Chinese Regulators Approve Magbot Magnetic Navigation Ablation Catheter

Stereotaxis and Shanghai MicroPort EP Medtech Co. Ltd.’s Magbot Magnetic Navigation Ablation Catheter has received regulatory approval from China’s National Medical Products Administration (NMPA).

“The approval of the Magbot Catheter signifies a major breakthrough for MicroPort EP in cardiac electrophysiology and a significant milestone for robotic navigation technology in China,” MicroPort EP President Dr. Yiyong Sun said. “Our recent technological advances with Stereotaxis offer a safer and more precise minimally-invasive treatment solution for complex arrhythmia patients. We are excited about its potential to benefit physicians and patients alike and to strengthen our partnership with Stereotaxis to drive innovation in electrophysiology.”

The Magbot Catheter is a single-use magnetic saline-irrigated radiofrequency ablation catheter designed and developed by MicroPort EP in collaboration with Stereotaxis. The catheter works exclusively and in tight conjunction with Stereotaxis’ robotic systems, including the recently NMPA-approved Genesis RMN, and MicroPort EP’s Columbus 3D EP Mapping System.

Magbot incorporates advanced design features that substantially enhance the efficiency, effectiveness, and safety of robotic magnetic catheter ablation. Robotically navigated using low-intensity magnetic fields, the Magbot catheter is able to reach areas of the heart otherwise difficult to access with traditional methods and to maintain precise positioning and stability on cardiac anatomy with millimeter-level accuracy. Full integration with Columbus enables real-time location tracking and 3D cardiac modeling, allowing physicians to accurately record electrocardiographic data and pinpoint lesions for precise diagnosis and treatment of arrhythmias. A unique six-electrode design enhances safety during procedures by offering visibility of the catheter shaft without the need for fluoroscopy. Magbot has been approved by NMPA for the ablation of drug-resistant persistent atrial fibrillation, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia.

“We are delighted by Magbot approval in China,” Stereotaxis Chairman/CEO David Fischel stated. “This milestone reflects our commitment to improving global cardiovascular care. Magbot represents a key innovation in robotic navigation, and we look forward to continuing our collaboration with MicroPort EP to pioneer innovative technologies that advance electrophysiology and benefit patients worldwide.”

MicroPort EP will commercially launch Magbot in China through its existing sales team focused on the electrophysiology community. Stereotaxis shares in the proceeds from Magbot adoption. MicroPort EP is one of China’s leading medical device companies with a portfolio of cardiovascular medical devices designed to diagnose and treat arrythmias. Stereotaxis and MicroPort EP previously announced their collaboration in August 2021.

Stereotaxis is a pioneer in surgical robotics for minimally invasive endovascular intervention. It develops and delivers robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat more than 150,000 patients across the United States, Europe, Asia, and elsewhere.