Stereotaxis seeks approval for new cardiac catheter

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The MAGiC catheter represents a significant development in the field of minimally invasive cardiac ablation treatments. It is a robotically navigated magnetic ablation catheter that benefits from the company’s extensive history of over 100,000 procedures with existing robotic technology. The new catheter aims to improve patient safety, procedural efficacy, and the overall experience for physicians.

Initial human trials began earlier this year as part of a prospective multi-center study. The initial results from the first 20 procedures have been documented for publication, showing a 100% acute efficacy rate and no reported adverse events. These findings were included in the submissions for regulatory approval.

The submissions for the CE Mark in Europe and the PMA Supplement in the United States represent the culmination of a comprehensive process involving design, development, manufacturing, and testing. The MAGiC catheter is the first in a series of interventional devices that Stereotaxis is developing, serving as a foundation for future innovations in the field.

David Fischel, Chairman and CEO of Stereotaxis, expressed optimism about the milestone, stating the company’s eagerness to collaborate with the regulatory agencies during their review process. The goal is to make the benefits of the MAGiC catheter accessible to patients and physicians soon.

Stereotaxis has a long-standing reputation as a pioneer in the field of surgical robotics, dedicated to enhancing the precision, safety, and accessibility of minimally invasive therapies. The company’s technology has been utilized in treating patients across various global regions.

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