FDA clears new large-bore catheter for challenging stroke cases
Toro Neurovascular, a California-based medtech company focused on developing new treatments for stroke and other neurovascular conditions, has secured U.S. Food and Drug Administration (FDA) clearance for its new Toro 88 Superbore Catheter.
The large-bore device was built to provide support, trackability and stability during the treatment of time-sensitive stroke patients. According to Toro Neurovascular, the company worked closely with physicians to ensure it can deliver value to care teams treating even the most challenging cases.
Satoshi Tateshima, MD, PhD, a professor of interventional neuroradiology at UCLA, performed the first clinical use case with the Toro 88 device in the United States.
“Large-bore catheters demonstrate clear clinical value,” he said in a statement. “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.”
Kaneka Medical America, a U.S. subsidiary of Kaneka Corporation, will be leading the U.S. launch of this device. Toro Neurovascular and Kaneka Corporation have an ongoing collaboration focused on matching the clinical expertise of the former with the sales experience of the latter.
“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,” Hyung Posalit, CEO of Toro Neurovascular, said in the same statement. “We are thrilled to see our innovation move from concept to clinical reality and excited about the impact it will have in stroke care.”
“We are excited to partner with Toro Neurovascular to bring the Toro 88 to physicians across the United States,” added Ken Toda, president of Kaneka Medical America. “This is a truly differentiated super-bore catheter that aligns perfectly with where neurointervention is heading.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.