扩大中风治疗遗产：Terumo Neuro宣布SOFIA™ Flow 88神经血管抽吸导管在欧洲、中东和非洲地区上市-动脉网

Expanding a Stroke Legacy: Terumo Neuro Announces EMEA Commercial Availability of the SOFIA™ Flow 88 Neurovascular Aspiration Catheter

CISION 等信源发布 2025-06-02 15:00

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可切换为仅中文

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Terumo Neuro's

泰尔茂神经

SOFIA

索菲亚

™

Catheter Line is Backed By 10 Years of Proven Clinical Performance

导管线拥有10年经临床验证的性能支持

1-9

and Innovation –

创新 –

The New SOFIA™ Flow 88 Offers Reliable Trackability, Proximal Stability and Vessel-Friendly Flexibility

新型SOFIA™ Flow 88提供了可靠的可追踪性、近端稳定性和对血管友好的灵活性。

PARIS

巴黎

，

June 2, 2025

2025年6月2日

/PRNewswire/ -- Terumo Neuro, a global leader in neurovascular innovation and a wholly owned subsidiary of Terumo Corporation, today announced the commercial availability of the SOFIA™ Flow 88 Neurovascular Aspiration Catheter, expanding the company's stroke portfolio with a new large-bore catheter engineered for reliability, procedural flexibility, and physician control.

/PRNewswire/ -- 全球神经血管创新领域的领导者、泰尔茂集团（Terumo Corporation）全资子公司泰尔茂神经（Terumo Neuro）今日宣布，SOFIA™ Flow 88 神经血管抽吸导管正式投入商业使用。这款全新的大口径导管以其可靠性、手术灵活性和医生操控性进一步扩展了公司的卒中产品组合。

The launch builds on the proven clinical performance and global legacy of the SOFIA™ Catheter line, which has supported more than 500,000 procedures across 170 countries over the past decade. Terumo Neuro is showcasing its complete line of stroke solutions at .

此次发布基于SOFIA™导管系列经过验证的临床表现和全球声誉，该系列在过去十年中已在全球170个国家支持了超过50万例手术。Terumo Neuro正在展示其完整的中风解决方案产品线。

LINNC Paris

LINNC 巴黎

this week at Le Carrousel du Louvre, booth number 8.

本周在卢浮宫卡鲁塞尔，8号展位。

继续阅读

Terumo Neuro SOFIA™ Flow 88 Neurovascular Aspiration Catheter

泰尔茂神经SOFIA™ Flow 88神经血管抽吸导管

Leveraging more than ten years of neurovascular catheter innovation, physician partnerships and proven clinical performance

利用十多年神经血管导管创新、医生合作和经过验证的临床表现

1-9

, the SOFIA™ 88 Neurovascular Aspiration Catheter offers an 0.088-inch inner diameter with proprietary engineering enhancements designed to provide the following benefits:

，SOFIA™ 88 神经血管抽吸导管提供 0.088 英寸的内径，并采用专有工程增强设计，旨在提供以下优势：

Reach with Confidence – Reliable trackability through challenging anatomy via optimized transition zones and a soft, atraumatic distal tip.

自信可达 - 通过优化的过渡区域和柔软、无创伤的远端尖端，在复杂的解剖结构中实现可靠的可追踪性。

Support to Go the Distance – Proximal stability for procedural ease with both short and long sheaths.

支持全程使用——近端稳定性确保短鞘和长鞘操作便捷。

Atraumatic by Design – Flexibility and reinforcement throughout the entire working length to minimize vessel trauma and support smooth navigation.

设计上无创伤 – 全工作长度的柔韧性和增强性能，以减少血管损伤并支持顺畅导航。

Engage the Clot with Confidence - Highly compliant proprietary

自信地参与凝块处理 - 高度兼容的专利技术

SOFIA

索菲亚

tip beyond the marker band expands conforming to the clot.

标记带以外的尖端扩张以适应血栓。

Aspirate with Confidence - Next generation

自信吸液 - 下一代

SOFIA

索菲亚

technology with nitinol braid and coil reinforcement maintains lumen integrity.

具有镍钛诺编织和线圈加固技术，保持管腔完整性。

'As we introduce the SOFIA™ Flow 88 Neurovascular Aspiration Catheter, we are building on a decade of performance that physicians around the world have come to trust,' said

“随着我们推出SOFIA™ Flow 88神经血管抽吸导管，我们正在建立一个十年来的性能基础，全球的医生都已经对其充满信任，”

Carsten Schroeder

卡斯滕·施罗德

, President and CEO of Terumo Neuro. 'This launch is a reflection of our continued investment in neurovascular innovation, made possible through direct collaboration with physicians and our strong R&D and manufacturing capabilities. Together, we are delivering meaningful advancements in stroke care designed to improve outcomes for patients worldwide.'.

