Radical Catheter Technologies has announced 510(k) clearance by the US Food and Drug Administration (FDA) for its Radical catheter—which, the company claims in a recent press release, is “the first significant advance in catheter technology in more than three decades”. This new catheter—the first product commercialised from Radical’s novel technology platform—is designed to enable access to blood vessels in the brain for both femoral and radial access.
A multicentre analysis representing initial post-market clinical experiences with the Radical catheter was presented earlier this week at the Society of NeuroInterventional Surgery (SNIS) annual meeting (22–26 July, Colorado Springs, USA).
In addition to this, Radical has confirmed the closing of a US$20 million financing round led by NeuroTechnology Investors (NTI), which will be used to scale the company and expand the Radical platform.
“While catheters are the foundation of every neurovascular procedure I perform, current gaps in catheter technology fundamentally limit complex life-saving procedures,” said Christopher Kellner (Mount Sinai Health System, New York, USA), who presented the aforementioned initial clinical analysis at SNIS 2024. “The operators in this pilot experience consistently commented on a number of advantages to the Radical catheter, including greater flexibility to access targeted areas, more stability and increased durability. In our initial case series, the Radical catheter consistently reached further territories of the brain than we are accustomed to with conventional catheters. With this dramatically better performance, I expect to be able to more easily address complex procedures.”
The analysis evaluated a wide array of neuroendovascular procedures—including treatments for aneurysms and stroke—that were performed by 14 operators across six hospitals in four institutions, consisting of the Mount Sinai Health System, Cleveland Clinic (Cleveland, USA), Prisma Health (Greenville, USA) and University at Buffalo (Buffalo, USA).
Radical claims in a press release that the analysis’ findings indicate that its catheter demonstrated “best-in-class performance”, including:
- Catheterisation of the target vessel 100% of the time
- Ability to reach an intracranial position in all anterior circulation treatment procedures
- No device failures or device-related adverse events
- Elimination of the need for and use of intermediate catheters in the majority of procedures in which one would have typically been used, due to ease of distal access with the Radical catheter
In total, this retrospective analysis of 85 neuroendovascular procedures included 72 transarterial and 13 transvenous cases. Of these procedures, 62 were elective and 23 emergency cases, consisting of various treatments, including stenting, flow diversion, embolisation and revascularisation. This initial experience represents the full range of complex neurovascular cases, including several procedures where other catheters first failed to reach the targeted vessel, Radical also notes.
The design features of the Radical catheter’s patented ribbon technology aim to deliver best-in-class flexibility, stability and durability—and also have the additional benefits of reducing procedural time, and associated risks and costs, the company claims.
Radical plans to use the US$20 million raised through NTI and other investors who have backed the core group over many ventures to expand its platform and leverage these strong post-clearance clinical data. In parallel, the company is scaling operations to build a world-class manufacturing organisation to support the advanced design of its Radical technology platform and commercial expansion.
Radical is exhibiting its new technology at the ongoing SNIS meeting—together with other innovative NTI portfolio companies, including Synchron, Serenity Medical and Borvo Medical.
