California-based Radical Catheter Technologies has announced 510(k) clearance from the US Food and Drug Administration (FDA) for its neurovascular catheter, Radical Catheter.
The approval is supported by data presented from a multi-centre analysis at the Society of Neurointerventional Surgery (SNIS) 21st annual meeting in Colorado, US, on 22 July.
The analysis evaluated 85 neuroendovascular procedures including treatments for aneurysms and stroke. Findings determined that the Radical catheter catheterised the target vessel 100% of the time and could reach an intracranial position in all anterior circulation treatment procedures.
Physicians used the Radical catheter for a range of different treatments, including stenting, flow diversion, embolisation, and revascularisation. Of the 85 cases, 72 were trans-arterial and 13 were trans-venous. The Radical catheter is designed to enable access to the blood vessels in the brain for both femoral and radial access.
In addition to approval and new data, the company also announced that it has closed a $20m funding round, led by NeuroTechnology Investors. Radical plans to use the funds to scale up operations and to further advance the platform.
Mount Sinai Health System cardiovascular surgeon Christopher Kellner said: “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.”
An acute ischaemic stroke occurs when a blood vessel in the brain becomes blocked, reducing blood flow and oxygen in the brain tissue. A brain aneurysm is a bulge in a blood vessel in the brain, which can be fatal if it bursts. Catheters remove these blood clots or blockages from the blood vessels, restoring blood flow to the affected area of the brain.
According to a report on GlobalData’s Medical Intelligence Center, the number of neurovascular thrombectomy procedures in the US is forecast to reach 153,691 in 2030.
In a separate development, MIVI Neuroscience announced that it had submitted data to the FDA for clearance of its Q Revascularization System in February 2024, after the company’s EvaQ acute ischaemic stroke study (NCT04437862) met its primary endpoint.
