USFDA clears Abbott's new cardiac mapping system for cardiac arrhythmia

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The United States Food and Drug Administration has cleared Abbott’s  EnSite X EP System with EnSite Omnipolar Technology (OT), a new cardiac mapping platform currently available in the U.S. and Europe designed to help physicians better treat abnormal heart rhythms or cardiac arrhythmias, the company announced on January 12, 2022.

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, the statement added.

“More patients than ever before are benefitting from ablation to treat abnormal heart rhythms, and Abbott's new EnSite X System with EnSite OT, utilising Advisor HD Grid catheter, embodies the latest innovation available to support the treatment of complex and challenging cardiac arrhythmias,” clinical cardiac electrophysiologist with Texas Cardiac Arrhythmia at St. David's Medical Centre in Austin, Texas Dr Amin Al-Ahmad, said.

“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 arrhythmias,” he added.

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, the official statement added.

The company informed that with the ability to sample EGMs in 360 degrees, the system with EnSite OT can map one million points in the heart and provide a more precise location of treatment areas.

More and more doctors are turning to cardiac ablation to treat cardiac arrhythmias because, unlike medication, cardiac ablation treats the condition at the source by disrupting the area of the heart generating abnormal heartbeats, the statement added.

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.

Mike Pederson, the senior vice president, electrophysiology Abbott said that 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.

“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,” he added.

“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,” Pederson further added.


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