Stereotaxis has received US Food and Drug Administration (FDA) approval for its MAGiC Magnetic Interventional Ablation Catheter for treating complex heart rhythm disorders.
David Fischel, Chairman and CEO of Stereotaxis, stated the approval ensures the benefits of Robotic Magnetic Navigation can reach patients with challenging arrhythmias and provides a foundation for continued technological progress.
The MAGiC catheter is a robotically-navigated device designed to perform cardiac ablation to treat arrhythmias. It is specifically intended to expand treatment access for underserved patient populations with complex anatomical challenges, such as those with congenital heart disease. The catheter is guided by computer-controlled magnetic fields, offering superior maneuverability, precision, and stability compared to traditional manual catheters.
Dr. J. David Burkhardt of the Texas Cardiac Arrhythmia Institute emphasized the catheter’s role in offering safe, effective therapy to previously underserved patients, highlighting its unique advantages for pioneering electrophysiology care.
The FDA has indicated the MAGiC catheter for cardiac mapping, diagnostic pacing, and creating lesions to treat specific supraventricular tachycardias in patients where conventional catheter access is limited due to anatomic abnormalities or prior surgeries.
Following the news of the approval, the company’s stock was up by 12.7% at market open on 6 January, compared to the market close on the previous day.
