Stereotaxis (NYSE:STXS) announced the approval of its Magbot magnetic navigation ablation catheter by Chinese regulatory authorities today. This approval comes shortly after the company’s Genesis robotic magnetic navigation (RNM) system received clearance from China’s National Medical Products Administration. Headquartered in St. Louis, Missouri, Stereotaxis is focused on fast-tracking the introduction of its minimally invasive technology in the Chinese market. Back in 2021, the company joined forces with Shanghai-based MicroPort EP to facilitate the distribution and commercialization of their products in China.
The Magbot is a one-time-use, magnetically guided, saline-irrigated radiofrequency (RF) ablation catheter. It is the result of a collaboration between MicroPort EP and Stereotaxis and is designed to be used exclusively with Stereotaxis’ robotic systems, such as Genesis, as well as MicroPort EP’s Columbus 3D EP mapping system.
“We are thrilled about the Chinese approval for the Magbot,” stated David Fischel, chair and CEO of Stereotaxis. “Achieving this milestone highlights our dedication to enhancing global cardiovascular healthcare. Magbot is a significant advancement in robotic navigation, and we eagerly anticipate further collaboration with MicroPort EP to introduce pioneering technologies that enhance electrophysiology and benefit patients globally.”
Further Insight into the Magbot Ablation Catheter
According to the company, Magbot features several advanced characteristics that improve the efficiency, effectiveness, and safety of robotic magnetic catheter ablation. It leverages low-intensity magnetic fields for robotic navigation to access challenging areas within the heart. The system assures precise positioning and stability on cardiac structures with millimeter-scale accuracy.
Its integration with Columbus facilitates real-time position tracking and 3D cardiac modeling, allowing physicians to accurately record electrocardiographic data and precisely identify lesions for diagnosing and treating arrhythmias. The catheter also features a distinct six-electrode design to ensure procedure safety. This feature provides visibility of the catheter shaft eliminating the need for fluoroscopy.
The NMPA has approved Magbot for treating drug-resistant persistent AFib, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia.
MicroPort EP anticipates launching a commercial rollout using its current sales infrastructure in China.
“The Magbot catheter approval is a significant advancement for MicroPort EP in the realm of cardiac electrophysiology, marking a landmark event for robotic navigation technology in China,” commented Dr. Yiyong Sun, president of MicroPort EP. “Our recent technological developments with Stereotaxis present a safer and more exact minimally-invasive treatment solution for patients with complex arrhythmias. We are enthusiastic about its potential to benefit healthcare professionals and patients alike, while also strengthening our partnership with Stereotaxis to propel innovation in electrophysiology.”