堃博医疗-B(02216):BroncTarget®肺部靶向去神经射频消融系统进入创新医疗器械特别审查程序

智通财经
Jan 12

智通财经APP讯,堃博医疗-B(02216)发布公告,旗下BroncTarget®肺部靶向去神经射频消融系统(以下简称“BroncTarget®系统”)正式进入中国国家药品监督管理局(“ 国家药监局”)的创新医疗器械特别审查程序(国家药监局公示文件中披露产品名为:“肺部射频消融系统”),标志着该产品在核心技术原创性、临床价值显著性等方面获得国家药监部门的认可。

肺部靶向去神经射频消融(Targeted Lung Denervation,TLD)是一项针对中重度慢性阻塞性肺疾病(慢阻肺,Chronic Obstructive Pulmonary Disease,COPD)的 突破性介入技术。它通过支气管镜将射频能量精准送达神经靶点,旨在从源头上抑制气道异常收缩与黏液高分泌,从而改善咳嗽、咯痰、呼吸困难等症状。该技术与常规药物治疗协同互补的“介入+药物”综合管理方案,尤其为经常规药物治疗后症状仍控制不佳的患者提供了全新的选择方向。BroncTarget®系统创新地采用了环状多电极、可调节圈口、差异化输出射频能量、实时监测调控温度和阻抗、冷盐水智能灌注等设计,保证了射频消融效率和安全性。

目前,BroncTarget®系统的确证性临床试验正在有序开展中,全国28家医院正同步推进受试者招募。

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