Stereotaxis Secures FDA Clearance for MAGiC Sweep Catheter

New magnetic ablation catheter designed to enhance precision and reach in robotic electrophysiology procedures across the U.S.

Stereotaxis’ FDA 510(k) clearance for the MAGiC Sweep™ catheter represents a major leap in the field of cardiac electrophysiology, combining robotic precision with high-density electroanatomical mapping for the first time. Designed to work seamlessly with Stereotaxis’ robotic navigation systems, MAGiC Sweep is equipped with 20 electrodes and offers unprecedented efficiency and accuracy in mapping cardiac arrhythmias. Its flexible, atraumatic design minimizes cardiac wall distortion, allowing for safer navigation and more anatomically accurate maps compared to rigid, manually guided catheters.

In clinical practice, the integration of high-density mapping with robotic systems has long been a sought-after milestone. MAGiC Sweep addresses this gap by enabling precise access to hard-to-reach areas within the heart and streamlining procedural workflow. With automated algorithms in development, this catheter is expected to support advanced mapping techniques, reduce procedure time, and enhance diagnostic capabilities. It empowers electrophysiologists to better localize arrhythmogenic tissue, facilitating more effective and targeted ablation therapies for patients with complex atrial and ventricular arrhythmias.

The clearance of MAGiC Sweep marks Stereotaxis’ first FDA-approved interventional catheter in nearly two decades and sets the stage for a new generation of robotic tools in cardiac care. This innovation is part of a broader portfolio strategy to expand the capabilities of robotic navigation in electrophysiology and beyond. As clinical demand grows for safer, more accurate, and c, MAGiC Sweep positions Stereotaxis to meet that need while shaping the future of precision-guided endovascular interventions worldwide.


MedTech Spectrum's Summary 
 
First-of-Its-Kind Innovation: MAGiC Sweep is the world’s first robotically navigated high-density EP mapping catheter, combining robotic precision with rapid, detailed mapping to advance the diagnosis and treatment of complex arrhythmias.
 
Enhanced Safety and Efficiency: The catheter's atraumatic design and seamless integration with robotic systems improve procedural safety, extend anatomical reach, and enable faster, more accurate electroanatomical mapping.
 
Strategic Milestone for Stereotaxis: This FDA clearance marks a pivotal moment in Stereotaxis' innovation roadmap, signaling a new era of robotically-steered interventional tools aimed at elevating electrophysiology and broader endovascular care.