Terumo Neuro, a global leader in neurovascular innovation and wholly owned subsidiary of Terumo Corporation, announced the commercial availability of the SOFIA Flow 88 Neurovascular Aspiration Catheter in Europe, Middle East, and Africa (EMEA) markets. The launch expands the company's stroke portfolio with a new large-bore catheter engineered for reliability, procedural flexibility, and physician control.
The EMEA 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 showcased its complete line of stroke solutions at LINNC Paris this week at Le Carrousel du Louvre.
Advanced Engineering for Stroke Intervention
Leveraging more than ten years of neurovascular catheter innovation, physician partnerships and proven clinical performance, the SOFIA 88 Neurovascular Aspiration Catheter offers an 0.088-inch inner diameter with proprietary engineering enhancements designed to provide several key benefits:
The catheter features reliable trackability through challenging anatomy via optimized transition zones and a soft, atraumatic distal tip. It provides proximal stability for procedural ease with both short and long sheaths, while offering flexibility and reinforcement throughout the entire working length to minimize vessel trauma and support smooth navigation.
The device includes a highly compliant proprietary SOFIA tip beyond the marker band that expands conforming to the clot, and incorporates next generation SOFIA technology with nitinol braid and coil reinforcement that maintains lumen integrity.
"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."
Clinical Evidence and Integration
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 and 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.
Results from the SOFAST study were published by Dheeraj Gandhi, MD, et al in the Journal of NeuroInterventional Surgery in June 2024, providing evidence supporting the clinical performance of the SOFIA catheter platform.
Comprehensive Stroke Solution Portfolio
The new SOFIA 88 Catheter seamlessly complements the company's broader stroke solution portfolio, offering a fully integrated approach across aspiration, access, retrieval, and navigation. The comprehensive portfolio includes:
- 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, providing reliable flow arrest with streamlined preparation, optimized compatibility and next-generation balloon technology
- WEDGE Microcatheter, a navigation aid that minimizes ledge effect
- HEADWAY Microcatheters, offering low-profile outer diameter, providing versatility, reliability, and fast access
- TRAXCESS Guidewires, featuring soft-tip design for challenging anatomies
The SOFIA catheter line's clinical foundation is supported by extensive research, including studies published in major journals such as JAMA, The Lancet, and the Journal of NeuroInterventional Surgery, demonstrating efficacy across various stroke intervention approaches and patient populations.
