Stereotaxis has published the first clinical results for its MAGiC robotic magnetic navigation catheter, demonstrating strong efficacy and safety in treating cardiac arrhythmias. The study, titled "First In-Human Results of the MAGiC Robotic Magnetic Navigation Radiofrequency Ablation Catheter," was published in the Journal of Interventional Cardiac Electrophysiology and represents the first peer-reviewed literature supporting the technology.
Clinical Study Results
The prospective multi-center, single-arm study evaluated the MAGiC catheter's performance across a broad spectrum of arrhythmias, including atrioventricular nodal reentrant tachycardia, Wolf-Parkinson-White syndrome, atrial fibrillation, atrial flutter, premature ventricular contractions, and ventricular tachycardia in all four chambers of the heart.
The initial analysis included 67 patients and demonstrated an acute efficacy rate of 94%. According to the study authors, this compares favorably to acute efficacy results published in larger ablation registries using other catheters. The average procedure time was 83 minutes skin-to-skin, with a procedure-related adverse event rate of 1.5%, which reflected known risks of radiofrequency ablation in high-risk patients and was not caused by catheter-related malfunction.
Enhanced Performance Characteristics
The study authors, who have combined experience treating over 6,500 robotic procedures with previously available magnetic catheters, noted several improvements with the MAGiC system. These included noticeably improved stability without needing sheaths for catheter support, steady catheter tip temperatures during ablation, and low irrigation rates that benefit patients with poor cardiac and renal function. The authors also observed the potential for more efficient and effective lesions.
Ongoing Development and Launch
Patient enrollment continues with approximately 100 patients enrolled to date, and sustained efficacy assessments are ongoing for up to one year. The study supports Stereotaxis' ongoing launch of the MAGiC catheter across Europe.
"We are delighted to see the strong efficacy and safety profile of MAGiC published in a prestigious journal," said David Fischel, Stereotaxis Chairman and CEO. "This publication supports our ongoing launch of MAGiC across Europe. We appreciate the pioneering electrophysiologists at Copenhagen University Hospital Rigshospitalet and Vilnius University Hospital Santaros Klinikos who made this possible."
Technology Platform
The MAGiC catheter is designed to enhance treatment precision and control during cardiac ablation while maintaining the intrinsic safety advantage of a soft flexible catheter. Stereotaxis' robotic technologies have been used by physicians at over 100 leading hospitals globally to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere.
The study authors concluded that the research demonstrated "good acute efficacy and safety of the MAGiC RMN ablation catheter independent of underlying arrhythmias."
