Toro Neurovascular Announces FDA 510(k) Clearance for Toro 88 Superbore Catheter

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First clinical cases successfully completed; U.S. launch to be led by Kaneka’s Neurovascular division IRVINE, Calif., March 11, 2026 (GLOBE NEWSWIRE) -- Toro Neurovascular today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Toro 88 Superbore Catheter, marking a transformative milestone for the company and the commercial introduction of its first proprietary neurovascular access catheter platform. The Toro 88 Catheter was purpose-built for the evolving demands of modern neurointervention. As stroke treatment and complex cerebrovascular procedures increasingly rely on super-bore access to support aspiration-based techniques, physicians require devices that deliver uncompromising support, seamless trackability, and dependable stability in highly tortuous anatomy. Toro 88 was engineered to meet that need – providing super-bore inner diameter capability while maintaining the control, responsiveness, and distal access performance critical in time-sensitive stroke interventions. Developed in close collaboration with leading physicians, the platform reflects Toro’s focus on delivering meaningful procedural value where it matters most: speed, precision, and confidence in complex cases. The first clinical use of Toro 88 in the United States was successfully performed by Dr. Satoshi Tateshima, Professor of Interventional Neuroradiology at UCLA and an internationally recognized leader in neurovascular intervention, who highlighted the catheter’s performance and the significance of its clinical translation. “Large-bore catheters demonstrate clear clinical value. Having been involved in its in-vitro testing and development, I was particularly impressed to see Toro 88 perform in patients exactly as intended – its navigation and trackability matched the design expectations. That level of translation from bench to bedside is highly meaningful,” said Dr. Tateshima. “In my initial case, it delivered the super-bore size and support required without compromising control, which is critical in today’s stroke and complex neurovascular procedures.” Left to right: Hyung Posalit (Toro Neurovascular); Dr. Satoshi Tateshima, Professor of Interventional Neuroradiology at UCLA; Brian Schleiker (Kaneka Neurovascular USA); and Ryan Walker (Toro Neurovascular), following the successful first U.S. clinical use of the Toro 88 Superbore Cathe...

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