百心安-B(02185.HK):Iberis®多電極腎動脈射頻消融系統(RDN)有望於海南先行區獲批用於臨牀急需
格隆匯11月18日丨百心安-B(02185.HK)發佈公吿,公司的Iberis®多電極腎動脈射頻消融系統(RDN)產品已通過瑞金海南醫院倫理委員會審批,即將向海南省藥品監督管理局及海南省衞生健康委員會申請正式准入並用於臨牀急需。
RDN技術將為無法通過高血壓藥物治療有效控制血壓的患者帶來新的希望,並有望實現長久穩定且24小時不間斷的血壓控制,減少藥物使用量,打破了患者只能依賴藥物降壓的困境。百心安的RDN產品於2016年獲得CE認證在歐盟上市,在本次申請過程中,產品的多電極環向消融、能夠進入腎動脈分支進行消融、擁有橈動脈及股動脈兩種入路選擇等優點得到了專家評審委員會的一致認可。
如最終申請成功,該產品將在海南博鰲先行區獲批用於臨牀急需。此舉一方面有望幫助公司更早實現產品營收;同時公司希望以此為契機,在海南博鰲打造RDN手術培訓中心,提前開展手術培訓及患者教育。本次申請對於公司RDN產品有着重要的戰略意義。
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