FDA Clears the Toro 88 Superbore Catheter

Toro Neurovascular has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for the Toro 88 Superbore Catheter. The regulatory milestone marks the commercial introduction of the firm’s first proprietary neurovascular access catheter platform.

The Toro 88 Catheter is designed to meet 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 physicians, the platform delivers meaningful procedural value where it matters most: speed, precision, and confidence in complex cases, according to the company.

The Toro 88’s first U.S. clinical use case was successfully performed by Dr. Satoshi Tateshima, professor of Interventional Neuroradiology at UCLA and an internationally recognized expert 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,” Dr. Tateshima said. “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 Neurovascular’s collaboration with Kaneka Corporation, Kaneka Medical America LLC will lead the Toro 88 Catheter’s U.S. launch. By combining Toro’s next-generation catheter engineering with Kaneka’s experienced neurovascular sales organization, established physician relationships, and clinical support infrastructure, the companies are well-positioned to deliver a focused and high-impact market introduction, executives claim.

“We are excited to partner with Toro Neurovascular to bring the Toro 88 to physicians across the United States,” Kaneka Medical America President Ken Toda stated. “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 Neurovascular, the FDA clearance represents the first major regulatory approval for its catheter portfolio and a foundational step in the company’s long-term product strategy.

“This 510(k) clearance is a big step for us,” Toro Neurovascular CEO Hyung Posalit commented. “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 & Kaneka Medical America LLC plan a phased U.S. rollout of the Toro 88 Catheter, with additional product launches and portfolio expansion planned as part of the company’s long-term strategy.

Toro Neurovascular develops high-performance technologies for neurovascular disease treatment. Headquartered in Irvine, Calif., the company combines clinical insight and advanced engineering to enhance patient outcomes worldwide.

Kaneka Corporation is a global healthcare innovation provider, with an expanding neurovascular presence. Through its commitment to scientific advancement and strategic partnerships, Kaneka aims to provide life-saving medical technologies that improve patient care and quality of life.