Stereotaxis receives FDA clearance for Genesis Robotic Magnetic Navigation system

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Stereotaxis’ Genesis RMN system

Stereotaxis has received US Food and Drug Administration (FDA) 510(k) clearance for the Genesis Robotic Magnetic Navigation (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,” says David Fischel, chairman and CEO of Stereotaxis. “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.”

RMN uses robotics and magnetic fields to navigate a cardiac catheter directly from the tip. RMN introduces the benefits of robotic precision and safety to cardiac ablation, a common minimally invasive procedure to treat arrhythmias, Stereotaxis said in a press release. 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 utilises smaller magnets rotated along their centre-of-mass for increased speed and control. Across a broad range of navigational routines, the Genesis System is 70% to 80% faster than its predecessor, Stereotaxis said.

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.


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