ClearMind Biomedical has announced 510(K) US Food and Drug Administration (FDA) clearance for its Axonpen System, which is used for the illumination and visualisation of intracranial tissue and fluids, and the controlled aspiration of tissue and/or fluid during surgery.
According to ClearMind, the Axonpen System supports a clinical shift in the minimally invasive removal of unwanted intracranial fluid and tissue, as commonly manifested in cases of intracerebral haemorrhage (ICH) and subdural haematomas.
ClearMind states that the objective driving its founders when creating the Axonpen System was “One Doctor, One Hour”, and that meeting this objective allows a single surgeon to complete some critical surgeries in one hour, even at small-scale regional hospitals. Additionally, access to faster neurosurgical interventions after suffering a haemorrhagic stroke or other fluid producing injury has the potential to improve patient outcomes, including survival.
“Up until the introduction of the Axonpen System, there has been no other integrated neuro-evacuation device on the market for minimally invasive neurosurgery,” explained Carrey Yang, ClearMind’s CEO (Taipei City, Taiwan). “Often, expensive and complex equipment is necessary to perform the surgery, requiring that patients be transferred to a large medical center, delaying the moment surgery can begin,” he added.
Yang also pointed out examples where the Axonpen may provide benefit: “The most critical period in treating ICH is the first 24 hours, underscoring the importance of swift and effective emergency treatment.” He went on to comment that apart from the speediness of treatment, the Axonpen’s low rebleeding risk is an equally important advantage.
According to a press release from the company, the first post-market human trial of the Axonpen has commenced. The trial, which will consist of 30 subjects, is focused on procedural safety and generating the correlation between the use of the Axonpen System and functional independence measures. US human trials are planned for the third quarter of 2021.