Stereotaxis (NYSE:STXS) announced today that it received FDA 510(k) clearance for its Magic Sweep navigation catheter.
The company describes Magic Sweep as the world’s first robotically navigated high-density electrophysiology (EP) mapping catheter. High-density mapping enhances cardiac ablation procedures through more efficient, detailed and precise identification of arrhythmia origin. Stereotaxis says the clearance marks a significant advancement in the technology available to diagnose and treat complex arrhythmia patients.
Equipped with 20 electrodes, Magic Sweep facilitates rapid and detailed electroanatomical mapping of the heart chambers. It integrates seamlessly with Stereotaxis’ robotic systems to enable precise navigation to otherwise difficult-to-reach areas of the heart.
Stereotaxis said it included an atraumatic design, including an atraumatic shaft, to prioritize patient safety. The catheter supports more anatomically accurate maps by avoiding the distension caused by rigid catheters and enables improved robotic procedural workflows, particularly as the company advances algorithms that support automated mapping.
“FDA clearance of Magic Sweep marks a pivotal moment for Stereotaxis as we advance a broad portfolio of differentiated robotically-navigated catheters. 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 David Fischel, Stereotaxis chair and CEO. “This catheter reflects our commitment to significant innovations that advance robotics in electrophysiology and across endovascular interventions.”
The company submitted Magic Sweep to the FDA in March. At the time, it said it expected a broad commercial launch this year.
