Radical Catheter Technologies’ 8-F Neurovascular Catheter Gains FDA Clearance

January 15, 2025—Radical Catheter Technologies announced it has received FDA 510(k) clearance for the company’s 8-F Radical neurovascular catheter.

Built on the same platform as Radical’s FDA-cleared 7-F catheter, the new device provides a second size and enlarged inner diameter for expanded therapeutic options, stated the company.

According to the company, the Radical catheter features the company’s next-generation ribbon technology intended for flexibility, stability, and durability. The design also provides mechanical advantages for quicker procedures and lower risks and costs.

Imran Chaudry, MBBS, a neurointerventional radiologist at Prisma Health Systems in Greenville, South Carolina, is an investigator in the clinical evaluation studies of the 7-F catheter and has been using the Radical catheter during the past year, noted the company. Dr. Chaudry commented on the latest FDA clearance in the press release.

“I look forward to using the 8-F catheter where this technology can benefit an even greater number of procedures and patients in my practice,” stated Dr. Chaudry. “Thus far, my experience with the 7 F 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.”

Additionally, Radical Catheter Technologies, which is a NeuroTechnology Investors (NTI) portfolio company, advised it has moved to a state-of-the-art manufacturing facility as part of its commitment to scale operations. The company is enhancing its operations to establish a top-tier manufacturing organization that will support the design of the Radical technology platform and facilitate its commercial growth, advised the press release.