Stereotaxis Begins First U.S. MAGiC Procedures Following FDA PMA Approval
Stereotaxis completed first U.S. procedures using its FDA-approved MAGiC magnetic ablation catheter for complex congenital heart disease arrhythmias. The initial patient treated via basilic vein approach by Dr. Nathan McConkey has had no recurrence in weeks, underscoring the device’s market potential in complex arrhythmia therapy.
1. FDA Approval and First U.S. Procedures
The MAGiC catheter received FDA PMA approval as the first device specifically cleared for arrhythmia treatment in complex congenital heart disease. Dr. Nathan McConkey at Oregon Health & Science University performed the inaugural U.S. procedure via a basilic vein approach, and the patient has shown no recurrence in the following weeks.
2. Technological Advances and Clinical Impact
MAGiC uses robotically controlled magnetic fields to deliver enhanced stability, contact force and energy precision, enabling ablations in anatomically challenging cases. Physicians report that the catheter allows access and lesion creation that were previously unachievable with manual systems, improving outcomes in underserved congenital arrhythmia patients.
3. Commercial and Market Implications
This U.S. launch marks a key milestone for Stereotaxis, expanding its robotic navigation portfolio and opening new revenue streams in complex electrophysiology. With over 150,000 patients treated globally using its technology, the company is positioned to drive adoption of MAGiC in leading interventional labs.