神经血管公司总裁兼首席执行官表示：“此次发布反映了我们在神经血管创新方面的持续投资，这得益于与医生的直接合作以及我们强大的研发和制造能力。我们正在共同努力，推动中风护理的有意义的进步，旨在改善全球患者的治疗效果。”

The SOFIA™ 88 Neurovascular Aspiration Catheter is compatible with the SOFIA™ Plus 6F Aspiration Catheter and supports integration into existing aspiration strategies. Clinical evidence from the

SOFIA™ 88 神经血管抽吸导管与 SOFIA™ Plus 6F 抽吸导管兼容，并支持整合到现有的抽吸策略中。临床证据来自

SOFAST

registry & the SESAME trial—evaluating the SOFIA™ Plus 6F as a first-line approach—demonstrated strong results across speed, efficacy, and safety and overall clinical outcomes.

登记册和SESAME试验——评估SOFIA™ Plus 6F作为一线方法——在速度、疗效、安全性以及整体临床结果方面表现出强劲的效果。

The new SOFIA™ 88 Catheter also seamlessly complements the company's broader stroke solution portfolio, offering a fully integrated approach across aspiration, access, retrieval, and navigation:

新型SOFIA™ 88导管还无缝补充了公司更广泛的中风解决方案组合，提供在抽吸、通路、取回和导航方面的完全集成方法：

SOFIA™ and SOFIA™ Plus Aspiration Catheters

SOFIA™ 和 SOFIA™ Plus 抽吸导管

– Renowned for trackability and clinical performance

—— 以其可追踪性和临床表现而闻名

ERIC™ Retrieval Device

ERIC™ 检索装置

– Designed for thrombus control, procedural efficiency, and versatility

- 专为血栓控制、手术效率和多功能性设计

BOBBY™ Balloon Guide Catheter

BOBBY™球囊导引导管

– Reliable flow arrest with streamlined preparation, optimized compatibility and next-generation balloon technology

- 可靠的血流阻断，配备简化的准备流程、优化的兼容性以及下一代球囊技术

WEDGE™ Microcatheter

WEDGE™ 微导管

– A navigation aid that minimizes ledge effect

- 一种减少边缘效应的导航辅助工具

HEADWAY™ Microcatheters

HEADWAY™ 微导管

– Low-profile outer diameter, providing versatility, reliability, and fast access

– 低调的外径设计，提供多功能性、可靠性和快速访问

TRAXCESS™ Guidewires

TRAXCESS™ 导丝

– Soft-tip design for challenging anatomies

软头设计，适用于复杂的解剖结构

References:

参考文献：

Lapergue B, Blanc R, Gory B, et al. Effect of Endovascular Contact Aspiration vs Stent Retriever on Revascularization in Patients with Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER Randomized Clinical Trial. JAMA 2017;318(5):443-452.

Lapergue B, Blanc R, Gory B, 等. 血管内接触抽吸与支架取栓器对急性缺血性卒中伴大血管闭塞患者再灌注的影响：ASTER随机临床试验. JAMA 2017;318(5):443-452.

Turc G., Bhogal P., Fischer U et al. European Stroke Organisation (ESO) – European Society for Minimally Invasive Neurological Therapy (ESMINT) Guidelines on Mechanical Thrombectomy in Acute Ischaemic Stroke Endorsed by Stroke Alliance for

Turc G., Bhogal P., Fischer U 等。欧洲卒中组织（ESO）- 欧洲微创神经治疗学会（ESMINT）关于急性缺血性卒中机械取栓的指南，由卒中联盟支持。

Europe

欧洲

(SAFE). European Stroke Journal 2019;4:6–12.

(SAFE). 欧洲卒中杂志 2019；4：6–12。

Schramm P, Novia P, Papa R, et al. ADAPT technique with ACE68 and ACE64 reperfusion catheters in ischemic stroke treatment: results from the PROMISE study. JNIS 2019;11:226-231.

Schramm P，Novia P，Papa R，等。使用ACE68和ACE64再灌注导管的ADAPT技术在缺血性卒中治疗中的应用：PROMISE研究结果。JNIS 2019；11：226-231。

Turk A, Siddiqui A, Fifi J, et al. Aspiration thrombectomy versus stent retriever thrombectomy as first-line approach for large vessel occlusion (COMPASS): a multicenter, randomized, open label, blinded outcome, non-inferiority trial. Lancet 2019;393:998-1008.

