4 innovative products including implantable deep brain stimulation electrode lead kit approved for marketing
Recently, the China NMPA approved the registration applications for 4 innovative products developed by Beijing PINS Medical Co., Ltd., including implantable deep brain stimulation electrode lead kit, dual channel rechargeable implantable deep brain stimulation pulse generator kit, dual channel implantable deep brain stimulation pulse generator kit and implantable deep brain stimulation extension lead kit.
These products are the first domestically developed directional deep brain stimulation products in China. When used in combination, they can stimulate the subthalamic nucleus or globus pallidus interna, providing a treatment option for patients with advanced Parkinson's disease who experience levodopa-induced dyskinesia and whose symptoms are not adequately managed by medication. Compared to traditional electrodes, these products can provide directional stimulation to specific functional sub-regions of the target nucleus, while minimizing the risk of deep brain stimulation side effects and reducing the need for secondary surgical implantation of electrodes.
The NMPA will strengthen the post-marketing surveillance of these products to protect the safety of medical devices used by patients.