Stereotaxis (NYSE:STXS) announced the publication of initial clinical results using its MAGiC robotic magnetic navigation catheter.
The results, published in the Journal of Interventional Cardiac Electrophysiology, mark the first peer-reviewed literature supporting the efficacy and safety of MAGiC.
MAGiC, a robotically navigated magnetic ablation catheter, performs minimally invasive cardiac radiofrequency (RF) ablation procedures. It incorporates design features meant to enhance patient safety, procedural effectiveness and efficacy and the physician experience. Stereotaxis won CE mark for the catheter in January and submitted it to the FDA in March.
The prospective, multi-center, single-arm study used MAGiC to treat patients with a range of arrhythmias. These include atrioventricular nodal reentrant tachycardia, Wolf-Parkinson-White syndrome, atrial fibrillation, atrial flutter, premature ventricular contractions, and ventricular tachycardia, occurring in all four chambers of the heart.
Initial analysis from investigators included acute efficacy and safety for 67 patients. Patient enrollment remains ongoing, with approximately 100 subjects enrolled to date. Investigators plan to assess efficacy for up to one year.
Findings included 94% acute efficacy in the procedure, which took 83 minutes skin-to-skin, on average. Investigators reported a procedure-related adverse event rate of 1.5%, reflecting known risks of RF ablation in high-risk patients. Stereotaxis said no catheter-related malfunction caused adverse events.
“We are delighted to see the strong efficacy and safety profile of MAGiC published in a prestigious journal. This publication supports our ongoing launch of MAGiC across Europe,” said David Fischel, Stereotaxis chair and CEO. “We appreciate the pioneering electrophysiologists at Copenhagen University Hospital Rigshospitalet and Vilnius University Hospital Santaros Klinikos who made this possible.”
