FDA Clears Stereotaxis' MAGiC Sweep Catheter for High-Density Mapping in Electrophysiology Procedures

Stereotaxis has received FDA clearance for its MAGiC Sweep catheter, the first robotically navigated high-density electrophysiology mapping catheter. This advancement combines high-density mapping with robotics to offer efficient and precise diagnosis and treatment of complex arrhythmias. The catheter features 20 electrodes, atraumatic design, and anatomical accuracy, enabling improved robotic procedural workflow and supporting automated mapping.

Stereotaxis (NYSE: STXS), a pioneer in surgical robotics, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) 510(k) clearance for its MAGiC Sweep™ catheter. This groundbreaking device is the world’s first robotically navigated high-density electrophysiology (EP) mapping catheter, marking a crucial advancement in the field of complex arrhythmia diagnosis and treatment.

The MAGiC Sweep catheter features 20 electrodes for detailed cardiac mapping and integrates seamlessly with Stereotaxis' Robotic Systems. This innovative design offers several advantages, including efficient high-density mapping, extended reach, precision, atraumatic design, and improved anatomical accuracy. These capabilities represent a significant leap forward in the technology available for diagnosing and treating complex arrhythmias.

The FDA clearance of the MAGiC Sweep catheter is a pivotal moment for Stereotaxis, as it marks the company's first clearance for an interventional catheter in nearly 20 years. The device is part of a broader strategy to advance robotically-navigated catheters and enhance the precision and safety of electrophysiology procedures.

Dr. Roderick Tung, Chief of Cardiology and Director of Cardiovascular Clinical Research at The University of Arizona College of Medicine - Phoenix, commented on the significance of the MAGiC Sweep catheter. "Mapping with multi-electrode catheters has taught us so much in both mechanism and therapy for both atrial and ventricular arrhythmias. Remaining limited to only point-by-point mapping has held back the adoption of robotic navigation, as we have become accustomed to seeing human arrhythmias in exquisitely high resolution. We look forward to the positive impact we expect MAGiC Sweep to have on our patients and new possibilities in the field."

Dr. Daniel Cooper, Professor of Medicine and Director of Electrophysiology Lab at Washington University, echoed this sentiment, highlighting the potential of the MAGiC Sweep catheter to support more effective and safe ablation procedures for patients.

David Fischel, Stereotaxis Chairman and CEO, emphasized the company's commitment to innovation. "FDA clearance of MAGiC Sweep marks a pivotal moment for Stereotaxis as we advance a broad portfolio of differentiated robotically-navigated catheters. This catheter reflects our commitment to significant innovations that advance robotics in electrophysiology and across endovascular interventions."

Stereotaxis' mission is to deliver robotic systems, instruments, and information solutions for the interventional laboratory, aiming to enhance patient care with robotic precision and safety. The company's technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere.

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