Abbott Gets FDA’s 510(k) Clearance for EnSite X EP Cardiac Mapping System

Abbott has received the FDA’s 510(k) clearance for its EnSite X EP system, a mapping platform designed to help physicians identify areas where abnormal rhythms originate.

The system creates detailed three-dimensional maps that provide a 360-degree view of the heart, regardless of catheter orientation.

Mike Pederson, Abbott’s senior vice president, electrophysiology, noted that as ablation therapy is increasingly being used for patients with cardiac arrhythmias, “advanced cardiac mapping and imaging tools are essential to help physicians provide the best outcomes for their patients.”