EnSite X EP cardiac mapping platform gains US FDA approval

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Abbott Headquarters

Abbott has received clearance from the US Food and Drug Administration (FDA) for the EnSite X EP system with EnSite Omnipolar Technology (OT), a new cardiac mapping platform available in the USA and across Europe that is designed to help physicians better treat abnormal heart rhythms.

The system creates 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, utilising Advisor HD Grid catheter, embodies the latest innovation available to support the treatment of complex and challenging cardiac arrhythmias,” said Amin Al-Ahmad, a clinical cardiac electrophysiologist with Texas Cardiac Arrhythmia at St David’s Medical Center, Austin, USA. “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.”

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.

“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.”


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