Radical Catheter Technologies Receives FDA 510(k) Clearance for Its Radical Catheter

Radical Catheter Technologies has received FDA 510(k) clearance for its Radical Catheter. The company also presented a multi-center analysis of this technology at Society of NeuroInterventional Surgery 21st annual meeting. In addition, Radical Catheter Technology closed a $20 million financing round led by NeuroTechnology Investors (NTI). Funding will help the company expand the Radical platform.

 

The Radical Catheter features the company’s patented ribbon technology for flexibility, stability, durability, as well as reduced procedural time and associated risks and costs. 

 

The analysis evaluated an array of neurovascular procedures including treatments for aneurysms and strokes. The analysis was performed by 14 operators across six hospitals in four institutions, including the Cleaveland Clinic, Mount Sinai Health System, Prisma Health, and the University at Buffalo. 

 

The Radical Catheter demonstrated catheterization of the target vessel 100% of the time, the ability to reach an intracranial position in all anterior circulation treatment procedures, and no device failures or device-related adverse events. 

 

“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, cerebrovascular neurosurgeon, Mount Sinai Health System. “The operations 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.”

 

The retrospective analysis of neuroendovascular procedures includes 72 trans-arterial and 13 trans-venous cases. 62 procedures were elective and 23 were emergency cases with various treatments. 

 

Radical Catheter Technologies plans to use the $20 million raised funding to expand the company’s platform and leverage strong post-clearance clinical data.