Stereotaxis (NYSE:STXS) announced today that its Magbot magnetic navigation ablation catheter received regulatory approval in China.
This nod comes just weeks after the company won approval from China’s National Medical Products Administration for the Genesis robotic magnetic navigation (RNM) system. St. Louis, Missouri-based Stereotaxis aims to accelerate access to its minimally invasive technology in China. In 2021, the company inked a collaboration with MicroPort EP, a Shanghai-based firm, for distribution and commercialization in China.
Magbot is a single-use, magnetic, saline-irrigated radiofrequency (RF) ablation catheter. MicroPort EP designed the system in collaboration with Stereotaxis. The catheter works exclusively and in tight conjunction with Stereotaxis’ robotic systems, including Genesis. It also works with MicroPort EP’s Columbus 3D EP mapping system.
“We are delighted by Magbot approval in China,” said David Fischel, chair and CEO of Stereotaxis. “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.”
More about the Magbot ablation catheter
The company says Magbot incorporates advanced features that enhance the efficiency, effectiveness and safety of robotic magnetic catheter ablation. It uses low-intensity magnetic fields for robotic navigation to reach difficult-to-access areas of the heart. The system maintains precise positioning and stability on cardiac anatomy with millimeter-level accuracy.
Magbot’s integration with Columbus enables real-time location tracking and 3D cardiac modeling. It enables physicians to accurately record electrocardiographic data and pinpoint lesions for precise diagnosis and treatment of arrhythmias. The system has a unique six-electrode design to enhance safety during procedures. This offers visibility of the catheter shaft without the need for fluoroscopy.
NMPA approved Magbot for the ablation of drug-resistant persistent AFib, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia.
MicroPort EP plans to initiate a commercial launch 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. We are excited about its potential to benefit physicians and patients alike and to strengthen our partnership with Stereotaxis to drive innovation in electrophysiology.”
