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

Terumo Neuro's SOFIA Catheter Line is Backed By 10 Years of Proven Clinical Performance^1-9 and Innovation - The New SOFIA Flow 88 Offers Reliable Trackability, Proximal Stability and Vessel-Friendly Flexibility

PARIS, June 2, 2025 /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. 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 LINNC Paris this week at Le Carrousel du Louvre, booth number 8.

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

• Reach with Confidence - Reliable trackability through challenging anatomy via optimized transition zones and a soft, atraumatic distal tip.¹⁰
• Support to Go the Distance - Proximal stability for procedural ease with both short and long sheaths.
• Atraumatic by Design - Flexibility and reinforcement throughout the entire working length to minimize vessel trauma and support smooth navigation.
• Engage the Clot with Confidence - Highly compliant proprietary SOFIA tip beyond the marker band expands conforming to the clot.¹⁰
• Aspirate with Confidence - Next generation SOFIA technology with nitinol braid and coil reinforcement maintains lumen integrity.¹⁰

"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 Carsten Schroeder, 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."

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 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.

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:

• SOFIA and SOFIA Plus Aspiration Catheters - Renowned for trackability and clinical performance
• ERIC Retrieval Device - Designed for thrombus control, procedural efficiency, and versatility
• BOBBY Balloon Guide Catheter - Reliable flow arrest with streamlined preparation, optimized compatibility and next-generation balloon technology
• WEDGE Microcatheter - A navigation aid that minimizes ledge effect
• HEADWAY Microcatheters - Low-profile outer diameter, providing versatility, reliability, and fast access
• TRAXCESS Guidewires - Soft-tip design for challenging anatomies

References:

1. 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.
2. 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 Europe (SAFE). European Stroke Journal 2019;4:6-12.
3. 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.
4. 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.
5. Brinjikji W, Raz E, De Leacy R, et al. MRS SOFIA: a multicenter retrospective study for use of Sofia for revascularization of acute ischemic stroke. J NeuroInterventSurg 2021;0:1-5.
6. Wessel P, Cannarsa G, Carvalho H, et al. Thrombectomy for acute ischemic stroke with the new Sofia 6-French PLUS distal access reperfusion catheter: A single-center experience. The Neuroradiology Journal. 2020;33(1):17-23.
7. 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.
8. Möhlenbruch MA, Kabbasch C, Kowoll A, et al. Multicenter experience with the new SOFIA Plus catheter as a primary local aspiration catheter for acute stroke thrombectomy. JNIS 2016;9(12):1223-1227.
9. Gandhi D, Chen H, Zaidi S, et al: 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. Journal of NeuroInterventional Surgery. Published Online First: 27 June 2024. doi: 10.1136/jnis-2024-021811.
10. Data on file at Terumo Neuro.

About Terumo Neuro (Formerly 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. Headquartered in California, 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 Aliso Viejo, California, and San José, Costa Rica. For more information on Terumo Neuro, please visit www.terumoneuro.com.

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

Media Contact:
Christine McCullough
Global Corporate Communications
Terumo Neuro
[phone]
[e-mail]

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The SOFIA Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The SOFIA Catheter is not intended for use in coronary arteries. Moreover, the SOFIA 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.

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.

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. Legal Manufacturer: MicroVention, Inc. / EU Authorized Representative: 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.

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.

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

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