2013年4月8日,微創心脈醫(yī)療科(kē)技(jì )(上海)有(yǒu)限公(gōng)司(微創集團子公(gōng)司)“Castor分(fēn)支型主動脈覆膜支架及輸送系統”(以下簡稱“Castor覆膜支架”)在第二軍醫(yī)大學(xué)附屬長(cháng)海醫(yī)院成功完成第一首例臨床植入,這标志(zhì)着驗證Castor覆膜支架腔内治療胸主動脈夾層臨床安(ān)全性與有(yǒu)效性的上市前臨床研究正式拉開序幕。
随着動脈粥樣硬化發病率增加,以主動脈夾層為(wèi)代表的動脈擴張病在我國(guó)已成為(wèi)常見病。這類疾病存在破裂、肢體(tǐ)内髒缺血和截癱等嚴重并發症,緻殘緻死率很(hěn)高。現有(yǒu)支架型腔内修複術的出現大大降低了手術創傷,逐漸成為(wèi)主動脈擴張病的主要治療方法。但是以胸主動脈夾層為(wèi)代表的主動脈擴張性疾病,如果累及主動脈弓上分(fēn)支動脈,如左鎖骨下動脈(LSA),因其缺乏合适的腔内隔絕移植物(wù),是腔内治療的相對禁忌。作(zuò)為(wèi)微創集團主動脈系列産(chǎn)品最新(xīn)成員的Castor覆膜支架的出現使主動脈疾病的腔内治療朝着主動脈弓部的方向邁出了關鍵性的一步,這也是從事主動脈疾病腔内治療的臨床醫(yī)生多(duō)年來不斷探索和尋求突破的治療領域。
Castor覆膜支架臨床試驗是世界上首次分(fēn)支胸主動脈覆膜支架的大規模、前瞻性、多(duō)中(zhōng)心的正式臨床研究,也是國(guó)家“863”、“十二五”規劃重大課題。首例臨床的成功植入标志(zhì)着微創心脈的研發能(néng)力已達到國(guó)際先進水平,對微創集團和微創心脈的未來發展具(jù)有(yǒu)重要意義。今明兩年,微創心脈還有(yǒu)一系列具(jù)有(yǒu)國(guó)際先進水平的産(chǎn)品進入國(guó)内外臨床試驗階段。
注:微創心脈公(gōng)司的“Castor分(fēn)支型主動脈覆膜支架完成首例臨床植入”相關報道于2013年7月5日發布于Vascular News上。原文(wén)如下:
MicroPort reports first-in-human implant of branched stent graft for thoracic dissection
Fri Jul 5, 2013 14:49 GMT
Vascular specialists at the 2nd Military Medical University-Shanghai Hospital, the 2nd Affiliated Hospital of Harbin Medical University, Jiangsu Province People’s Hospital and Peking University People’s Hospital, China, recently performed the initial implants of a branched stent graft system (Microport).
The use of the system marks, according to a press release, the world’s first-in-human multicentre clinical trial of the Castor branched stent graft, which is expected to be carried out at 11 centres in China.
Jing Zaiping, the study’s primary investigator, according to the release, has successfully used the Castor branched aortic stent graft system in ten cases as of the end of June.
Castor is designed for the entirely endovascular treatment of thoracic dissection encroaching on the left subclavian artery or the original tear located within 15mm distal to the left subclavian artery. According to the company, Castor has an easy-for-use unibody design, including a main body and a left subclavian branch graft. The invention of Castor branched stent-graft system makes it possible to treat a large number of patients with dissection across the aortic arch safely and less invasively.
原文(wén)鏈接如下:
http://www.vascularnews.com/vn-latest-news/vascular-news---latest-news/microport-reports-first-in-human-implant-of-branched-stent-graft-for-thoracic-dissection