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["附件3                    "]
["《医疗器械分类目录》子目录12“有源植入器械”相关产品临床评价推荐路径"]
["序号","一级产品类别","二级产品类别","产品描述","预期用途","品名举例","管理类别","免临床评价","临床评价"]
[{"$nulls":8},"同品种","临床试验"]
["01","心脏节律管理设备","01植入式心脏起搏器","通常由植入式脉冲发生器和扭矩扳手组成。通过起搏电极将电脉冲施加在患者心脏的特定部位。","用于治疗慢性心率失常。再同步治疗起搏器还可用于心力衰竭治疗。","植入式心脏起搏器、植入式心脏再同步治疗起搏器","III",null,null,"临床试验"]
[null,null,"02植入式心律转复除颤器","通常由植入式脉冲发生器和扭矩扳手组成。通过检测室性心动过速和颤动，并经由电极向心脏施加心律转复/除颤脉冲对其进行纠正。","用来治疗快速室性心律失常。再同步治疗除颤器还可用于心力衰竭治疗。","植入式心律转复除颤器、植入式再同步治疗心律转复除颤器、植入式皮下心律转复除颤器","III",null,null,"临床试验"]
[null,null,"03 临时起搏器","通常由非植入式脉冲发生器和患者电缆（若使用）组成。","用于心房和心室的体外临时起搏。","临时起搏器、体外起搏器","III",null,"同品种"]
[null,null,"04植入式心脏起搏电极导线","通常由电极导线和附件组成。","与植入式心脏起搏器配合使用，用于治疗慢性心律失常。","植入式心脏起搏电极导线、植入式左室心脏起搏电极导线、植入式心外膜心脏起搏电极导线","III",null,null,"临床试验"]
[null,null,"05植入式心脏除颤电极导线","通常由电极导线和附件组成。","与植入式心律转复除颤器配合使用，用于治疗快速室性心律失常。","植入式心脏除颤电极导线、植入式皮下心脏除颤电极导线","III",null,null,"临床试验"]
[null,null,"06临时起搏电极导线","通常由电极导线和附件组成。","用于心房和心室的临时起搏。","临时心脏起搏电极导线","III",null,"同品种"]
[null,null,"07植入式心脏事件监测设备","通常由监测仪植入体本身和体外附件（若使用）组成。","植入于人体内记录皮下心电图和心律失常事件。","植入式心脏事件监测器、植入式心电事件监测器","III",null,null,"临床试验"]
[null,null,"08植入式封堵工具","通常由硅橡胶材料制成。","用于电极导线终端未使用连接器或植入式脉冲发生器未使用端口的绝缘。","封堵塞、电极导线帽","III",null,"同品种"]
[null,null,"10 起搏系统分析设备","通常由分析仪主机和患者电缆、电缆适配器、无菌延长线组成。","适合在起搏器和除颤器植入过程中用于对起搏电极系统进行分析。","起搏系统分析仪","II",null,"同品种"]
[null,null,"11 心脏节律管理程控设备","通常由显示单元、打印单元、程控单元、软件等组成。","用于询问、程控、显示数据或测试植入式心脏起搏器和植入式心律转复除颤器等心脏节律管理设备。","心脏节律管理设备程控仪、心脏节律管理设备患者程控仪、程控仪","II",null,null,"通常与心脏节律管理设备一起开展临床试验"]
[null,null,"12连接器套筒","通常由接触夹及连接器环形电极组成。","用于连接到电极导线连接器、或者断开连接。","四极连接器套筒","II",null,"同品种"]
["02","神经调控设备","01植入式神经刺激器","通常由植入式脉冲发生器和附件组成。","通过将电脉冲施加在脑部或神经系统的特定部位来治疗帕金森病、控制癫痫、躯干和/或四肢的慢性顽固性疼痛或肠道控制以及排尿控制、肌张力障碍等疾病。","植入式脑深部神经刺激器、植入式脊髓神经刺激器、植入式骶神经刺激器、植入式迷走神经刺激器、植入式可充电脑深部神经刺激器、植入式可充电脊髓神经刺激器、植入式可充电骶神经刺激器、植入式可充电迷走神经刺激器","III",null,null,"临床试验"]
[null,null,"02植入式神经刺激电极","通常由电极导线和附件组成。","与植入式神经刺激器配合使用，用于治疗帕金森病、控制癫痫、躯干和/或四肢的慢性顽固性疼痛或肠道控制以及排尿控制、肌张力障碍等疾病。","植入式脑深部神经刺激电极、植入式脊髓神经刺激电极、植入式骶神经刺激电极、植入式迷走神经刺激电极、植入式脑深部神经刺激延伸导线、植入式脊髓神经刺激延伸导线、植入式骶神经刺激延伸导线、植入式迷走神经刺激延伸导线","III",null,null,"临床试验"]
