樂普醫療(300003.SZ):切割球囊系統取得產品註冊證
格隆匯 12 月 9日丨樂普醫療(300003.SZ)公佈,公司自主研製的“切割球囊系統”於近日正式獲得國家藥品監督管理局批准的醫療器械註冊證,註冊證編號:國械注準20203030935號,該產品涵蓋血管直徑2.00mm-4.00mm的27個規格產品。切割球囊系統是繼可降解藥物支架(NeoVas)、藥物洗脱球囊(Vesselin)上市後,公司心血管介入治療領域的又一重磅創新產品,也是國內首家獲得NMPA批准註冊上市並填補國內空白的產品。切割球囊系統是一種將顯微外科切割技術與普通球囊擴張機制相結合的球囊。
依據NMPA產品註冊批覆,“適用於患有冠狀動脈血管存在粥樣硬化斑塊需要切割處理的患者”。可能適應症如下:一、單獨使用實現治療目的:1)支架植入後發生再狹窄的患者;2)僅用切割球囊可達到粥樣硬化斑塊擴張切割處理的患者;3)開口病變和原位小血管病變處理。二、與其它器械聯合使用實現治療目的:1)金屬支架植入時,用普通球囊預擴張無法實現預擴目標的患者;2)藥物球囊擴張治療時,為保證藥物的充分釋放,需要藥物球囊充分貼壁,大部分患者需要進行靶病變切割處理;3)可降解支架植入時,為保證支架植入充分貼壁,大部分患者需要進行靶病變切割處理。
“介入無植入”是廣大心血管病患者追求的終身獲益和提升生命品質的健康目標,也是公司近10年來技術迭代創新的追求目標。該產品將進一步提升公司在心血管介入領域的核心競爭力,帶動介入器械板塊營收持續增長,提高創新器械產品收入佔比,將對公司經營發展產生重要影響。
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