You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
佰仁醫療(688198.SH):創新產品流出道單瓣補片全球首次獲批上市
格隆匯 04-12 16:01

格隆匯4月12日丨佰仁醫療(688198.SH)宣佈,近日,經國家藥品監督管理局審查,公司自主研發的創新產品流出道單瓣補片(國械注準20213130224)獲准註冊,這是全球首次批准流出道單瓣補片上市。

該產品以牛的心包組織為原材料,通過脱去其組織內的細胞成分、去除組織免疫原性以及系列組織交聯與抗鈣化改性處理,沿用了公司牛心包生物瓣的部分製造工藝,根據複雜先心病患兒右室流出道及肺動脈瓣膜出生缺陷的病理特性和右心室連接左右肺動脈具有約45度角的解剖結構特點,結合國內複雜先心外科權威專家的臨牀實踐,以獨特的結構設計和縫製工藝,最終研製出帶有無支架牛心包單瓣的跨瓣環補片-流出道單瓣補片(10-26mm),產品適用於從嬰幼兒至成年需要右室流出道修復的複雜先心病患者。作為複雜先心病右室流出道修復用的全球首款帶單瓣植入器械,該產品的註冊填補了人工跨瓣環加寬修復主肺動脈及肺動脈瓣這一領域的空白。

我國人口基數大,出生缺陷導致的先天性心臟病患者較多,現已達200萬。每年出生的嬰兒中先天性心臟病患兒約有15-18萬,長期佔出生缺陷的首位,其中有近5萬患兒為複雜先心病。這些患兒大多數涉及肺動脈瓣出生缺陷,唯有手術根治才能持續生存。流出道單瓣補片就是專用於右室流出道修復的必備產品,其結構優勢在於一個單瓣可代替天然的三葉肺動脈瓣,有效地防止了肺動脈返流;同時使有條件保留部分自體組織的患者實施加寬修復而無需重建右室流出道,修復後的流出道部分自體組織可隨着年齡的增長而加速增長,以致使患兒最終發育成與同齡健康孩子等同的主肺動脈。

Follow us
Find us on Facebook, Twitter , Instagram, and YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
uSMART
Wealth Growth Made Easy
Open Account