Stereotaxis has secured regulatory approval from China's National Medical Products Administration (NMPA) for its Magbot magnetic navigation ablation catheter. This approval, announced on December 9, 2024, marks a significant step in expanding access to minimally invasive cardiac arrhythmia treatment in China. The approval comes shortly after the NMPA cleared Stereotaxis' Genesis robotic magnetic navigation (RNM) system, further solidifying the company's presence in the Chinese market.
Collaboration with MicroPort EP
The Magbot catheter is a single-use, saline-irrigated radiofrequency (RF) ablation catheter designed in collaboration with MicroPort EP, a Shanghai-based firm. Stereotaxis and MicroPort EP established a partnership in 2021 for distribution and commercialization in China. The Magbot system is designed to work exclusively with Stereotaxis' robotic systems, including Genesis, and MicroPort EP's Columbus 3D EP mapping system.
Advanced Features and Benefits
According to Stereotaxis, Magbot incorporates advanced features that enhance the efficiency, effectiveness, and safety of robotic magnetic catheter ablation. The system utilizes low-intensity magnetic fields for robotic navigation, enabling access to difficult-to-reach areas of the heart with millimeter-level accuracy. Integration with the Columbus system allows for real-time location tracking and 3D cardiac modeling, facilitating precise diagnosis and treatment of arrhythmias. The catheter's unique six-electrode design enhances safety by providing visibility of the catheter shaft without the need for fluoroscopy.
Clinical Applications and Commercial Launch
The NMPA has approved Magbot for the ablation of drug-resistant persistent atrial fibrillation (AFib), atrioventricular nodal reentrant tachycardia (AVNRT), and atrioventricular reentrant tachycardia (AVRT). MicroPort EP plans to initiate a commercial launch of Magbot through its existing sales team in China.
"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," said Dr. Yiyong Sun, president of MicroPort EP. "Our recent technological advances with Stereotaxis offer a safer and more precise minimally-invasive treatment solution for complex arrhythmia patients."
David Fischel, chair and CEO of Stereotaxis, 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."
