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