FDA OKs Stereotaxis’ Genesis Robotic Magnetic Navigation

Stereotaxis, developer of robotic technologies for the treatment of cardiac arrhythmias, has received U.S. Food and Drug Administration (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,” said David Fischel, Chairman and CEO. “We are confident Genesis will have a meaningful impact on patients, physicians, and providers in Electrophysiology. Genesis is a reflection of our commitment to positively transform interventional medicine with robotics.”
 
Tens of millions of individuals worldwide suffer from arrhythmias. When left untreated, certain arrhythmias can significantly increase the risk of stroke, heart failure, and sudden cardiac arrest. Robotic Magnetic Navigation (RMN) 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.
 
The Genesis RMN System builds upon the established benefits and reliability of RMN in an innovative architecture that is faster, smaller, lighter and more flexible. It utilizes smaller magnets rotated along their center-of-mass for increased speed and control. Across a broad range of navigational routines, the Genesis System is 70 percent to 80 percent 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 magnets are held on flexible and rugged robotic arms, increasing the potential range of motion of the system and serving as a platform from which future innovations in other clinical specialties may be possible. 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.
 
Genesis is integrated and available with Stereotaxis Imaging Model S, an x-ray system designed for electrophysiology with modern, 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 installation of a robotic electrophysiology practice. Stereotaxis will serve as the single source for architectural planning, installation, and ongoing servicing and maintenance of the combined technologies, providing a more efficient, responsive, and cost-effective solution.