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堃博醫療-B(02216.HK):核心產品BroncAblate®智衡®肺部射頻消融系統主機在中國獲批上市

格隆匯6月23日丨堃博醫療-B(02216.HK)公告,董事會欣然宣佈,繼BroncAblate®智衡®一次性使用肺部射頻消融導管(國械注準20253010767)(下稱"BroncAblate®智衡®導管")在中國獲批上市後(詳情請見本公司日期爲2025年4月二11日的公告),本公司的核心產品,自主研發的BroncAblate®智衡®肺部射頻消融系統主機部分(國械注準20253011204)(下稱"BroncAblate®智衡®主機")正式獲得中國國家藥品監督管理局(NMPA)批準上市。至此,BroncAblate®智衡®肺部射頻消融系統這款全球首款經自然腔道(支氣管)射頻消融肺癌治療器械正式進入商業化進程。

BroncAblate®智衡®主機結合BroncAblate®智衡®導管,爲全球首款通過大規模、高質量臨牀研究確證的經自然腔道肺癌射頻消融介入治療器械。BroncAblate®智衡®主機能夠實時監控消融區域靶組織溫度、阻抗等狀態,消融進程同步可視化,直觀把控治療過程,同時可實現智能調節輸出功率,射頻能量輸出穩定、可控,滿足病竈消融所需,精準覆蓋病竈範圍,最終實現患者以更小損傷、更少併發症,獲得更佳的消融療效。

BroncAblate®智衡®導管接入BroncAblate®智衡®主機,先端通過鹽水灌注有效降低阻抗,經自然腔道(支氣管)將射頻能量精準穩定送達肺部腫瘤病竈中心,通過射頻消融滅活腫瘤組織,帶來創傷更小、獲益更佳的肺部腫瘤精準靶向超微創介入療法,成功填補該領域的全球空白。

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