Stereotaxis has today announced the CE Mark submission for its MAGiC™ catheter. The MAGiC catheter is a robotically navigated magnetic interventional ablation catheter for minimally invasive cardiac ablation procedures. Used in conjunction with Stereotaxis’ robotic systems, the MAGiC catheter is designed to provide unparalleled catheter precision, stability and flexibility when diagnosing and treating cardiac arrhythmias.
Building on over 100,000 procedures and nearly twenty years of experience gained from existing robotically navigated ablation catheters, MAGiC has been developed in collaboration with Osypka, a German medical devices company that pioneered the development of radiofrequency ablation of cardiac arrhythmias. MAGiC incorporates various features that are designed to enhance patient safety and efficacy, procedural efficiency, and the physician experience.
“The electrophysiology community has long awaited innovation in robotic catheter technology, and we are very excited by the near-term availability of the MAGiC catheter,” said Prof. Sabine Ernst, Cardiologist at Royal Brompton & Harefield Hospitals and Professor of Practice in Cardiology at Imperial College London. “I believe MAGiC will be a significant leap forward in clinical care for my patients and improved robotic performance.”
CE Mark submission of the MAGiC catheter reflects the culmination of an extensive design, development, manufacturing and testing effort. This catheter is the first in a series of interventional devices being developed by Stereotaxis and serves as a platform for future innovations. Stereotaxis anticipates making the MAGiC catheter commercially available for robotic electrophysiology practices in Europe following receipt of CE Mark as early as year’s end. Stereotaxis separately continues to work toward the submission of an application to the FDA to initiate a prospective IDE trial in the United States.
“We are very pleased to reach this important milestone. This is a seminal event for Stereotaxis as a company and for the physician community that is pioneering the frontiers of robotics in electrophysiology.” said David Fischel, Stereotaxis Chairman and CEO. “Our attention is focused on preparing for commercial launch of the catheter once we receive regulatory clearance. We look forward to the positive impact MAGiC can have on patients, physicians, providers and medical progress.”