Stereotaxis has today announced that it has obtained US Food and Drug Administration (FDA) approval for the Magic magnetic interventional ablation catheter—a robotically navigated catheter designed to perform cardiac ablation procedures for the treatment of heart arrhythmias.
“US FDA approval of Magic is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology,” said David Fischel, Stereotaxis chairman and chief executive officer (CEO). “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. We want to thank and recognise 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 to expand access to minimally invasive cardiac ablation therapy in complex, underserved patient populations. It is navigated by highly precise, computer-controlled magnetic fields, offering levels of catheter manoeuvrability, precision and stability “often not possible with traditional catheters”, Stereotaxis claims.
“Robotic magnetic navigation has played a central role in the treatment of complex arrhythmias, and US 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,” commented J Peter Weiss (Banner Health, Phoenix, USA).
“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,” added J David Burkhardt (Texas Cardiac Arrhythmia Institute, Austin, USA). “We look forward to using Magic, and its unique advantages, to continue pioneering the leading edge of electrophysiology.”
According to Stereotaxis, the Magic magnetic interventional ablation catheter is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and for the creation of endocardial lesions to treat supraventricular tachycardias 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.
