Abbott (NYSE:ABT) announced today that it received CE Mark and Australian approval for its new EnSite X EP system.
EnSite X EP is touted as the only system that allows for navigation of the cardiac anatomy in two different ways through the same lone platform. The new cardiac mapping platform builds upon Abbott’s electrophysiology portfolio with eyes on improving the way physicians deliver ablation therapy in treating abnormal heart rhythms, according to a news release.
Abbott Park, Ill.-based Abbott’s EnSite X EP includes advanced imaging capabilities that allow for the creation of a 3D model of the patient’s cardiac anatomy in real-time so physicians can clearly see what areas of the heart need ablation treatment. They can then choose traditional impedance monitoring or electromagnetic technology, which allows for the precise location of Abbott’s sensor-enabled catheters during treatment.
EnSite X EP, while now cleared in Europe and in Australia, is currently pending FDA 510(k) clearance in the U.S.
“The new EnSite X System will fundamentally change how physicians approach longer, more complex ablation procedures as a result of its improved stability, faster mapping and better model visualization,” IRCCS San Raffaele Hospital (Milan) head of the dept. of cardiac electrophysiology Paolo Della Bella said in the release. “In my first cases with the system, it’s been apparent that the system is an important step forward in terms of technological capabilities and also truly helps improve my clinical analysis by protecting for patient movements.”