堃博醫療-B(02216.HK):熱蒸汽治療系統(InterVapor®)在中國獲批上市
格隆匯3月21日丨堃博醫療-B(02216.HK)發佈公吿,公司熱蒸汽治療系統InterVapor® (包含熱蒸汽治療設備及一次性使用經支氣管內窺鏡熱蒸汽治療導管,“InterVapor®”)正式獲得中國國家藥品監督管理局(“NMPA”)批准上市,標誌着這款全球唯一的產品正式在中國商業化落地。這是中國及全球首個獲得NMPA批准的用於治療慢性阻塞性肺部疾病(Chronic Obstructive Pulmonary Disease,“COPD”或“慢阻肺”)的熱蒸汽能量消融系統,唯一可以在肺段水平實現靶向分次階段治療的微創介入肺減容產品,為中國龐大的重度和極重度慢阻肺患者帶來介入治療方案,開啟中國呼吸介入治療新紀元。
根據披露,InterVapor®是中國首個獲准“優先審批”的熱蒸汽能量消融系統,屬於臨牀急需且在中國無同品種產品獲准註冊的醫療器械。InterVapor®對於葉間裂完整及不完整患者同樣安全有效,併為晚期慢阻肺患者提供了一種安全、有效、微創的顛覆性解決方案。該公司已擁有熱蒸汽用於肺部治療的獨家專利,具有強大的技術護城河。
InterVapor®可以經支氣管路徑,將熱蒸汽輸送至靶肺段,通過空氣對流方式進行能量傳遞,突破原本肺部含氣量高等能量傳遞阻礙,對嚴重病變的肺段進行治療,顯着改善患者生活質量及肺功能,並提升患者運動耐量,同時保留更多健康肺部組織。
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