Stereotaxis has announced the publication in the Journal of Interventional Cardiac Electrophysiology of initial clinical results from a first-in-human study utilising the MAGiC catheter—the first peer-reviewed piece of literature supporting the efficacy and safety of the company’s robotically navigated, magnetic radiofrequency (RF) ablation catheter technology, which is designed for the treatment of heart arrhythmias.
“We are delighted to see the strong efficacy and safety profile of MAGiC published in a prestigious journal,” said David Fischel, Stereotaxis’ chairman and chief executive officer (CEO). “This publication supports our ongoing launch of MAGiC across Europe. We appreciate the pioneering electrophysiologists at Copenhagen University Hospital Rigshospitalet [Copenhagen, Denmark] and Vilnius University Hospital Santaros Klinikos [Vilnius, Lithuania] who made this possible.”
The prospective, multicentre, single-arm study used MAGiC to treat patients with a broad spectrum of arrhythmia—atrioventricular nodal re-entrant tachycardia, Wolf-Parkinson-White syndrome, atrial fibrillation (AF), atrial flutter, premature ventricular contractions, and ventricular tachycardia (VT)—in all four chambers of the heart. The initial analysis of the study includes acute efficacy and safety for 67 patients. Patient enrolment is underway with approximately 100 patients enrolled to date and continued assessments of sustained efficacy ongoing for up to one year.
Acute efficacy of MAGiC in this study was 94%, a Stereotaxis press release notes. The study authors detail how this compares favourably to acute efficacy results published in larger ablation registries using other catheters. Procedure time averaged 83 minutes skin-to-skin, while a procedure-related adverse event rate of 1.5% reflected known risks of RF ablation in high-risk patients and was not caused by any catheter-related malfunction, according to the company. The authors concluded that the study demonstrated “good acute efficacy and safety of the MAGiC RMN [robotic magnetic navigation] ablation catheter independent of underlying arrhythmias”.
The authors of the study—with combined experience treating patients across more than 6,500 robotic procedures with previously available magnetic catheters—highlighted the noticeably improved stability of MAGiC, with examples including not needing to use sheaths for catheter support and stability; steady catheter tip temperatures during ablation; low irrigation rates benefitting patients with poor cardiac and renal function; and the potential for more efficient and effective lesions.
Stereotaxis claims in its recent release that its robotic technologies are at the forefront of efforts to advance robotics in minimally invasive endovascular surgeries—and its robots have already been used by physicians at over 100 leading hospitals globally to treat more than 150,000 patients.
