Clinical Study Validates Efficiencies of Stereotaxis Niobe ES System

Stereotaxis Inc., a developer of robotic technologies for the treatment of cardiac arrhythmias, has reported results of a study conducted at Centre Hospitalier Universitaire (CHU) of Saint-Étienne, France, which validates the advantages of the Niobe ES magnetic navigation system over the Niobe II system in terms of procedure and fluoroscopy times for atrial fibrillation (AF) ablation procedures. The study was published in the International Journal of Cardiology and represents the first comparison study of Stereotaxis’ latest generation remote magnetic navigation system to its predecessor.
 
“Our aim with this study was to quantify the clinical improvements that we have experienced with complex arrhythmia ablations, specifically AF, since upgrading to the Niobe ES system,” said Antoine Da Costa, M.D., Ph.D., chief of the EP Unit at CHU of Saint-Étienne. “We sought to evaluate procedure duration, as well as efficacy and extent of fluoroscopic exposure associated with the Niobe ES system compared to the Niobe II in patients requiring AF ablation. Our results confirmed that the Niobe ES system reduced procedure time and X-ray exposure by a minimum of 30 percent, primarily due to the system’s enhanced responsiveness.”     
 
In the Saint-Étienne study, researchers compared data on 92 consecutive patients treated with the Niobe ES system to 92 consecutive patients treated using the Niobe II system for symptomatic drug-refractory atrial fibrillation. The percentage of circumferential pulmonary vein isolation, as confirmed via spiral catheter recording during ablation, was 100 percent. Procedure time was significantly lower with the Niobe ES system than the Niobe II system (1.9 ± 0.4 vs. 2.7 ± 1h, p < 0.0001), as was X-ray duration (12 ± 4 vs. 15 ± 7 min, p = 0.001).
 
The Electrophysiology Unit (EP) at CHU of Saint-Étienne first implemented Stereotaxis technology in 2009 and installed a second Niobe system in 2015. They are recognized as a national center of excellence, consistently ranked in the top five for interventional cardiology in France, as well as a European center of reference in the treatment of complex arrhythmias. 
 
The Niobe ES system constitutes Stereotaxis’ fourth generation magnetic navigation technology, designed to improve functionality through faster computing hardware, new motion controllers and a more intuitive user interface. By creating a near real-time response to catheter movement commands, the Niobe ES enables an operator to navigate an ablation catheter more quickly, precisely and with little fluoroscopic guidance. The ensuing results can be faster anatomy-specific ablation procedures with significantly less X-ray exposure to the patient and physician.   
 
Stereotaxis develops robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Over 100 issued patents support the Stereotaxis platform. The core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, Japan, Canada, China, and elsewhere.