Lepu Medical gets NMPA approval for deep brain stimulator system

Lepu Medical Technology (Beijing) Co., Ltd. announced that its subsidiary, Lepu Medical Electronic Instruments Co., Ltd., has received National Medical Products Administration (NMPA) approval for three products. These include a rechargeable implantable deep brain neurostimulator, an implantable deep brain neurostimulation electrode assembly, and an implantable deep brain neurostimulation extension lead set. Classified as Class III medical devices, these products are intended for use with the company's specific neurostimulation electrodes and extension leads.

The approved system is designed for electrical stimulation of the subthalamic nucleus (STN). It aims to treat certain symptoms in patients with late-stage primary Parkinson's disease whose condition is not effectively controlled by medication. Deep Brain Stimulation (DBS) is a neurosurgical procedure that involves implanting electrodes into specific brain regions to deliver continuous or intermittent electrical currents.

This approval is a major achievement for Lepu Medical in neuro-modulation, allowing the company to expand its presence and offer new treatment options for Parkinson's patients. The company highlights that this success will enhance its overall competitiveness in the medical device sector and support future growth. However, Lepu Medical also cautioned investors about potential risks to sales performance due to factors like market promotion, distribution channel development, competitive landscape, and macroeconomic policies.