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Abbott receives U.S. FDA clearance for new cardiac mapping system to improve how doctors treat abnormal heart rhythms

Press releases may be edited for formatting or style | January 12, 2022 Cardiology
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.
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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.

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