MicroPort®’s Two Products Approved for Fast-Track Registration as Innovative Medical Device in China

Shanghai, China, 26 November 2024 - Recently, the PulseMagic™ Single-Use Cardiac Pulsed Field Ablation Catheter (PulseMagic™), developed by MicroPort® EverPace, and the Total Wrist System, developed by MicroPort® Orthopedics China, 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™ 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 Total Wrist System features a 3D-printed trabecular bone structure independently developed by MicroPort® Orthopedics China. This system promotes bone ingrowth, enhancing both initial and long-term implant stability. Compared to traditional fusion procedures, its design improves joint mobility, better meeting the requirements of daily activities and increasing post-surgery patient satisfaction. 

The approval to enter the fast-track registration program will accelerate the market launch of these two innovative products, further expanding clinical options for physicians and ensures that more patients benefit from cutting-edge medical technology.

About MicroPort®

Founded in 1998 on the belief that every person has the right to high quality medical treatments, MicroPort® (MicroPort Scientific Corporation; HKEX: 00853) is a global medical devices company. MicroPort® provides solutions across twelve therapeutic areas, including cardiovascular, orthopedics, cardiac rhythm management, electrophysiology, endovascular, neurovascular and surgical robotics among others. For over 26 years, MicroPort® has been breaking barriers and accelerating access to life-changing solutions so that patients everywhere can continue living better and longer lives. With therapeutic solutions that are available in more than 100 countries and over 20,000 hospitals around the world, today, every 5 seconds a patient around the world benefits from a MicroPort® life-changing solution.


More information is available at www.microport.com.