Radical Catheter Technologies—a NeuroTechnology Investors (NTI) portfolio company—announced today that the US Food and Drug Administration (FDA) has granted 510(k) clearance to its 6F neurovascular access catheter.
The company states in a press release that this latest milestone marks another important step as it accelerates the evolution of its catheter platform, with the 6F joining Radical’s first two US FDA-cleared catheters, and broadening therapeutic options—particularly for middle meningeal artery (MMA) embolisation—and further expanding availability in radial access procedures.
“The FDA clearance of the 6F Radical catheter is a meaningful advancement for our patients,” commented Johanna Fifi (Mount Sinai Hospital, New York, USA). “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.”
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, as per the company’s recent release. With a thinner wall construction that provides a greater inner diameter relative to outer diameter—and a smooth, continuous liner enabling the delivery of other therapeutic devices—the Radical platform is intended to offer “significant mechanical advantages” to support procedural efficiency and performance.
“We have spent years developing a truly innovative, best-in-class catheter platform that directly addresses performance gaps physicians have long identified,” said Brian Martin, chief executive officer (CEO) and co-founder of Radical. “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 FDA 510(k) clearance of our latest 6F access catheter further validates the breadth of our platform across a wide range of neurovascular applications,” added Alex Thomson, the company’s vice president of commercial. “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.”
Radical says it is planning to exhibit its patented technology platform at this year’s Society of NeuroInterventional Surgery (SNIS) annual meeting (20–24 July, Seattle, USA), together with fellow innovative NTI portfolio companies including Synchron, Serenity Medical and Borvo Medical.
