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 performance1-9, 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.