Clearmind Biomedical has received US Food and Drug Administration (FDA) 510(k) clearance for its Neuroblade system—a novel neuroendoscopy system that enables minimally invasive procedures with integrated features like visualisation, illumination, irrigation, suction, coagulation, and powered debridement.
The company has also announced the successful completion of the first US surgery using the Neuroblade, performed by Christopher Kellner at Mount Sinai Hospital in New York, USA.
“The Neuroblade system offers a valuable new tool for the surgical management of intracerebral haemorrhage,” Kellner said. “Its minimally invasive design streamlines the operating room setup and integrates essential functions into a single handpiece, potentially improving patient outcomes. The Neuroblade system represents a new class of technology that should simplify neurosurgical procedures and provide patients a chance at more favourable outcomes.”
The Neuroblade system is made up of three components: the Neuroblade, a single-use multifunctional neuroendoscope; the Neuropad, a reusable medical-grade tablet; and Clearpath, a disposable transparent access sheath. This system is designed to improve the efficiency and outcomes of minimally invasive neurosurgical procedures.
In the initial US case, Kellner employed the Neuroblade system during an urgent procedure to evacuate a haemorrhagic stroke. The Clearpath sheath allowed precise access to the target area, while the Neuroblade provided an all-in-one instrument with real-time visualisation and integrated tools for suction, irrigation, powered debridement, and coagulation, according to a Clearmind press release.
“FDA clearance and the first US surgery mark significant milestones for the Neuroblade system, which we believe will revolutionise minimally invasive neurosurgery,” stated J Dustin Duckett, Clearmind’s vice president and general manager for the Americas. “Developed with input from surgeons, Neuroblade’s integrated features aim to enhance surgical efficiency and patient outcomes. We look forward to further developing evidence, driving adoption, and ultimately getting more patients access to desperately needed care.”
