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 Catheter.
As part of Toro Neurovascular’s collaboration with Kaneka Corporation, Kaneka Medical America LLC will lead the U.S. launch of the Toro 88 Catheter. By combining Toro’s next-generation catheter engineering with Kaneka’s experienced neurovascular sales organization, established physician relationships, and robust clinical support infrastructure, the companies are well positioned to deliver a focused and high-impact market introduction.
“We are excited to partner with Toro Neurovascular to bring the Toro 88 to physicians across the United States,” said Ken Toda, President of Kaneka Medical America LLC. “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,” said Hyung Posalit, Chief Executive Officer of Toro Neurovascular. “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.
About Toro Neurovascular
Toro Neurovascular develops high-performance technologies for the treatment of neurovascular disease. Headquartered in Irvine, California, the company combines clinical insight and advanced engineering to enhance patient outcomes worldwide.
Learn more: www.toroneuro.com
About Kaneka
Kaneka Corporation is a global leader in healthcare innovation, 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.
Media Contact:
info@toroneuro.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e5fe21d9-9a56-4629-8c3d-e01a7e9c0169
