植入式闭环神经刺激器应用及临床评价浅析OA

Objective:To analyze the regulatory status of clinical evaluation for implantable closed-loop neurostimulators during registration submissions to the U.S.Food and Drug Administration(FDA),aiming to provide insights for the pre-market clinical evaluation of such products in China.Methods:We retrieved data on the clinical applications and mechanisms of implantable closed-loop neurostimulators,reviewed their market approval status in the U.S.,and summarized and analyzed the clinical evaluation pathways and clinical trial designs for medical devices such as closed-loop spinal cord stimulation(CL-SCS)and closed-loop deep brain stimulation(CL-DBS).Results:The U.S.FDA requires closed-loop stimulators to undergo clinical evaluation via the clinical trial pathway.Clinical trial designs should be based on the intended use,closed-loop mechanism,and target population,while appropriately selecting clinical evaluation endpoints,follow-up durations,and sample sizes.Conclusion:By summarizing the design rationales and protocols for pre-market clinical trials of implantable closed-loop neurostimulators under FDA regulation,this study offers valuable insights that can serve as a reference for the regulatory approval of similar products in China.