US-based medical technology company Stereotaxis has received China’s National Medical Products Administration (NMPA) approval for Magbot Magnetic Navigation Ablation Catheter.
Magbot is a single-use magnetic saline-irrigated radiofrequency ablation catheter designed and developed by Shanghai MicroPort EP Medtech, Stereotaxis’ collaborator in China.
MicroPort EP is a China-based leading medical device company that has a portfolio of cardiovascular medical devices for the diagnosis and treatment of arrythmias.
Stereotaxis and MicroPort EP previously announced their collaboration in August 2021.
Magbot is indicated for the ablation of drug-resistant persistent atrial fibrillation, atrioventricular nodal re-entrant tachycardia, and atrioventricular re-entrant tachycardia.
The catheter works specifically and in close coordination with Stereotaxis’ robotic systems, including Genesis RMN, and MicroPort EP’s Columbus 3D EP Mapping System.
Magbot comes with advanced design features that significantly improve the efficiency, effectiveness, and safety of robotic magnetic catheter ablation.
The catheter is robotically navigated using low-intensity magnetic fields and can reach areas of the heart that are difficult to access with traditional methods.
Also, it facilitates millimetre-level accuracy, which helps maintain precise positioning and stability in cardiac anatomy.
Stereotaxis chairman and CEO David Fischel said: “We are delighted by Magbot approval in China. 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.”
According to Stereotaxis, the full integration of the Magbot Catheter with the Columbus Mapping System enables real-time location tracking and 3D cardiac modelling.
It allows physicians to precisely record electrocardiographic data and pinpoint lesions for accurate diagnosis and treatment of arrhythmias.
Also, its unique six-electrode design provides visibility of the catheter shaft without the need for fluoroscopy and increases safety during procedures.
MicroPort EP plans to begin the commercialisation of Magbot in China through its existing sales team focused on the electrophysiology community.
MicroPort EP president Yiyong Sun said: “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.
“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.”
