Abbott receives CE Mark approval for cardiac mapping platform

3 November 2020 (Last Updated November 3rd, 2020 11:00)

Abbott has received CE Mark and approval in Australia for its new cardiac mapping platform, EnSite X EP System, and is set to launch it throughout Europe and Australia.

Abbott receives CE Mark approval for cardiac mapping platform
The system can create 3D model of the patient’s cardiac anatomy in real time. Credit: Jesse Orrico / Unsplash.

Abbott has received CE Mark and approval in Australia for its new cardiac mapping platform, EnSite X EP System, and is set to launch it throughout Europe and Australia.

EnSite X EP System is a novel cardiac mapping system developed with inputs from electrophysiologists portfolio to enhance cardiac ablation procedures.

The system provides an option to navigate the cardiac anatomy in two different ways on a single platform.

It can improve the way physicians deliver ablation therapy when treating abnormal heart rhythms.

With advanced imaging capabilities, the system can create a three-dimensional (3D) model of the patient’s cardiac anatomy in real time. It will enable physicians to spot areas of the heart that need ablation treatment.

Physicians can use traditional impedance monitoring or electromagnetic technology, which helps to precisely locate Abbott’s sensor-enabled catheters during treatment.

Cardiac ablation is a minimally invasive procedure used to treat abnormally fast heartbeats by creating ablations in small areas of heart tissue that is causing the arrhythmia.

IRCCS San Raffaele Hospital, Italy Cardiac Electrophysiology and Arrhythmology Department head professor Paolo Della Bella said: “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 visualisation.

“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.”

Earlier, Abbott secured Food and Drug Administration (FDA) and CE Mark approval for the EnSite LiveView Dynamic Display, which enables data visualisation from the Advisor HD Grid mapping catheter, Sensor Enabled, in real time during cardiac ablation procedures.

In August, Abbott initiated enrolment of participants into the TactiFlex PAF IDE study of its new catheter device for the treatment of paroxysmal atrial fibrillation (PAF).