad, M.D., a clinical cardiac electrophysiologist with
Texas Cardiac Arrhythmia at St. David's Medical Center in
Austin, Texas. "To continue
improving outcomes for our patients, we need a system with speed,
stability and accuracy. Abbott has
provided us with a system that not only supports safe and effective
treatment, but enhances the accuracy of maps, allowing for a
clearer understanding of what is going on in the heart and what
areas need to be targeted with ablation to treat arrythmias."
This system includes Abbott's
proprietary EnSite OT, which leverages the Advisor™ HD
Grid Catheter to provide true electrograms (EGMs) regardless of how
the catheter is oriented within the heart. With the ability to
sample EGMs in 360 degrees, the EnSite X EP System with EnSite OT
can map 1 million points in the heart and provide more precise
location of treatment areas. Offering the best of both unipolar and
bipolar measurement principles, the system provides mapping
without compromise.
Millions of Americans are affected by abnormal heart rhythms
caused by breakdowns in the electrical pathways of the heart. Left
untreated, these breakdowns can lead to erratic heartbeats or cause
the heart to beat too fast or too slow, which can dramatically
impact a patient's health. Atrial fibrillation (AFib), the most
common arrhythmia the EnSite X EP System with EnSite OT can help
treat, is a condition in which the heart's chambers are out of
sync, causing them to beat in a rapid and chaotic fashion. In some
cases, untreated arrythmias like AFib may eventually lead to heart
failure or stroke.
Increasingly, physicians are turning to cardiac ablation to
treat cardiac arrhythmias because –unlike medication – the therapy
treats the condition at the source by disrupting the area of the
heart generating abnormal heart beats. Cardiac mapping is
critical to successful ablation therapy because highly precise,
accurate and detailed images of the heart allow physicians to
determine the best location to deploy therapy safely and
effectively.
"As ablation therapy is increasingly used for patients battling
cardiac arrhythmias, new, innovative and advanced cardiac mapping
and imaging tools are essential to help physicians provide the best
outcomes for their patients," said Mike
Pederson, senior vice president, electrophysiology
Abbott. "We developed the EnSite X
System with EnSite OT to enhance the utility of our unique Advisor
HD Grid catheter and allow doctors to quickly and accurately create
real-time, stable, three-dimensional models of the heart. These
models provide a way to precisely identify areas that are causing
problems, so physicians can better treat those abnormal heart
rhythms, and preserve healthy tissue."
Reimagining the Potential of Cardiac Mapping
In
designing the EnSite X System with EnSite OT, Abbott created the platform to be upgradable
via new software, ensuring physicians consistently have access to
the latest technology without the need for entirely new systems. In
addition, EnSite X EP System with EnSite OT is the first
mapping system that allows physicians to choose between two methods
of cardiac visualization.
Traditional mapping systems use either unipolar or bipolar
measurement principles. While unipolar measurements have multiple
advantages, including direction and speed, bipolar measurements
provide local signal measuring to pinpoint areas of concern. The
EnSite X System with EnSite OT brings the best of both measurement
principles together to maximize data collection.
About Cardiac Ablation
When physicians use catheter
ablation to treat cardiac arrhythmias, long flexible tools — called
catheters — are inserted into the heart to study the arrhythmia and
to deliver radio frequency energy. Heat generated from the radio
frequency energy disrupts the cells that are creating the abnormal
heart rhythm. As a result, this tissue is no longer capable of
conducting or sustaining the arrhythmia.
For U.S. important safety information on the EnSite X System
with EnSite OT system, visit
https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x/indications-safety-warnings.html.
About Abbott
Abbott is a global healthcare leader that
helps people live more fully at all stages of life. Our portfolio
of life-changing technologies spans the spectrum of healthcare,
with leading businesses and products in diagnostics, medical
devices, nutritionals and branded generic medicines. Our 109,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
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SOURCE Abbott