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ALISO VIEJO, Calif.--(BUSINESS WIRE)--MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, announced the publication of the SOFIA™ Aspiration System as first-line Technique (SOFAST): A prospective, multicenter study to assess the efficacy and safety of the 6 French SOFIA™ Flow Plus Aspiration Catheter for endovascular stroke thrombectomy, recently published in the Journal of NeuroInterventional Surgery (JNIS)..
加利福尼亚州ALISO VIEJO——(商业新闻短讯)——MicroVention,Inc.,一家全球神经血管公司,也是Terumo Corporation的全资子公司,宣布将SOFIA™抽吸系统作为一线技术(SOFAST)发布:一项前瞻性多中心研究,旨在评估6根法国SOFIA™Flow Plus抽吸导管用于血管内卒中血栓切除术的疗效和安全性,最近发表在《神经介入外科杂志》(JNIS)上。。
The SOFAST study assessed the SOFIA™ Flow Plus Aspiration Catheter (SOFIA 6F) for treating acute ischemic stroke caused by large vessel occlusion. This U.S. Prospective, multicenter study involved 108 patients and aimed to confirm the catheter’s safety, speed and effectiveness in revascularization. The long-standing legacy of SOFIA is reinforced by the important data points observed in this publication emphasizing the following:.
SOFAST研究评估了SOFIA™Flow Plus抽吸导管(SOFIA 6F)治疗大血管闭塞引起的急性缺血性中风。这项美国前瞻性多中心研究涉及108名患者,旨在确认导管在血运重建中的安全性,速度和有效性。本出版物中观察到的重要数据点加强了索非亚的长期遗产,强调了以下几点:。
Speed: 12-minute median groin puncture to clot contact time and 17-minute median groin puncture to recanalization time.
速度:腹股沟穿刺至凝块接触时间中位数为12分钟,腹股沟穿刺至再通时间中位数为17分钟。
Efficacy: 75% First Pass mTICI≥2b using SOFIA 6F.
疗效:使用SOFIA 6F,75%首次通过mTICI≥2b。
Safety: 0% embolization to new territories and symptomatic intracranial hemorrhage rate within 24h.
安全性:新界栓塞率为0%,24小时内有症状的颅内出血率为0%。
Clinical Outcomes: 66.7% of patients experienced good functional outcomes at 90 days.
临床结果:66.7%的患者在90天时表现出良好的功能结果。
Please reference the publication for a comprehensive set of data points and outcomes.
有关全面的数据点和结果,请参考出版物。
“The efficacy and safety data from this prospective, multi-center, independent core-lab adjudicated SOFAST study are very impressive and sets a new innovation standard. High rates of mTICI≥2b (97.2%) revascularization at the procedure end, 70.4% rate of mTICI 2c or better after the first pass, median time to recanalization of 17 minutes and 66.7% rate of good clinical outcomes are amongst the very best metrics reported with contemporary thrombectomy devices,” said Dr.
。
Dheeraj Gandhi, Vice Chairman for Academic Affairs; Director, Interventional Neuroradiology; Director, CMIT Center (Center for Metabolic Imaging and Therapeutics); Professor of Radiology, Neurology and Neurosurgery, University of Maryland School of Medicine..
Dheeraj Gandhi,学术事务副主席;介入神经放射学主任;CMIT中心(代谢成像和治疗中心)主任;马里兰大学医学院放射学、神经病学和神经外科教授。。
“The SOFAST Study further underscores that our SOFIA™ Aspiration Catheters have set the standard for more than a decade with its renowned trackability, speed and now with further proven clinical performance,” said Carsten Schroeder, President and CEO, MicroVention, Inc. “We will continue to participate in critical clinical research such as SOFAST, 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.”.
MicroVention,Inc.总裁兼首席执行官卡斯滕·施罗德(CarstenSchroeder)表示:“SOFAST研究进一步强调,我们的SOFIA™抽吸导管以其著名的可追踪性、速度和现已进一步证明的临床性能奠定了十多年的标准。我们将继续参与SOFAST等关键临床研究,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。”。
MicroVention also recently celebrated a decade of legacy innovation commemorating the anniversary of SOFIA™ and SOFIA™ Flow Plus Aspiration Catheters, with more than half a million worldwide procedures performed across 170 countries, and 30+ articles published globally since it was first introduced more than ten years ago.
MicroVention最近还庆祝了SOFIA™和SOFIA™Flow Plus抽吸导管十周年的传统创新,在170个国家进行了50多万次全球手术,自十多年前首次推出以来,全球发表了30多篇文章。
Designed for speed to target, clot engagement, kink resistance and a confident first pass, SOFIA Flow Plus Aspiration Catheters continue to set the pace in treating acute ischemic stroke..
SOFIA Flow Plus抽吸导管专为达到目标的速度,凝块接合,扭结阻力和自信的首次通过而设计,继续为治疗急性缺血性中风奠定了基础。。
From access to revascularization, MicroVention now offers a fully integrated and streamlined portfolio of stroke solutions including SOFIA™, SOFIA™ Flow Plus Aspiration Catheters, as well as ERIC™ Retrieval Device, BOBBY™ Balloon Guide Catheter, WEDGE™ Microcatheter, HEADWAY™ Microcatheters and TRAXCESS™ Guidewires..
从获得血运重建,MicroVention现在提供全面集成和简化的中风解决方案组合,包括SOFIA™、SOFIA™Flow Plus抽吸导管,以及ERIC™检索装置、BOBBY™球囊导管、WEDGE™微导管、Headwy™微导管和TRAXCESS™导丝。。
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 100 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(TSE: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. For more information on Terumo, please visit www.terumo.com/about/profile..
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。有关Terumo的更多信息,请访问www.Terumo.com/about/profile。。
** Editor’s Note: For a Clinical Glossary of Terms, please visit https://www.microvention.com/clinical-education/glossary.
**编者按:有关临床术语表,请访问https://www.microvention.com/clinical-education/glossary.