Stereotaxis has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Magic Sweep catheter—described by the company as the “world’s first” robotically navigated high-density electrophysiology (EP) mapping catheter. Stereotaxis claims in a press release that its Magic Sweep device represents a significant advancement in the technology that is available to diagnose and treat complex arrhythmia patients.
“The development of the first ever robotically navigated high-density mapping catheter is a major milestone for the EP field,” said Roderick Tung (University of Arizona College of Medicine, Phoenix, USA). “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.”
According to Stereotaxis, high-density mapping has “transformed” the EP field, enhancing cardiac ablation procedures by enabling more efficient, detailed and precise identification of the origin of arrhythmias. The combination of high-density mapping with robotics via the Magic Sweep catheter is designed to offer multiple improvements, including:
- Rapid and detailed electroanatomical mapping of the heart chambers
- Extended reach and precise navigation of the catheter to otherwise difficult-to-reach areas of the heart
- An atraumatic catheter shaft designed to prioritise patient safety
- Avoiding the distension caused by rigid catheters via support for more anatomically accurate maps
- Efficient, robotics-enabled procedural workflow
“The ability to combine high-density mapping with robotics is an exciting, long-awaited milestone for the community of robotic electrophysiologists and the broader EP field,” stated Daniel Cooper (Washington University, St Louis, USA). “By helping us efficiently create more accurate and detailed maps of complex arrhythmia, robotic high-density mapping with Magic Sweep supports our efforts to provide the most effective and safe ablation procedures for our patients.”
“US FDA clearance of Magic Sweep marks a pivotal moment for Stereotaxis as we advance a broad portfolio of differentiated robotically navigated catheters,” added Stereotaxis chairman and chief executive officer (CEO) David Fischel. “Magic Sweep is Stereotaxis’ first US 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. This catheter reflects our commitment to significant innovations that advance robotics in EP and across endovascular interventions.”
