Shares of Stereotaxis (AMEX:STXS) climbed 12% following the U.S. Food and Drug Administration’s (FDA) 510(k) clearance of its MAGiC Sweep catheter, the first-ever robotically navigated high-density electrophysiology mapping catheter worldwide.
The MAGiC Sweep catheter marks a major technological breakthrough in the diagnosis and treatment of complex arrhythmias. Featuring 20 electrodes, the device enables fast and detailed electroanatomical mapping of heart chambers, enhancing precision and reach by integrating with Stereotaxis’ Robotic Systems.
This approval represents the company’s first interventional catheter clearance from the FDA in nearly 20 years. Designed with patient safety in mind, the catheter’s atraumatic construction helps produce more accurate anatomical maps by minimizing the distortion often caused by rigid catheters.
Dr. Roderick Tung, Chief of Cardiology at The University of Arizona College of Medicine – Phoenix, underscored the importance of this innovation, noting that “point-by-point mapping limitations have previously held back robotic navigation adoption in electrophysiology procedures.”
Dr. Daniel Cooper, Director of the Electrophysiology Lab at Washington University, echoed the sentiment, calling the fusion of high-density mapping with robotic technology “an exciting long-awaited milestone for the community of robotic electrophysiologists and the broader EP field.”
Stereotaxis Chairman and CEO David Fischel described the FDA clearance as a “pivotal moment” for the company, adding that the MAGiC Sweep is just the initial offering in a pipeline of robotically steered interventional devices being developed under their innovation strategy.
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