Radical Catheter Technologies, a NeuroTechnology Investors (NTI) portfolio company, has announced the Food and Drug Administration (FDA) clearance of its 8Fr neurovascular catheter, marking the company’s second 510(k) clearance from the US regulator. A press release labels this as another milestone achievement for Radical, adding that it highlights the “unprecedented potential” of its catheter technology.
“I look forward to using the 8Fr catheter where this technology can benefit an even greater number of procedures and patients in my practice,” said Imran Chaudry (Prisma Health Systems, Greenville, USA), an investigator in the clinical evaluation studies of the 7Fr who has been using the Radical catheter over the past year. “Thus far, my experience with the 7Fr has been stellar, and it has become a mainstay catheter for daily use. It delivers first-in-class performance, exceeding expectations and making complex cases much easier—particularly where other catheters would face challenges.”
Built upon the same patented platform as Radical’s 7Fr catheter—the first US FDA-cleared product from the company—the 8Fr catheter is said to provide a second size and enlarged inner diameter to “greatly expand” therapeutic options.
The release goes on to detail that the recent announcement of the company’s move to a state-of-the-art manufacturing facility underscores Radical’s commitment to scaling operations and creating a world-class manufacturing entity that supports the continued advanced design of its platform, and facilitates the process of commercial expansion.
“I am pleased with the growth and accomplishments related to the company’s key strategic objectives to set a new standard in neurovascular access and delivery,” said Brian Martin, co-founder and chief executive officer (CEO) of Radical. “First, the rapid clearance of the 8Fr Radical catheter, following the clinical success of the 7Fr, marks a critical milestone toward offering a comprehensive range of sizes and indications for neurovascular procedures. Second, the construction of our world-class manufacturing facility, completed last month [December 2024], supports the company’s highly anticipated growth. This state-of-the-art facility ensures we can accommodate large-volume orders for the full platform of catheters.”
Martin Dieck, Radical’s chairman and co-founder, added: “Our clinical experience has been remarkable, consistently demonstrating the best-in-class performance of our FDA-cleared catheters at initial commercial sites. The Radical catheter has firmly established itself as a workhorse, capable of navigating everything from routine procedures to the most complex and challenging cases. We are encouraged by the field performance to date, as highlighted by direct physician feedback and reinforced by robust replenishment orders from our initial clinical sites. In the coming months, we plan to achieve additional milestones that will expand our platform further and propel us into a full commercial launch.”
The Radical catheter features patented, next-generation ribbon technology that delivers “exceptional” flexibility, stability, and durability, the company claims, also stating that this design provides “unmatched” mechanical advantages, leading to quicker procedures as well as lower risks and costs. Guided by NTI, Radical says it is enhancing its operations to establish a top-tier manufacturing organisation that will support the innovative design of its technology platform and facilitate its commercial growth.
