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COLORADO SPRINGS, Colo. & ALISO VIEJO, Calif.--(BUSINESS WIRE)--MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, today announced the recently published results of the CLinical EValuation of WEB 17 Device in Intracranial Aneurysms (CLEVER): One Year Effectiveness Results for Ruptured and Unruptured Aneurysms.
科罗拉多州科罗拉多斯普林斯(COLORADO SPRINGS,Colo.)和加利福尼亚州阿利索·维乔(ALISO VIEJO,California)——(商业新闻短讯)——全球神经血管公司、Terumo Corporation的全资子公司MicroVention,Inc.今天宣布了最近公布的WEB 17装置在颅内动脉瘤(CLEER)中的临床评估结果:破裂和未破裂动脉瘤的一年有效性结果。
The CLEVER study was a multicenter, prospective study evaluating the WEB 17 system in ruptured and unruptured aneurysms to understand the safety and effectiveness of the newest and smallest WEB system..
这项聪明的研究是一项多中心前瞻性研究,评估了破裂和未破裂动脉瘤中的WEB 17系统,以了解最新和最小的WEB系统的安全性和有效性。。
The study comprised of 163 patients across 17 European centers with results concluding that WEB 17 is just as safe and effective as previous WEB generations with a low complication rate and no rebleeds at 30 days and one year. The adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion) at one year follow up.
这项研究由17个欧洲中心的163名患者组成,结果表明,WEB 17与前几代WEB一样安全有效,并发症发生率低,在30天和一年内没有再出血。。
The results of the CLEVER study demonstrate that the WEB 17 system maintains the same efficacy as previous generations of WEB. The WEB is the most well studied intrasaccular device available in the marketplace today, with 7 good clinical practice (GCP) studies and over 200 peer-reviewed publications.
聪明的研究结果表明,WEB 17系统保持了与前几代WEB相同的功效。网络是当今市场上研究最深入的囊内装置,有7项良好临床实践(GCP)研究和200多篇同行评审出版物。
The WEB™ Embolization System is first-in-class intrasaccular technology offering a single-device solution for wide-neck bifurcation aneurysms. The intrasaccular embolization system minimizes the need for a dual antiplatelet regimen required for intraluminal therapies..
WEB™栓塞系统是一流的囊内技术,为宽颈分叉动脉瘤提供单一设备解决方案。囊内栓塞系统最大程度地减少了腔内治疗所需的双重抗血小板方案的需要。。
MicroVention is also celebrating the five-year anniversary of WEB in the US, showcasing this product and its entire line of innovative medical device products at this year’s Society of NeuroInterventional Surgery (SNIS 2024) in Colorado Springs this week, booth number 521.
MicroVention也在庆祝WEB在美国成立五周年,本周在科罗拉多州斯普林斯市举行的今年的神经介入外科学会(SNIS 2024)上展示了该产品及其全系列创新医疗器械产品,展位号为521。
Prof. Laurent Spelle, a contributor from the CLEVER study made the following comments about the WEB technology and the clinical data supporting it: “One-year angiographic results of CLEVER show excellent complete occlusion rates at one year in the population of wide-neck bifurcation aneurysms treated with WEB 17,” said Prof.
来自CLEER研究的贡献者劳伦特·斯佩尔教授对网络技术和支持它的临床数据发表了以下评论:“CLEER的一年血管造影结果显示,在用WEB 17治疗的宽颈分叉动脉瘤人群中,一年内完全闭塞率很高。”。
Laurent Spelle, Professor & Chairman at NEURI Brain Vascular Center, Bicêtre Hospital, APHP, Paris-Saclay University..
劳伦特·斯佩尔(LaurentSpelle),巴黎萨克莱大学APHP比切特医院神经脑血管中心教授兼主席。。
Dr. Adam Arthur, Principal Investigator for the WEB-IT Trial, which was the US IDE study to support WEB PMA approval in the US, also commented: “WEB has changed my practice and set a new standard for safety in the treatment of cerebral aneurysms,” said Dr. Adam Arthur, James T Robertson Professor and Chair at The University of Tennessee Health Science Center..
WEB-IT试验的首席研究员亚当·阿瑟博士(AdamArthur)也评论道:“WEB改变了我的做法,为治疗脑动脉瘤的安全性制定了新的标准,”田纳西大学健康科学中心(University of Tennessee Health Science Center)的詹姆斯·T·罗伯逊(JamesT Robertson)教授亚当·阿瑟(AdamArthur)博士表示。。
“MicroVention’s WEB Aneurysm Embolization System is now the most studied intrasaccular device available today, underscoring our commitment to physicians and patients alike to provide innovative, advanced medical device technology coupled with long-term safety and effectiveness,” said Carsten Schroeder, President and CEO, MicroVention, Inc.
