Radical Catheter Tech Wins FDA Nod for 6F Neurovascular Access Catheter

Radical Catheter Technologies (RCT), a NeuroTechnology Investors (NTI) portfolio company, was granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its 6F neurovascular access catheter.

The 6F sized catheter joins the company’s first two FDA-cleared catheters. RCT said the FDA nod broadens therapeutic options, particularly for middle-meningeal artery (MMA) embolization. It also expands availability in radial access procedures.

“The 6F’s lower profile delivers best-in-class performance across both radial and femoral access,” said Johanna Fifi, MD, neurovascular surgeon and Professor of Neurosurgery, Neurology, and Radiology at The Mount Sinai Hospital. “Built on the foundation Radical Catheter Technologies has already established, the 6F becomes an immediate top choice, particularly in challenging cases.”

The Radical catheter was built on a patented ribbon technology that’s designed for simultaneous flexibility, push, and stability, in addition to the durability needed when navigating complex anatomy. A thinner wall construction offers a greater inner diameter relative to outer diameter and a smooth, continuous liner enables delivery of other therapeutic devices.

“We have spent years developing a truly innovative, best-in-class catheter platform that directly addresses performance gaps physicians have long identified,” commented Radical Catheter Technologies CEO Brian Martin. “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,”

The company said it’s also bolstering its sales model by integrated neurovascular access and delivery capabilities with synergistic tech in the NTI portfolio. One example is Serenity Medical’s River stent, which was recently awarded FDA Humanitarian Device Exemption (HDE) approval for adults with severe, refractory idiopathic intracranial hypertension (IIH).

“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, VP of commercial at Radical Catheter Technologies. “This commercialization 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.”