Abbott’s New Cardiac Mapping System Gets FDA Clearance for Treatment of Cardiac Arrhythmias

Abbott’s new cardiac mapping platform, EnSite X EP System, has received clearance from the US Food and Drug Administration (FDA) for the treatment of cardiac arrhythmias.

The cardiac mapping system incorporates Abbott’s proprietary EnSite Omnipolar Technology (OT), which allows for 360° mapping to generate better and “true” electrograms (EGM) using the Advisor HD Grid Catheter. It can provide detailed images irrespective of the orientation of an inserted catheter.

The EnSite X EP System’s 360-degree sampling of EGMs allows for the mapping of 1 million points in the heart, which can help identify the exact locations that need treatment.

Abbott says the cardiac mapping device offers the best of both unipolar and bipolar measurement principles to generate powerful mapping “without compromise.”

Generating clearer images of the heart is key to better identifying areas involved in arrhythmias and potentially other cardiac issues.

Abnormal heart rhythms are caused by faulty electrical pathways of the heart. If not treated, the electrical breakdowns can lead to irregular heartbeats or cause the heart to beat too fast or too slow.

Atrial fibrillation (AFib) is the most common arrhythmia that the EnSite X EP System with EnSite OT can help treat. The condition occurs when the heart’s four chambers are not in sync, leading them to beat rapidly and erratically. If left untreated, some arrhythmias like AFib may ultimately lead to heart failure or stroke.

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Clinicians have recently been favoring cardiac ablation to treat cardiac arrhythmias because it treats the condition at the source, unlike medications. Ablations target the specific area of the heart that is causing abnormal heartbeats. Pinpointing the exact location of the source of the arrhythmia to be ablated requires effective cardiac mapping. This requires highly precise, accurate and detailed images of the heart so that physicians can administer ablation therapy in a safe and effective manner.

Cardiac arrhythmias are typically treated with catheter ablation, which involves the insertion of catheters to pinpoint the arrhythmia and deliver radiofrequency energy to it; the heat from it targets cells causing the aberrant heart rhythm.

“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 in a press release from the company.

Pederson explained that the company “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.”

Improved, Precision Cardiac Mapping

The EnSite X System with EnSite OT cardiac mapping platform was designed so that it can be upgraded through new software, which will allow physicians to have access to the latest technology without the need for entirely new systems, says Abbott.

The company also claims that the device is the first cardiac mapping system that offers the choice of both unipolar and bipolar measurement-based cardiac visualization.

Conventional mapping systems utilize either unipolar or bipolar measurement principles. Unipolar measurements have several advantages such as directionality and speed, but bipolar measurements provide more precise localization through local signal measuring. The EnSite X System with EnSite OT cardiac mapping system brings the best of both measurement principles together to maximize data collection, says Abbott.

Last summer, Abbott debuted its insertable cardiac monitor (ICM), Jot Dx, which allows for a more accurate diagnosis of heart arrhythmias as it allows for continuous remote monitoring using Bluetooth connectivity.