ClearMind Biomedical announced today that it received FDA clearance for its Axonpen novel neuroendoscope system.
Los Angeles-based ClearMind Biomedical’s Axonpen system is designed for the illumination and visualization of intracranial tissue and fluids, as well as the controlled aspiration of tissue and/or fluid during surgery, according to a news release.
The system requires a 6.5 mm channel through the skull for insertion into the brain before combining tissue visualization, suction and irrigation functions. Its working channel allows use with accessory surgical devices while the company touts it as the first neuroendoscope to integrate all of these capabilities into one.
ClearMind has commenced the first post-market human trial of the Axonpen system, with 30 subjects and a focus on procedural safety and generating the correlation between the use of the Axonpen system and functional independence measures. The company is planning for U.S. human trials in the third quarter of 2021.
“Up until the introduction of the Axonpen system, there has been no other integrated neuroevacuation device on the market for minimally invasive neurosurgery,” ClearMind CEO Carrey Yang said in the release. “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.”