First Clinical Results Released for MAGiC Catheter Study

Stereotaxis is sharing positive initial study results for its MAGiC Robotic Magnetic Navigation catheter. The data has been published in the Journal of Interventional Cardiac Electrophysiology (“First In‑Human Results of the MAGiC Robotic Magnetic Navigation Radiofrequency Ablation Catheter”).

“We are delighted to see the strong efficacy and safety profile of MAGiC published in a prestigious journal,” Stereotaxis Chairman/CEO David Fischel stated. “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.”

The prospective multi-center, single-arm study used MAGiC to treat patients with a broad spectrum of arrhythmia—atrioventricular nodal reentrant tachycardia, Wolf-Parkinson-White syndrome, atrial fibrillation, atrial flutter, premature ventricular contractions, and ventricular tachycardia—in all four heart chambers. The initial study analysis includes acute efficacy and safety for 67 patients. Patient enrollment is ongoing with approximately 100 patients enrolled to date and continued assessments of sustained efficacy ongoing for up to one year.

MAGiC’s acute efficacy was 94%, and the study authors detail the ways in which this compares favorably to acute efficacy results published in larger ablation registries using other catheters. Procedure time averaged 83 minutes skin-to-skin. A 1.5% procedure-related adverse event rate reflected known risks of RF ablation in high-risk patients and was not caused by any catheter related malfunction. The study authors concluded the trial demonstrated “good acute efficacy and safety of the MAGiC RMN ablation catheter independent of underlying arrhythmias.”

Having together treated more than 6,500 robotic procedures with previously available magnetic catheters, the study authors noted the noticeably improved stability of MAGiC, unneeded sheath use for catheter support and stability, steady catheter tip temperatures during ablation, low irrigation rates benefiting patients with poor cardiac and renal function, and the potential for more efficient and effective lesions.

Stereotaxis’ MAGiC catheter is a robotically-navigated magnetic ablation catheter that performs cardiac ablation procedures to treat arrhythmia. 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’ robots have already been used by physicians at more than 100 hospitals globally to treat over 150,000 patients.

Stereotaxis develops surgical robotics for minimally invasive endovascular intervention. It develops and delivers robotic systems, instruments, and information solutions for the interventional laboratory. Stereotaxis technology has been used to treat more than 150,000 patients throughout the United States, Europe, Asia, and elsewhere.