Radical Catheter Technologies, a NeuroTechnology Investors (NTI) portfolio company, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its 6F neurovascular access catheter. This latest milestone marks another important step as Radical Catheter Technologies accelerates the evolution of its catheter platform. The 6F joins the company’s first two FDA-cleared catheters and broadens therapeutic options, particularly for middle-meningeal artery (MMA) embolisation, and further expands availability in radial access procedures.
“The FDA clearance of the 6F Radical catheter is a meaningful advancement for our patients,” said Johanna Fifi, MD, neurovascular surgeon and Professor of Neurosurgery, Neurology, and Radiology at The Mount Sinai Hospital, New York, NY. “The 6F’s lower profile delivers best-in-class performance across both radial and femoral access. Built on the foundation Radical Catheter Technologies has already established, the 6F becomes an immediate top choice, particularly in challenging cases.”
“We have spent years developing a truly innovative, best-in-class catheter platform that directly addresses performance gaps physicians have long identified. With our novel technology, we are exceeding these expectations and positioning the Radical platform to serve as the foundation for continued innovation in neuroendovascular procedures,” said Brian Martin, CEO and co-founder of Radical Catheter Technologies.
The Radical catheter is built on patented ribbon technology designed to deliver simultaneous flexibility, push, and stability, along with the durability physicians need when navigating complex anatomy. With a thinner wall construction that provides a greater inner diameter relative to outer diameter and a smooth, continuous liner to enable the delivery of other therapeutic devices, the Radical platform provides significant mechanical advantages to support procedural efficiency and performance.
Beyond catheters, Radical Catheter Technologies is actively broadening its commercialisation model by integrating its neurovascular access and delivery capabilities with synergistic technologies across the NTI portfolio. A prime example is Serenity Medical's River stent, recently granted FDA Humanitarian Device Exemption (HDE) approval for adult patients with severe, refractory idiopathic intracranial hypertension (IIH) — which exemplifies the calibre of innovation Radical Catheter Technologies is positioned to bring to market.
“The FDA 510(k) clearance of our latest 6F access catheter further validates the breadth of our platform across a wide range of neurovascular applications,” said Alex Thomson, Vice President of Commercial at Radical Catheter Technologies. “This commercialisation model unites some of the most compelling technologies in the neurovascular space, while providing the infrastructure to advance and support the best-in-class solutions we represent.”
