Abbott receives FDA clearance for new cardiac mapping system

January 14, 2022 – Abbott 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. 

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. 

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