Toro Neurovascular has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Toro 88 super-bore catheter, marking the commercial introduction of the company’s first proprietary neurovascular access catheter platform.
Additionally, the first clinical use of Toro 88 in the USA was recently successfully performed by Satoshi Tateshima (University of California Los Angeles [UCLA], Los Angeles, USA), who highlighted the catheter’s performance and the significance of its translation into clinical practice.
“Large-bore catheters demonstrate clear clinical value,” Tateshima said. “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. 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.”
As part of Toro’s collaboration with Kaneka Corporation, Kaneka Medical America is set to lead the US launch of the Toro 88 catheter. As noted in a press release, this alliance will combine Toro’s next-generation catheter engineering with Kaneka’s experienced neurovascular sales organisation, established physician relationships, and robust clinical support infrastructure.
“We are excited to partner with Toro Neurovascular to bring the Toro 88 to physicians across the USA,” said Kaneka Medical America president Ken Toda. “This is a truly differentiated super-bore catheter that aligns perfectly with where neurointervention is heading. It brings meaningful innovation to physicians who are looking for both performance and reliability in demanding cases.”
For Toro, this US FDA clearance represents the first major regulatory approval for its catheter portfolio and a “foundational step” in the company’s long-term product strategy, the release adds.
“This 510(k) clearance is a big step for us,” commented Toro chief executive officer (CEO) Hyung Posalit. “The Toro 88 represents the beginning of a new generation of neurovascular devices grounded in purposeful engineering and physician partnerships, designed to set a new standard for high-performance catheters in this field. We are thrilled to see our innovation move from concept to clinical reality, and excited about the impact it will have in stroke care.”
Toro and Kaneka are planning a phased US rollout of the Toro 88 catheter, with additional product launches and portfolio expansions also in the works.
