November 2, 2020 – Abbott (Abbott Park, IL) has received CE Mark and approval in Australia for its new EnSite X EP System and announced it is launching the system throughout Europe and Australia.
The EnSite X System offers the option to navigate the cardiac anatomy two different ways on one platform.
Abbott says the new cardiac mapping platform builds upon the company’s electrophysiology portfolio and is designed to improve how physicians deliver ablation therapy to treat abnormal heart rhythms.
The EnSite X System has advanced imaging capabilities that allow for the creation of a 3D model of the patient’s cardiac anatomy in real-time, allowing physicians to clearly see areas of the heart that need ablation treatment. Physicians can choose traditional impedance monitoring (using mechanical activity of the heart) or electromagnetic technology, which allows precise location of Abbott’s sensor-enabled catheters during treatment.
The company also recently secured U.S. Food and Drug Administration (FDA) and CE Mark approval for the EnSite LiveView Dynamic Display, which allows data from the Advisor HD Grid mapping catheter, Sensor Enabled to be visualized in real-time during cardiac ablation procedures. The Advisor HD Grid catheter, SE is designed to capture information often missed with traditional mapping catheters. Additionally, physicians use magnetically sensor enabled technology, such as the TactiCath Contact Force Ablation Catheter, Sensor Enabled, for precise location and navigation within the heart.
The EnSite X EP System is currently pending 510(k) clearance from the U.S. Food and Drug Administration.