MRI-guided laser ablation technology developer Monteris Medical said the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption application for a study of the firm's NeuroBlate technology in a potential new indication.
The prospective study will evaluate the use of NeuroBlate in patients newly diagnosed with glioblastoma multiforme (GBM). Called the Feasibility Study on Laser Interstitial Thermal Ablation for the Treatment of Newly Diagnosed GBM (FLAG), the research will be conducted in five U.S. states, and will characterize the safety, feasibility, and effectiveness of NeuroBlate in combination with radiation and chemotherapy, Monteris said. The study is expected to begin in the fourth quarter.
