Toro Neurovascular’s Toro 88 Superbore Catheter Cleared by FDA 

March 11, 2026—Toro Neurovascular announced FDA 510(k) clearance and commercial introduction of the Toro 88 superbore catheter, a neurovascular access catheter platform.

As part of Toro Neurovascular’s collaboration with Kaneka Corporation, Kaneka Medical America LLC will lead the United States launch of the Toro 88 catheter. The companies are planning a phased rollout of the Toro 88 catheter in the United States. Additional product launches and portfolio expansion are also planned as part of the company’s long-term strategy.

According to the company, Toro 88 provides superbore inner-diameter capability while maintaining control, responsiveness, and distal access performance for stroke interventions.

The company stated that the first clinical use of Toro 88 in the United States was performed by Satoshi Tateshima, MD, Professor of Interventional Neuroradiology at UCLA in Los Angeles, California.

“Large-bore catheters demonstrate clear clinical value,” commented Dr. Tateshima in the company’s press release. “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 added, “In my initial case, it delivered the superbore size and support required without compromising control, which is critical in today’s stroke and complex neurovascular procedures.”