Monteris Medical’s NeuroBlate System receives 510(K) clearance


Monteris Medical announced that the US Food and Drug Administration (FDA) have issued a second 510(k) clearance for their magnetic resonance imaging (MRI)-guided ablation device for brain tumours and other lesions. The NeuroBlate System is a second generation device employing a surgical laser to ablate diseased brain tissue with updated visualisation provided by active MRI, according to the company. A first generation system has been available in US hospitals since 2010.

Gene Barnett, Burkhardt chair in Neurosurgical Oncology, Cleveland Clinic Neurological and Cancer Institutes, Cleveland, USA said: “The NeuroBlate System will make laser ablation of brain lesions accessible to more neurosurgeons by virtue of its intuitive user interface and time-saving enhancements. Cleveland Clinic will soon be employing this tool to treat brain tumour patients who are seeking a minimally invasive option or are not candidates for traditional surgery.”

“Monteris invested significant resources to develop a laser ablation system that is faster and adapts to contemporary clinical workflow,” said John Schellhorn, president and CEO. “The NeuroBlate System provides neurosurgeons controlled, three-dimensional ablation via a powerful software platform. It supports surgical decision making during brain operations as well as providing post-procedure confirmation of the effects of the thermal therapy. We believe the NeuroBlate System will offer a new option for surgeons managing patients with brain tumors and other neurologic lesions.”