Abbott wins FDA clearance for new cardiac mapping system

Abbott (NYSE:ABT) announced today that it received FDA clearance for its EnSite X EP with EnSite […]

Abbott (NYSE:ABT) announced today that it received FDA clearance for its EnSite X EP with EnSite Omnipolar technology (OT).

The company designed the new cardiac mapping platform, now available in the U.S. and across Europe, to help physicians better treat abnormal heart rhythms (cardiac arrhythmias).

EnSite X EP creates highly detailed, three-dimensional maps of the heart to help physicians identify then treat areas of the heart where abnormal rhythms originate, according to a news release. The system includes Abbott’s proprietary EnSite OT, which uses the Advisor HD grid catheter to provide true electrograms (EGMs) regardless of how the catheter is oriented within the heart.

The ability to sample EGMs in 360 degrees allows the EnSite X EP system with EnSite OT to map 1 million points in the heart and provide a more precise location for treatment areas, Abbott said.

Abbott designed the platform to be upgradable via new software to ensure access to the latest technology without the need for entirely new systems. The company touts the platform as the first mapping system that allows physicians to choose between two methods of cardiac visualization.

“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,” Abbott SVP of Electrophysiology Mike Pederson said in the release. “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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