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SUZHOU, China, Oct. 27, 2023 /PRNewswire/ -- Peijia Medical Limited (Peijia, (9996.HK)), a leading Chinese medical device player in transcatheter structural heart device and neurovascular device, presented its GeminiOne® TEER technology, along with the early clinical experiences of the device at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference.
中国苏州,2023年10月27日/PRNewswire/-北京医疗有限公司(北京,(9996.HK)),中国领先的经导管结构性心脏装置和神经血管装置的医疗器械参与者,介绍了其GeminiOne®TEER技术,以及该装置在第35届经导管心血管治疗(TCT)会议上的早期临床经验。
The session was presented by, Dr. Saibal Kar, MD, Program Director of Cardiology at Los Robles Regional Medical Center and Physician Director of Interventional Cardiology at HCA Healthcare..
会议由Los Robles地区医疗中心心脏病学项目主任Saibal Kar博士和HCA医疗保健介入心脏病学医师主任介绍。。
'GeminiOne® definitely has a unique design…the most important part of the design is the sliding groove which allows longer coaptation length and closed as a smaller implant,' said Dr. Saibal Kar, MD. 'The design of GeminiOne® seems to address some of the MitraClip's shortcomings and hopefully, that it can be available in the U.S.
“GeminiOne®绝对具有独特的设计……设计中最重要的部分是滑动槽,它允许更长的接合长度并作为较小的植入物封闭,”Saibal Kar博士,医学博士说。'GeminiOne®的设计似乎解决了MitraClip的一些缺点,并希望它可以在美国使用。
soon,' commented Professor Clifford Kavinsky, the session's moderator..
会议主持人Clifford Kavinsky教授评论道。。
GeminiOne® is a novel TEER device that is designed to allow a longer coaptation length and minimized SLDA with sustained reduction in mitral regurgitation (MR). The thirty-day results (35 cases) reported no death, major adverse events, or conversion to surgery. Postoperative echo measures showed that 100% of the 35 patients had significant improvements in MR and maintained MR severity at 1+ or below at 30 days..
GeminiOne®是一种新型TEER装置,旨在延长接合长度并最大限度地减少SLDA,持续减少二尖瓣反流(MR)。30天的结果(35例)报告没有死亡,主要不良事件或转为手术。术后回声测量显示35例患者中有100%的MR有显着改善,并且在30天时MR严重程度维持在1+或更低。。
'Right from the beginning, GeminiOne® design focuses on simplified clinical procedure with better performance. We are very encouraged by the early clinical results, and also being confident about the clean IP position of that design,' said Dr. Yi Zhang, Chairman and CEO of Peijia. 'With its intuitive design and promising clinical performance, we believe it will be the pioneering product for Peijia's global footprint.'.
“从一开始,GeminiOne®设计就专注于简化的临床程序,具有更好的性能。Peijia主席兼首席执行官张毅博士说,我们对早期的临床结果非常鼓舞,并且对这种设计的清洁知识产权地位也充满信心凭借其直观的设计和有希望的临床表现,我们相信它将成为Peijia全球足迹的开拓性产品。
GeminiOne® is currently undergoing a multi-center clinical study in China with 20+ enrolling sites. The pivotal study is intended for the treatment of high risk, symptomatic degenerative mitral regurgitation patients. The early feasibility study in the U.S. is expected to commence in 2024.
GeminiOne®目前正在中国进行多中心临床研究,有20多个注册网站。关键研究旨在治疗高风险,有症状的退行性二尖瓣关闭不全患者。美国的早期可行性研究预计将于2024年开始。
About the Company
关于公司
Peijia Medical (9996.HK) was established in 2012 and is headquartered in Suzhou, China. Peijia Medical focuses on the high-growth interventional procedural medical device market in China, and aims to become a world-renowned medical device platform that provides comprehensive treatment solutions for structural heart and neurovascular diseases.
Peijia Medical(9996.HK)成立于2012年,总部设在中国苏州。Peijia Medical专注于中国高增长的介入手术医疗器械市场,旨在成为世界知名的医疗器械平台,为结构性心脏和神经血管疾病提供全面的治疗方案。
The Company now has two generations of TAVR systems and fifteen neurointerventional devices commercialized in China and various innovative product candidates at different stage of development. For more information about Peijia, visit peijiamedical.com/about..
该公司现在拥有两代TAVR系统和十五个在中国商业化的神经介入设备,以及处于不同发展阶段的各种创新产品候选人。有关Peijia的更多信息,请访问peijiamedical.com/about。。
SOURCE Peijia Medical
来源Peijia Medical