Turk A, Siddiqui A, Fifi J, 等。抽吸取栓术与支架取栓术作为大血管闭塞的一线治疗方法（COMPASS）：一项多中心、随机、开放标签、结果盲评的非劣效性试验。《柳叶刀》2019;393:998-1008。

Brinjikji W, Raz E, De Leacy R, et al. MRS

Brinjikji W，Raz E，De Leacy R，等。MRS

SOFIA

索菲亚

: a multicenter retrospective study for use of

：一项多中心回顾性研究，用于

Sofia

索菲亚

for revascularization of acute ischemic stroke. J NeuroInterventSurg 2021;0:1–5.

用于急性缺血性卒中的血运重建。《神经介入外科杂志》2021年；0:1–5。

Wessel P, Cannarsa G, Carvalho H, et al. Thrombectomy for acute ischemic stroke with the new

韦塞尔·P、坎纳萨·G、卡瓦略·H 等。使用新装置进行急性缺血性卒中的血栓切除术

Sofia

索菲亚

6-French PLUS distal access reperfusion catheter: A single-center experience. The Neuroradiology Journal. 2020;33(1):17-23.

6-French PLUS远端通路再灌注导管：单中心经验。《神经放射学杂志》。2020;33(1):17-23。

Marnat G, Barreau X, Detraz L, et al. First-Line Sofia Aspiration Thrombectomy Approach within the Endovascular Treatment of Ischemic Stroke Multicentric Registry: Efficacy, Safety, and Predictive Factors of Success. AJNR 2019;40:1006-12.

Marnat G, Barreau X, Detraz L, 等。缺血性卒中血管内治疗多中心注册研究中的首选Sofia抽吸取栓方法：疗效、安全性及成功的预测因素。AJNR 2019;40:1006-12。

Möhlenbruch MA, Kabbasch C, Kowoll A, et al. Multicenter experience with the new

Möhlenbruch MA、Kabbasch C、Kowoll A 等。多中心对新产品的经验

SOFIA

索菲亚

Plus catheter as a primary local aspiration catheter for acute stroke thrombectomy. JNIS 2016;9(12):1223-1227.

Plus导管作为急性卒中血栓切除术的主要局部抽吸导管。JNIS 2016；9（12）：1223-1227。

Gandhi D, Chen H, Zaidi S, et al:

甘地D、陈H、扎伊迪S，等：

SOFIA

索菲亚

Aspiration System as first-line Technique (SOFAST): a prospective, multicenter study to assess the efficacy and safety of the 6 French

抽吸系统作为一线技术 (SOFAST)：一项评估6 French系统有效性和安全性的前瞻性、多中心研究

SOFIA

索菲亚

Flow Plus aspiration catheter for endovascular stroke thrombectomy. Journal of NeuroInterventional Surgery. Published Online First:

用于血管内卒中血栓切除术的Flow Plus抽吸导管。《神经介入手术杂志》。在线首发：

27 June 2024

2024年6月27日

. doi: 10.1136/jnis-2024-021811.

Data on file at Terumo Neuro.

Terumo Neuro公司存档的数据。

About Terumo Neuro (Formerly MicroVention, Inc.)

关于Terumo Neuro（前身为MicroVention, Inc.）

We are in business to create and deliver Game-changing Impact™—innovations that redefine what is possible in neurovascular treatment to meaningfully advance both physician practice and patient outcomes. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers more than thirty products for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations.

我们致力于创造和提供颠覆性影响™——革新神经血管治疗领域的创新技术，重新定义可能的界限，从而显著推动医生实践和患者疗效。公司于1997年创立，原名为MicroVention，并于2006年被泰尔茂集团收购，泰尔茂神经目前提供三十多种产品，用于治疗脑动脉瘤、缺血性中风、颈动脉疾病和神经血管畸形。

Headquartered in .

总部位于。

California

加利福尼亚州

, Terumo Neuro products are sold in more than seventy countries through a direct sales organization as well as strategic distribution partnerships. Manufacturing facilities are in

通过直销组织以及战略分销合作伙伴，泰尔茂神经产品销往七十多个国家。制造工厂位于

Aliso Viejo, California

加利福尼亚州，阿利索维耶霍

, and San José,

，以及圣何塞，

Costa Rica

哥斯达黎加

. For more information on Terumo Neuro, please visit

如需更多关于Terumo Neuro的信息，请访问

www.terumoneuro.com

。

About Terumo Corporation

关于泰尔茂公司

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

泰尔茂（TSE:4543）是全球医疗技术的领导者，一百年来一直致力于“通过医疗保健为社会做贡献”。总部位于

Tokyo

东京

and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative 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.

