Stereotaxis Earns FDA Clearance and Announces U.S. Launch of Genesis Robotic Magnetic Navigation System
“Genesis is a leap forward in Robotic Magnetic Navigation technology,” said
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% 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 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.
This press release includes statements that may constitute "forward-looking" statements usually containing the words "believe”, "estimate”, "project”, "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, continued acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from healthcare reform in
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Source: Stereotaxis, Inc.