FDA-Cleared Endovascular Technology Unveiled at SNIS 21st Annual Meeting

At the Society of NeuroInterventional Surgery (SNIS) 21st Annual Meeting, Radical Catheter Technologies, presented their innovative Neurovascular Radical Catheter. The company obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its novel endovascular technology, marking a pivotal advancement as the first significant innovation in catheter technology in more than 3 decades.

The Radical Catheter, developed to facilitate access to the brain's blood vessels through femoral and radial access, was the focus of a multi-center analysis presented at the SNIS annual meeting.

While presenting the initial clinical analysis, Christopher Kellner, MD, a cerebrovascular neurosurgeon at Mount Sinai Health System, emphasized the impressive performance advantages observed during the initial post-market clinical experience. 

“While catheters are the foundation of every neurovascular procedure I perform, current gaps in catheter technology fundamentally limit complex life-saving procedures. 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,” said Dr Kellner. “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, which included a diverse range of neuroendovascular procedures performed by 14 operators across 6 hospitals in 4 institutions, revealed the following key findings:

• The catheter successfully reached target vessels 100% of the time;
• The device reached intracranial positions in all anterior circulation treatment procedures;
• No device failures or adverse events were reported; and
• The use of intermediate catheters was eliminated in the majority of procedures due to the Radical Catheter's ease of distal access.

The patented ribbon technology incorporated into the design of the Radical Catheter “aim[s] to deliver best-in-class flexibility, stability, and durability,” while also minimizing procedural time and associated risks and costs, the manufacturer said in a news release.

At the SIRS meeting, the company also confirmed the closing of a $20 million financing round. “The company plans to use the $20 million raised through NeuroTechnology Investors and other investors who have backed the core group over many ventures to expand the Company's platform and leverage the strong post-clearance clinical data,” they said.

Reference

Radical Catheter Technologies presents analysis of disruptive, recently FDA-cleared endovascular technology at the Society of NeuroInterventional Surgery (SNIS) 21st Annual Meeting. News Release. Radical Catheter Technologies; July 22, 2024. Accessed August 9, 2024.