Stereotaxis has gained U.S. Food and Drug Administration (FDA) approval for its MAGiC magnetic interventional ablation catheter.

The MAGiC catheter is a robotically-navigated magnetic ablation catheter engineered for cardiac ablation procedures to treat cardiac arrhythmia. It’s designed to expand access to minimally invasive cardiac ablation therapy in complex, underserved patient populations.

The catheter is navigated by precise computer-controlled magnetic fields. According to Stereotaxis, this provides levels of catheter maneuverability, precision, and stability often impossible to achieve with traditional catheters.

“FDA approval of MAGiC is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology. It ensures the benefits of Robotic Magnetic Navigation can support patients with complex and critical heart rhythm disorders, represents a major advance in robotic cardiac ablation technology, and provides a foundation for continued technological and clinical progress,” said David Fischel, Stereotaxis chairman and CEO. “We want to thank and recognize the team members, partners, clinicians and reviewers who made this milestone possible. We look forward to seeing MAGiC serve as a key pillar in our effort to continue making robotics broadly impactful and beneficial in electrophysiology.”

MAGiC is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and for the creation of endocardial lesions to treat supraventricular tachycardia (e.g., macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia) in patients with congenital heart disease in whom vascular or target chamber access by conventional manual catheter navigation is limited due to underlying anatomic abnormalities and/or previous surgical interventions.

“The MAGiC catheter is an important innovation in the robotic treatment of arrythmias, and will support our efforts to offer safe and effective therapy to otherwise underserved patients,” said Dr. J. David Burkhardt, Cardiac Electrophysiologist, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. “We look forward to using MAGiC, and its unique advantages, to continue pioneering the leading edge of electrophysiology.”

In November, Stereotaxis earned FDA 510(k) clearance for its GenesisX latest-generation robotic system. The GenesisX robot features a compact and efficient design, incorporating magnetic shielding into its structure in place of shielding otherwise installed in operating room walls.