Stereotaxis, a global leader in surgical robotics for minimally invasive heart procedures, announced that it has secured US FDA approval for its MAGiC Magnetic Interventional Ablation Catheter.

 

“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.”

 

The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures, treating heart arrhythmias with unprecedented precision. Controlled by highly accurate computer-guided magnetic fields, the device allows maneuverability and stability often unattainable with traditional catheters, expanding access to minimally invasive therapy for complex and underserved patients.

 

“Robotic Magnetic Navigation has played a central role in the treatment of complex arrhythmias, and FDA approval of MAGiC is a critical milestone in the advancement of the technology and ensuring its continued positive impact on the care of challenging electrophysiology patients,” said Dr J Peter Weiss, Cardiac Electrophysiologist and Associate Professor of Medicine at Banner University of Arizona Medical Center.

 

Dr J David Burkhardt, Cardiac Electrophysiologist at Texas Cardiac Arrhythmia Institute at St. David's Medical Center, added: “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. We look forward to using MAGiC, and its unique advantages, to continue pioneering the leading edge of electrophysiology.”

 

The MAGiC Magnetic Interventional Ablation Catheter is specifically indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and creating endocardial lesions to treat supraventricular tachycardia in patients with congenital heart disease who face vascular or chamber access challenges due to anatomical abnormalities or prior surgeries.