The US Food and Drug Administration (FDA) has granted 510k clearance to ClearMind Biomedical’s new neuroendoscope, the Axonpen System.
The system can illuminate and visualise intracranial tissue and fluids, as well as the controlled tissue and / or fluid aspiration while performing a surgery.
It merges tissue visualisation, suction, and irrigation functions and requires a 6.5mm channel through the skull for insertion into the brain.
Furthermore, the steerable Axonpen can be used with accessory surgical devices.
ClearMind Biomedical noted that the Axonpen System is the first-of-its-kind device to merge all these capabilities into one convenient, minimally invasive operating platform.
The system supports a clinical shift in the minimally invasive removal of unwanted intracranial fluid and tissue, as seen in intracerebral haemorrhage (ICH) and subdural hematomas.
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Using Axonpen, a single surgeon can carry out critical surgeries in one hour even at small-scale regional hospitals.
ClearMind Biomedical CEO Carrey Yang said: “Up until the introduction of the Axonpen System, there has been no other integrated neuroevacuation device on the market for minimally invasive neurosurgery.
“The most critical period in treating ICH is the first 24 hours, underscoring the importance of swift and effective emergency treatment.”
Yang added that apart from the speediness of treatment, the Axonpen’s low rebleeding risk is an equally important advantage.
The first post-market human trial of the device has begun and will have 30 participants.
It will focus on procedural safety, as well as on the creation of a link between the Axonpen use and functional independence measures.
Furthermore, human trials are scheduled to be conducted in the US in the third quarter of this year.