Castor分支型主动脉覆膜支架完成首例临床植入
2013-04-18
2013年4月8日,微创南宫28ng医疗科技(上海)有限公司(微创集团子公司)“Castor分支型主动脉覆膜支架及输送系统”(以下简称“Castor覆膜支架”)在第二军医大学附属长海医院成功完成第一首例临床植入,这标志着验证Castor覆膜支架腔内治疗胸主动脉夹层临床安全性与有效性的上市前临床研究正式拉开序幕。
随着动脉粥样硬化发病率增加,以主动脉夹层为代表的动脉扩张病在我国已成为常见病。这类疾病存在破裂、肢体内脏缺血和截瘫等严重并发症,致残致死率很高。现有支架型腔内修复术的出现大大降低了手术创伤,逐渐成为主动脉扩张病的主要治疗方法。但是以胸主动脉夹层为代表的主动脉扩张性疾病,如果累及主动脉弓上分支动脉,如左锁骨下动脉(LSA),因其缺乏合适的腔内隔绝移植物,是腔内治疗的相对禁忌。作为微创集团主动脉系列产品最新成员的Castor覆膜支架的出现使主动脉疾病的腔内治疗朝着主动脉弓部的方向迈出了关键性的一步,这也是从事主动脉疾病腔内治疗的临床医生多年来不断探索和寻求突破的治疗领域。
Castor覆膜支架临床试验是世界上首次分支胸主动脉覆膜支架的大规模、前瞻性、多中心的正式临床研究,也是国家“863”、“十二五”规划重大课题。首例临床的成功植入标志着微创南宫28ng的研发能力已达到国际先进水平,对微创集团和微创南宫28ng的未来发展具有重要意义。今明两年,微创南宫28ng还有一系列具有国际先进水平的产品进入国内外临床试验阶段。
注:微创南宫28ng公司的“Castor分支型主动脉覆膜支架完成首例临床植入”相关报道于2013年7月5日发布于Vascular News上。原文如下:
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.
原文链接如下:
http://www.vascularnews.com/vn-latest-news/vascular-news---latest-news/microport-reports-first-in-human-implant-of-branched-stent-graft-for-thoracic-dissection