Abbott Granted FDA Clearance for the EnSite X EP Cardiac Mapping Platform for the Treatment of Cardiac Arrhythmias

January 12, 2022—Abbott announced that its new cardiac mapping platform, EnSite X EP system with EnSite Omnipolar Technology (OT), received clearance from the FDA. The new system is designed to enable physicians to better treat abnormal heart rhythms.

According to the company, the EnSite X EP system, which was developed with input from electrophysiologists, creates highly detailed three-dimensional maps of the heart to aid physicians in identifying and treating heart arrhythmias where they start. The system includes the EnSite OT, a proprietary technology using the Advisor HD Grid catheter to provide true electrograms regardless of catheter orientation within the heart. The ability to provide a 360° view of the heart allows the EnSite X EP system to map 1 million points in the heart, noted Abbott in their press release.

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

“To continue improving outcomes for our patients, we need a system with speed, stability, and accuracy,” Dr. Al-Ahmad continued. “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.”

Abbott also noted that in designing the EnSite X system, it planned for the platform to be upgradable via new software to ensure physicians consistently have access to the latest technology without the need for entirely new systems. Additionally, the EnSite X EP system with EnSite OT is the first mapping system that allows physicians to choose between unipolar or bipolar measurement principles. Although unipolar measurements have multiple advantages, including direction and speed, bipolar measurements provide local signal measuring to pinpoint areas of concern. The EnSite X EP system brings together both cardiac visualization methods to help maximize data collection.