Stereotaxis’ Genesis Robotic Magnetic Navigation System Gains FDA Clearance for Cardiac Ablation

March 6, 2020—Stereotaxis, a developer of robotic technologies for the treatment of cardiac arrhythmias, announced it has received FDA 510(k) clearance of the Genesis robotic magnetic navigation (RMN) system for use with magnetic ablation catheters to treat heart rhythm disorders.

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.

The company’s RMN technology provides robotic precision and safety for cardiac ablation. The Genesis device delivers the benefits and reliability of RMN technology in a small, light, flexible architecture. The device uses smaller magnets rotated along their center of mass for increased speed and control. The Genesis system is 70% to 80% faster than its predecessor across a broad range of navigational routines.

According to Stereotaxis, the Genesis RMN system’s significant size reduction is designed to improve patient experience 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 magnets are held on flexible and rugged robotic arms, increasing the potential range of motion of the system and serving as a platform for potential future innovations in other clinical specialties.

Genesis is integrated and available with the company’s Imaging Model S, an X-ray system designed for electrophysiology with digital flat-panel detector technology to support radiation reduction and clear image quality. The combined systems are designed to reduce the cost of acquisition, the ongoing cost of ownership, and the complexity of installing a robotic electrophysiology practice, stated the company.