Stereotaxis (NYSE:STXS) announced today that it submitted its MAGiC catheter for CE mark approval in Europe.
The St. Louis-based company designed MAGiC as a robotically navigated, magnetic interventional ablation catheter for minimally invasive cardiac ablation procedures.
Used in conjunction with Stereotaxis’ robotic systems, the catheter provides precision, stability and flexibility when diagnosing and treating cardiac arrhythmias, according to a news release. The catheter was developed in collaboration with Osypka, a German medical device company that pioneered the development of radiofrequency ablation for cardiac arrhythmias.
MAGiC was designed to incorporate a wide array of features 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,” Dr. Sabine Ernst, Cardiologist at Royal Brompton & Harefield Hospitals and Professor of Practice in Cardiology at Imperial College London, said in the release. “I believe MAGiC will be a significant leap forward in clinical care for my patients and improved robotic performance.”
Stereotaxis said MAGiC represents the first in a series of interventional devices being developed by the company, serving as a platform for future innovations. The company seeks to make the catheter commercially available for robotic electrophysiology practices in Europe after the receipt of CE mark as early as the end of the year. Separately, the company is working on the submission of an application to the FDA to begin a prospective investigational device exemption trial in the U.S.
“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,” Stereotaxis Chair and CEO David Fischel said. “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.”