Stereotaxis (NYSE:STXS) received FDA 510(k) clearance of the Genesis RMN System for the robotic navigation of magnetic ablation catheters to treat heart rhythm disorders.
“Genesis is a leap forward in robotic magnetic navigation technology,” David Fischel, chairman and CEO of Stereotaxis, said in a statement. “We are confident Genesis will have a meaningful impact on patients, physicians, and providers in electrophysiology.”
Robotic magnetic navigation introduces the benefits of robotic precision and safety to cardiac ablation, a common minimally invasive procedure to treat arrhythmias. More than 100,000 patients have been treated using Stereotaxis’ RMN technology in more than 100 hospitals around the world. Over 350 scientific publications have documented the technology’s clinical value.
Across a broad range of navigational routines, the Genesis System is 70% to 80% faster than its predecessor. The system’s significant size reduction is designed to improve the patient experience while on the operating table, provide physicians and nurses with greater access to the patient during the procedure, and increase space in the labs for an enhanced work environment.
The Genesis RMN System has FDA clearance to navigate an array of compatible interventional devices broadly within all chambers of the heart and coronary vasculature, and throughout the neuro and peripheral vascular system.
