NeuroBlate System Receives 510(k) Clearance

Monteris Medical officials announce that the U.S. FDA has issued a second 510(k) clearance for their MRI-guided ablation device for brain tumors and other lesions. The NeuroBlate System is a second generation medical device employing a surgical laser to ablate (lethally heat) diseased brain tissue with updated visualization provided by active MRI. A first generation system has been available in US hospitals since 2010.

Dr. Gene Barnett, MD, MBA, Burkhardt Chair in Neurosurgical Oncology, Cleveland Clinic Neurological and Cancer Institutes offers, “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 tumor 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,” states 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.”