[null,null,"03测试刺激电极","通常由电极和附件（若使用）组成。","与测试刺激器配合使用，用于临时刺激与测试。","测试神经刺激电极、测试刺激电极、神经刺激测试电极","III",null,null,"通常与植入式神经刺激器及植入式神经刺激电极、测试刺激器一起开展临床试验"]
[null,null,"04神经调控充电设备","通常由充电器、充电线圈、适配器等组成。","用于对特定的可充电植入式脉冲发生器的电池进行充电，以延长可充电植入式脉冲发生器的使用期限。","神经调控体外充电器、体外充电器","III",null,"同品种"]
[null,null,"05植入式电极导线适配工具","通常由适配器、神经刺激器接口插头、转矩扳手组成。","用于连接植入式神经刺激器与适配的植入式延伸导线。","植入式电极导线适配器","III",null,"同品种"]
[null,null,"07测试刺激器","通常由控制单元、输出单元、电源单元组成。","用于在电极导线放置或试验刺激效果期间评估神经刺激系统的功效。","测试神经刺激器、测试刺激器、体外神经刺激器","II",null,null,"通常与植入式神经刺激器及植入式神经刺激电极、测试刺激电极一起开展临床试验"]
[null,null,"08测试延伸导线","通常由延伸导线和附件（若使用）组成。","与测试刺激器、配合使用，用于临时刺激和测试。","测试神经刺激延伸导线、神经刺激系统经皮延伸导线和电缆、多电极测试电缆","II",null,null,"通常与植入式神经刺激器及植入式神经刺激电极、测试刺激器、测试刺激电极一起开展临床试验"]
[null,null,"09神经调控程控设备","通常由程控单元、显示单元、软件等组成。","用于对植入式神经调控设备的询问、程控、显示数据和测试。","神经调控设备程控仪、神经调控设备患者程控仪、程控仪、患者程控仪","II",null,null,"通常与植入式神经刺激器及植入式神经刺激电极一起开展临床试验"]
["03","辅助位听觉设备","01植入式位听觉设备","通常由接收部分、刺激器主体和电极（若有）组成的植入体。","通过对耳蜗内或蜗后听觉传导通路特定部位进行电刺激，或对中耳以及骨传导进行振动来提高或恢复听觉感知。","人工耳蜗植入体","III",null,null,"临床试验"]
[null,null,"02体外声音处理器","通常由言语处理器主机、控制器等组成的体外部分。","与植入式辅助听觉设备体配合使用，将声音转化为电刺激或振动，通过对耳蜗内或蜗后听觉传导通路特定部位进行电刺激，或对中耳以及骨传导进行振动来提高或恢复听觉感知。","人工耳蜗声音处理器","II",null,null,"通常与人工耳蜗植入体一起开展临床试验"]
[null,null,"03辅助位听觉调控设备","通常由主机，连接电缆等组成。","用于调试或测试辅助位听觉设备。","人工耳蜗调机设备、人工耳蜗检测设备","II",null,null,"通常与人工耳蜗植入体一起开展临床试验"]
["04","其他","01植入式心脏收缩力调节设备","通常由植入式脉冲发生器和扭矩扳手组成，通过电极将电脉冲施加在患者心脏的特定部位。","用于心肌收缩力的调节增强。","植入式心脏收缩力调节器","III",null,null,"临床试验"]
[null,null,null,"通常由充电器、充电线圈、适配器等组成。","用于对特定的植入式心脏收缩力调节设备电池进行充电，以延长其使用期限。","心脏收缩力调节设备充电器","III",null,null,"通常与植入式心脏收缩力调节器一起开展临床试验"]
[null,null,null,"通常由显示单元、程控单元、软件等组成。","用于询问、程控、显示数据或测试植入式心脏收缩力调节设备。","心脏收缩力调节设备程控仪","II",null,null,"通常与植入式心脏收缩力调节器一起开展临床试验"]
[null,null,"02植入式循环辅助设备","通常由植入式泵体、电源部分、血管连接和控制器组成。","用于心室循环功能的辅助，代替心脏实现泵血。","植入式左心室辅助装置、植入式右心室辅助装置","III",null,null,"临床试验"]
[null,null,"03植入式药物输注设备","通常由输注泵植入体、鞘内导管、附件等组成。","用于长期输入药物或液体。","植入式药物泵","III",null,null,"临床试验"]