FDA Grants Clearance To Cardiac Mapping System For Cardiac Arrhythmia Treatment

US Food and Drug Administration

The US Food and Drug Administration (FDA) has granted clearance to the EnSite X EP System with EnSite Omnipolar Technology cardiac mapping platform designed to help physicians treat cardiac arrhythmias.

Clearance for the cardiac mapping system was granted to Abbott.

The system is designed to create highly detailed three-dimensional maps of the heart to help physicians identify and treat areas of the heart where abnormal rhythms originate. The device includes the company’s omnipolar technology which utilized the Advisor HD Grid Catheter to prove true electrograms (EGMs) regardless of the orientation of the catheter in the heart.

As a result of sampling EGMs in 360 degrees, the cardiac mapping platform can map 1 million points in the heart to provide a more precise location of treatment areas. The platform is upgradable via new software to ensure physicians have access to the latest technology, without the need for an entirely new system.

It is the first cardiac mapping system to allow physicians to choose between 2 methods of cardiac visualization, providing both unipolar and bipolar measurement principles to maximize data collection. Unipolar measurements have advantages in direction and speed, while bipolar measurements can provide local signal measuring to pinpoint areas of concern.

Abnormal heart rhythms affect millions of Americans due to breakdowns in the electrical pathways of the heart which cause erratic heart beats and can severely impact a patient's health. The system can help treat one of the most common arrhythmias, atrial fibrillation, which left untreated may lead to stroke or heart failure.

Some physicians have turned to cardiac ablation to treat cardiac arrhythmias, in order to get to the source of the issue and disrupt the area of the heart generating abnormal heart beating. Cardiac mapping can be critical for ablation, because accurate and detailed images of the heart allow physicians to determine the best location for the deployment of a safe and efficacious therapy.

In a statement, Amin Al-Ahmad, MD, Texas Cardiac Arrhythmia at St. David's Medical Center in Austin, Texas, noted the increase of patients who benefitted from ablation to treat complex cardiac arrhythmias and the cardiac mapping device embodied the latest innovation.

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

Mike Pederson, senior vice president, electrophysiology Abbott, additionally stated that innovative and advanced cardiac mapping and imaging tools are essential for physicians to provide the best outcomes for patients.

"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,” Pederson said. “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."