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January 13, 2022

FDA approves Abbott’s cardiac mapping system to treat cardiac arrhythmia

The EnSite X EP System with EnSite OT provides a 360° view of the heart for cardiac mapping.

The US Food and Drug Administration (FDA) has granted clearance to Abbott’s new cardiac mapping platform, EnSite X EP System with EnSite Omnipolar Technology (OT), which is designed to help physicians treat cardiac arrhythmias.

Available in the US and across Europe, the system is designed to create detailed 3D maps of the heart that allow surgeons to identify and treat areas where arrhythmias originate.

The device includes the company’s EnSite OT, which uses the Advisor HD Grid Catheter to provide true electrograms (EGMs) regardless of catheter orientation in the heart.

The EnSite X EP System with EnSite OT has the ability to provide a 360° view of the heart for cardiac mapping.

This allows the system to map one million points in the heart, which helps to identify the precise locations of areas that require treatment.

Abbott electrophysiology senior vice-president Mike Pederson said: “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.

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“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.”

The company stated that the EnSite X EP System with EnSite OT offers the best of unipolar and bipolar measurement principles to provide cardiac mapping without compromise.

Furthermore, the device is claimed to be the first mapping system that allows doctors to use both cardiac visualisation methods.

Last November, Abbott submitted positive data from the Leadless II IDE trial, which evaluated its Aveir leadless pacemaker in patients with certain types of abnormal rhythms, to the FDA.

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