Recently, the National Medical Products Administration has approved the registration applications of four innovative products from Beijing Pins Medical Co., Ltd.: the Deep Brain Stimulation Electrode Lead Kit, the Dual-Channel Rechargeable Deep Brain Stimulation Pulse Generator Kit, the Dual-Channel Deep Brain Stimulation Pulse Generator Kit, and the Deep Brain Stimulation Extension Lead Kit.
The above product is the first directional deep brain stimulation product in China. When used with its accessories, it can stimulate the subthalamic nucleus or the medial globus pallidus and is intended for combined treatment of advanced levodopa-responsive Parkinson's disease patients whose symptoms cannot be effectively controlled by medication. Compared with traditional electrodes, the above product provides directional stimulation to specific functional subregions of the target nuclei, while avoiding side effects of deep brain stimulation in cases of slight electrode misplacement, thereby reducing the risk of reoperation for electrode implantation.
The pharmaceuticals supervision and administration department will strengthen the post-market regulation of the aforementioned products to protect patients' safety in using medical devices.
Source: National Medical Products Administration
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