MicroVention公司总裁兼首席执行官卡斯滕·施罗德(CarstenSchroeder)表示:“MicroVention的网络动脉瘤栓塞系统是目前研究最多的囊内装置,强调了我们对医生和患者的承诺,即提供创新的先进医疗设备技术,并具有长期的安全性和有效性。”。
“With over 10,000 units sold in the United States, WEB advances treatment of wide-neck bifurcation aneurysms with one intrasaccular device – clinically proven one and done treatment. We will continue to work side-by-side with leading physicians around the world to identify the evolving needs in patient care, and then transform those insights into innovative technologies that help to save patient lives.”.
“WEB在美国销售了10000多个单位,通过一个囊内装置(经临床验证的一个装置并完成了治疗)推进了宽颈分叉动脉瘤的治疗。我们将继续与世界各地的顶尖医生并肩工作,以确定患者护理中不断变化的需求,然后将这些见解转化为有助于挽救患者生命的创新技术。”。
About the WEB Device:
关于WEB设备:
US Indications for use: The WEB Aneurysm Embolization System is indicated for use at the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex for the endovascular treatment of adult patients with saccular, wide neck bifurcation intracranial aneurysms with dome diameter from 3 mm to 10 mm and either neck size 4 mm or greater or the dome-to-neck ratio is greater than 1 and less than 2..
美国使用适应症:WEB动脉瘤栓塞系统适用于大脑中动脉(MCA)分叉处,颈内动脉(ICA)末端,前交通动脉(AComm)复合体或基底动脉顶点,用于血管内治疗成年患者的囊状,宽颈分叉颅内动脉瘤,其圆顶直径为3毫米至10毫米,颈部大小为4毫米或更大,或圆顶颈比大于1且小于2。。
CE Mark Indication: The WEB Aneurysm Embolization System is intended for the endovascular embolization of ruptured and unruptured intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae (AVF). The WEB Aneurysm Embolization System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation.
CE标志适应症:WEB动脉瘤栓塞系统用于破裂和未破裂的颅内动脉瘤和其他神经血管异常(如动静脉瘘(AVF))的血管内栓塞。WEB动脉瘤栓塞系统还用于神经血管系统内血管的血管闭塞,以永久性阻断动脉瘤或其他血管畸形的血流。
The CLEVER study was conducted in the European Union.
这项聪明的研究是在欧盟进行的。
Data Reported is based on indications of the countries studied.
报告的数据基于所研究国家的迹象。
About MicroVention, Inc.
关于MicroVention,Inc。
Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, Japan, acquired MicroVention into their family of Companies. Terumo’s acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases.
MicroVention成立于1997年,开发和销售能够或显着改善脑血管疾病治疗的医疗设备。2006年,总部位于日本东京的全球大型医疗器械公司Terumo Corporation收购了MicroVention旗下的家族企业。Terumo收购MicroVention使两家公司能够利用其独特的专有技术,更加专注于治疗脑血管疾病。
Headquartered in California, MicroVention products are today sold in more than seventy countries through a direct sales organization alongside strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, California and San José, Costa Rica. For more information on MicroVention, please visit www.microvention.com..
总部位于加利福尼亚州的MicroVention产品今天通过直销组织和战略分销合作伙伴关系在70多个国家销售。制造工厂位于加利福尼亚州的Aliso Viejo和哥斯达黎加的圣何塞。有关MicroVention的更多信息,请访问www.MicroVention.com。。
About Terumo Corporation
关于Terumo Corporation
Terumo (TSE:4543) is a global leader in medical technology and has been committed to 'Contributing to Society through Healthcare' for one hundred years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions.
Terumo(东京证交所代码:4543)是全球医疗技术的领导者,100年来一直致力于“通过医疗保健为社会做出贡献”。Terumo总部位于东京,在全球运营,在全球拥有30000多名员工,为160多个国家和地区提供创新的医疗解决方案。
The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice.
该公司最初是一家日本温度计制造商,此后一直支持医疗保健。现在,其广泛的业务组合包括血管介入和心脏外科解决方案、输血和细胞治疗技术,以及日常临床实践所必需的医疗产品。
Terumo will further strive to be of value to patients, medical professionals, and society at large..
Terumo将进一步努力为患者、医疗专业人员和整个社会创造价值。。