Recently, the PulseMagic™ Single-Use Cardiac Pulsed Field Ablation Catheter (PulseMagic™), developed by Shanghai MicroPort EP MedTech Co., Ltd. (referred to as "MicroPort EP") received approval for fast-track registration as innovative medical devices in China.
Pulsed field ablation (PFA) is an innovative ablation technology that uses high-voltage, short-duration electrical pulses to deliver ablation energy. This approach induces irreversible electroporation in cell membranes, resulting in cell apoptosis for targeted tissue ablation. Compared to traditional ablation energy, PFA significantly reduces the risk of complications associated with thermal conduction.
The PulseMagic™ Ablation Catheter, designed for compatibility with pulsed ablation devices, seamlessly integrates with Columbus® 3D EP Navigation System. It provides real-time measurement of the contact force between the catheter tip and the cardiac wall, along with accurate positioning data. These features enable surgeons to optimize catheter placement for improved pulsed field ablation outcomes. PulseMagic™ has successfully completed pre-market clinical trials, with all enrolled patients achieving positive results.
The approval to enter the fast-track registration program will accelerate the market launch of this innovative product, further expanding clinical options for physicians and ensures that more patients benefit from cutting-edge medical technology.