FDA 510(k) Clearance Granted to Neurovascular Access Catheter

The Food and Drug Administration (FDA) has granted 510(k) clearance to the Toro 88 Superbore Catheter (Toro Neurovascular, Irvine, CA), a large-bore neurovascular access catheter designed for use in stroke treatment and complex cerebrovascular procedures. The clearance marks the first commercial neurovascular catheter platform for the company.

According to a statement released from Toro Neurovascular, the Toro 88 Superbore Catheter was developed in collaboration with interventional neuroradiologists and evaluated via in-vitro bench testing prior to its first clinical use. The company states that the catheter was designed to navigate highly tortuous intracranial anatomy, and its initial US clinical use was performed by Satoshi Tateshima, MD, Professor of Interventional Neuroradiology at UCLA. The US commercial launch of the Toro 88 Superbore Catheter will be led by Kaneka Medical America (New York, NY), leveraging its existing physician relationships and clinical support infrastructure.

Toro Neurovascular announced the following features of the cleared device:

• Super-bore inner diameter to support large-bore access and aspiration-based techniques in acute stroke intervention.
• Trackability and navigability through tortuous anatomy without sacrificing distal access or operator control.
• Bench-to-bedside translation, with in-vitro performance consistent with initial clinical case outcomes.

“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.”

Source: Toro Neurovascular. Toro Neurovascular announces FDA 501(k) clearance for Toro 88 Superbore Catheter. Press release. Published March 11, 2026. Accessed March 25, 2026. https://www.globenewswire.com/news-release/2026/03/11/3253906/0/en/Toro-Neurovascular-Announces-FDA-510-k-Clearance-for-Toro-88-Superbore-Catheter.html