China’s National Medical Products Administration (NMPA) has granted regulatory approval to the ‘Magbot Magnetic Navigation Ablation Catheter’, a collaborative innovation by Shanghai MicroPort EP Medtech and Stereotaxis, for cardiac ablation procedures.
Designed for single-use, the catheter operates in unison with Stereotaxis’ robotic systems, notably the Genesis RMN, which also received NMPA approval. It is further integrated with MicroPort EP’s Columbus 3D EP mapping system.
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The saline-irrigated radiofrequency ablation catheter’s design significantly improves the safety, efficiency, and effectiveness of robotic magnetic catheter ablation.
Operated robotically with low-intensity magnetic fields, Magbot can access areas of the heart with millimetre-level precision.
Integration with the Columbus system allows for real-time tracking and three-dimensional modelling of the heart, aiding physicians in accurately recording electrocardiographic data and lesion pinpointing for the precise treatment of arrhythmias.
The catheter’s six-electrode design also increases procedural safety by providing visibility of the catheter shaft eliminating the fluoroscopy requirement.
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By GlobalDataMicroPort EP president Dr 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.”
The NMPA has approved the Magbot catheter for the treatment of several heart conditions, including drug-resistant persistent atrial fibrillation and types of tachycardia.
MicroPort EP will spearhead the commercial launch of the catheter in China, leveraging its established sales network within the electrophysiology community, whereas Stereotaxis will share the proceeds from the adoption of the catheter. The partnership was initially announced in August 2021.
In August, Stereotaxis achieved a CE mark in Europe for its minimally invasive endovascular robotic system, GenesisX.
