Stereotaxis Receives FDA Clearance for First Robotically Navigated High-Density EP Mapping Catheter

Stereotaxis has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MAGiC Sweep™ catheter. 

This marks a major step forward in the field of electrophysiology (EP), as MAGiC Sweep is the first catheter to combine high-density cardiac mapping with robotic navigation.

High-density mapping has become a key component in cardiac ablation, allowing clinicians to better identify the origin of arrhythmias with greater precision and detail. 

The integration of this capability with robotic control is intended to improve both the efficiency and effectiveness of procedures used to treat complex heart rhythm disorders.

High-density mapping: With 20 electrodes, the catheter enables rapid and detailed electroanatomical mapping of the heart.

Precision and extended reach: The catheter integrates seamlessly with Stereotaxis’ robotic systems, allowing it to reach difficult anatomical areas with high accuracy.

Patient safety: Designed with an atraumatic shaft to minimise the risk of tissue damage during procedures.

Improved anatomical accuracy: Its flexible structure avoids distortion of heart anatomy that can occur with rigid catheters, contributing to more accurate mapping.

Optimised workflow: MAGiC Sweep supports enhanced robotic workflows and can be used alongside emerging automation algorithms for mapping.

This FDA clearance is Stereotaxis’ first for an interventional catheter in nearly two decades and represents the company’s renewed focus on expanding its portfolio of robotically navigated devices. The introduction of MAGiC Sweep is part of a broader innovation strategy aimed at transforming interventional cardiology and endovascular care.