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

According to the company, MAGiC Sweep is the world’s first robotically navigated, high-density electrophysiology (EP) mapping catheter. The technology is used to diagnose and treat complex arrhythmia patients.

High-density mapping can enhance cardiac ablations through more efficient, detailed, and precise identification of arrhythmia origin.

MAGiC Sweep is equipped with 20 electrodes to facilitate rapid, detailed electroanatomical mapping of the heart chambers. It integrates with Stereotaxis’ robotic systems to precisely navigate to otherwise difficult to reach heart areas.

The catheter’s design features an atraumatic shaft and supports more anatomically accurate maps by avoiding distension caused by rigid catheters. It enables improved robotic procedural workflow, especially as the company advances algorithms to support automated mapping.

Dr. Roderick Tung, Chief of Cardiology and Director of Cardiovascular Clinical Research at The University of Arizona College of Medicine – Phoenix said development of the first ever robotically navigated, high-density mapping catheter is a major milestone for the EP field.

“Mapping with multi-electrode catheters has taught us so much in both mechanism and therapy for both atrial and ventricular arrhythmias,” Dr. Tung told the press. “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.”

Stereotaxis chairman and CEO David Fischel said MAGiC Sweep’s FDA clearance is a pivotal moment for the company as it advances a broad portfolio of differentiated, robotically-navigated catheters. The MAGiC ablation catheter received CE mark approval earlier this year.

MAGiC Sweep is Stereotaxis’ first FDA clearance for an interventional catheter in nearly 20 years, but is only the first of multiple robotically-steered interventional devices being advanced as part of our comprehensive innovation strategy,” said Fischel. “This catheter reflects our commitment to significant innovations that advance robotics in electrophysiology and across endovascular interventions.”