Global neurovascular firm MicroVention Inc. is sharing clinical trial data that further validates its SOFIA Catheter line's capabilities in treating acute ischemic stroke.

全球神经血管公司MicroVention Inc.正在分享临床试验数据，进一步验证其SOFIA导管线治疗急性缺血性中风的能力。

Published in the Journal of NeuroInterventional Surgery (JNIS), the study—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—assessed the SOFIA Flow Plus Aspiration Catheter (SOFIA 6F) for treating acute ischemic stroke caused by large vessel occlusion.

SOFIA抽吸系统作为一线技术（SOFAST）的研究发表在《神经介入外科杂志》（JNIS）上：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有效性和安全性，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卒中。

This U.S. prospective, multicenter study involved 108 patients and aimed to confirm the catheter’s safety, speed and effectiveness in revascularization. Among the conclusions reached in the trial: .

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。。

A 12-minute median groin puncture to clot contact time and 17-minute median groin puncture to recanalization time.

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。

Seventy-five percent First Pass mTICI≥2b using SOFIA 6F.

使用SOFIA 6F，75%的首次通过mTICI≥2b。

No embolization to new territories and symptomatic intracranial hemorrhage rate within 24 hours.

在24小时内没有栓塞到新界和症状性颅内出血率。

Nearly 67% of patients experienced good functional outcomes at 90 days.

近67%的患者在90天时表现出良好的功能结果。

At the end of the procedure, 97.2%, 85.2%, and 55.6% of patients achieved mTICI≥2b, ≥2c, and 3, respectively.

在手术结束时，分别有97.2%，85.2%和55.6%的患者达到mTICI≥2b，≥2c和3。

With SOFIA 6F first-line aspiration, 87.0%, 79.6%, and 52.8% achieved mTICI≥2b, ≥2c, and 3, respectively.

使用SOFIA 6F一线抽吸，分别有87.0%，79.6%和52.8%的患者达到mTICI≥2b，≥2c和3。

Roughly 18.5% of patients (20/108) crossed over to other devices during the thrombectomy procedure.

大约18.5%的患者（20/108）在血栓切除术过程中转移到其他设备。

“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.

“这项前瞻性、多中心、独立核心实验室判定的SOFAST研究的有效性和安全性数据令人印象深刻，并确立了新的创新标准。手术结束时mTICI≥2b（97.2%）血运重建率高，首次通过后mTICI 2c或更高的比率为70.4%，再通中位时间为17分钟，良好临床结果率为66.7%，是当代血栓切除装置报告的最佳指标之一，”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；；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。。

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-plus articles published globally since it was first introduced more than 10 years ago.The SOFIA Flow Plus Aspiration Catheter is designed for speed to target, clot engagement, kink resistance and a confident first pass, according to MicroVention. .

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10多年前首次推出以来，全球发表了30多篇文章。根据MicroVention的说法，SOFIA Flow Plus抽吸导管设计用于靶向速度，凝块接合，扭结阻力和自信的首次通过。。

“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,” MicroVention President/CEO Carsten Schroeder stated. “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总裁/首席执行官卡斯滕·施罗德（CarstenSchroeder）表示：“SOFAST研究进一步强调，我们的索非亚抽吸导管以其著名的可追踪性，速度和现在进一步证明的临床性能奠定了十多年的标准。”。“我们将继续参与关键的临床研究，如SOFAST，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。”。

From access to revascularization, MicroVention 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提供了一个完全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，楔形微导管，Headwy微导管和Traxces导丝。。

Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve cerebrovascular disease treatment. In 2006, Terumo Corporation acquired MicroVention, allowing both companies to leverage their 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，Terumo Corporation收购了MicroVention，使两家公司能够利用其专有技术，更加专注于治疗脑血管疾病。

Headquartered in California, MicroVention products are sold in more than 70 countries through a direct sales organization alongside strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, Calif., and San José, Costa Rica. .

MicroVention产品总部位于加利福尼亚州，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。。

Tokyo-based Terumo is a global leader in medical technology and employs more than 30,000 associates worldwide to provide medical solutions in more than 160 countries and regions. 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. .

总部位于东京的Terumo是全球医疗技术的领导者，在全球拥有30000多名员工，为160多个国家和地区提供医疗解决方案。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。。