Radical Catheter Technologies 7-F Radical Neurovascular Catheter Receives FDA Clearance

July 22, 2024—Radical Catheter Technologies, a medical device company developing endovascular access and delivery products, announced FDA 510(k) clearance for the Radical catheter. The new 7F Radical catheter has neurovascular clearance for both femoral and radial access.

Additionally, the company confirmed the closing of a $20 million financing round that will be used to expand the company’s platform and leverage the post-clearance clinical data. The company is building a manufacturing organization to support the design of the Radical technology platform and its commercial expansion. The financing was led by NeuroTechnology Investors.

The company also announced the presentation of a multicenter analysis of the technology by Christopher Kellner, MD, at the Society of NeuroInterventional Surgery’s 21st annual meeting held July 22-26 in in Colorado Springs, Colorado. Dr. Kellner is a cerebrovascular neurosurgeon at Mount Sinai Health System in New York, New York.

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, including the Cleveland Clinic in Cleveland, Ohio; Mount Sinai Health System; Prisma Health in South Carolina; and the University at Buffalo in Buffalo, New York.

As summarized in the press release, this retrospective analysis included 85 neuroendovascular procedures (72 transarterial; 13 transvenous). Of these procedures, 62 were elective and 23 were emergency cases, with various treatments—including stenting, flow diversion, embolization, and revascularization.

This initial experience represents the full range of complex neurovascular cases, including several procedures in which other catheters first failed to reach the targeted vessel, noted the company.

The findings were outlined in the press release as follows:

• Catheterization of the target vessel in 100% of procedures
• 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, because of its ease of distal access with the Radical catheter

As noted in the company’s press release, Dr. Kellner commented in his presentation, “While catheters are the foundation of every neurovascular procedure I perform, current gaps in catheter technology fundamentally limit complex life-saving procedures.”

Dr. Kellner continued, “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.”