在全球范围内运营，泰尔茂在全球拥有超过30,000名员工，为160多个国家和地区提供创新的医疗解决方案。该公司最初是一家日本温度计制造商，自成立以来一直致力于支持医疗保健事业。如今，其广泛的业务组合涵盖血管介入和心脏外科解决方案、输血和细胞治疗技术，以及日常临床实践中必不可少的医疗产品。

Terumo will further strive to be of value to patients, medical professionals, and society at large..

泰尔茂将进一步努力为患者、医疗专业人士以及整个社会带来价值。

Media Contact:

媒体联系人:

Christine McCullough

克里斯汀·麦卡洛

Global Corporate Communications

全球企业传播

Terumo Neuro

泰尔茂神经

+1 714 206 9800

christine.mccullough@terumoneuro.com

Please refer to the Instruction for Use (IFU) in the specific market/country that you are looking into. Intended for Healthcare Professionals audience Only. Class III CE Marked: 0297.

请查阅您所关注的具体市场/国家的使用说明书 (IFU)。仅适用于医疗专业人士。III 类 CE 认证：0297。

The

SOFIA

索菲亚

Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The

导管适用于一般的血管内使用，包括神经和周围血管。

SOFIA

索菲亚

Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The

导管可用于辅助引入诊断或治疗剂。

SOFIA

索菲亚

Catheter is not intended for use in coronary arteries. Moreover, the

导管不适用于冠状动脉。此外，

SOFIA

索菲亚

Catheter is intended for use in removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neuro vasculatures. Legal Manufacturer: MicroVention Europe S.A.R.L.

导管旨在用于从动脉系统中的选定血管，包括外周和神经血管，去除/抽吸栓子和血栓。法定制造商：MicroVention欧洲有限责任公司。

The ERIC™ Retrieval Device is intended for use in the revascularization of acute ischemic stroke caused by the intracranial occlusive vessels of patients who are not eligible for intravenous tissue plasminogen activator, IV tPA, or who fail IV tPA therapy. Legal Manufacturer: MicroVention Europe S.A.R.L..

ERIC™取回装置用于因颅内闭塞血管导致急性缺血性中风的患者，这些患者不符合静脉注射组织型纤溶酶原激活剂（IV tPA）的条件，或静脉注射tPA治疗失败。合法制造商：MicroVention欧洲有限责任公司。

The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also intended for use as a conduit for retrieval devices.

BOBBY球囊导引导管旨在用于辅助将血管内导管插入并引导至外周和神经血管系统中的选定血管。在这些及其他血管造影过程中，球囊可提供临时的血管阻断。球囊导引导管还可用作取回装置的通道。

Legal Manufacturer: MicroVention, Inc. / EU Authorized Representative: MicroVention Europe S.A.R.L..

法定制造商：MicroVention, Inc. / 欧盟授权代表：MicroVention Europe S.A.R.L.。

The Wedge Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents. Legal Manufacturer: MicroVention, Inc. / EU Authorized Representative: MicroVention Europe S.A.R.L..

Wedge微导管适用于一般的血管内使用，包括外周、冠状动脉和神经血管系统，用于注入诊断剂（如造影剂）和治疗剂。法定制造商：MicroVention公司 / 欧盟授权代表：MicroVention欧洲有限公司。

The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils. Legal Manufacturer: MicroVention, Inc. / EU Authorized Representative: MicroVention Europe S.A.R.L..

Headway微导管用于一般的血管内操作，包括外周、冠状动脉和神经血管系统，适用于注入诊断剂（如造影剂）和治疗剂（如闭塞线圈）。法定制造商：MicroVention公司 / 欧盟授权代表：MicroVention欧洲有限责任公司。

The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. The device is not intended for use in coronary arteries. Legal Manufacturer: MicroVention, Inc.

Traxcess 14 导丝适用于一般的血管内使用，包括神经和外周血管。该导丝可以操控，以促进诊断或治疗导管的选择性放置。本设备不适用于冠状动脉。法定制造商：MicroVention, Inc.

/ EU Authorized Representative: MicroVention Europe S.A.R.L..

/ 欧盟授权代表：MicroVention Europe S.A.R.L.。

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