Monteris is sponsoring this multicenter, open-label, prospective feasibility study to characterize the performance of laser interstitial thermal therapy (LITT) using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.~The NeuroBlate System uses precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to healthy tissue. Unlike traditional brain surgery, LITT does not require a large opening in the skull.~Subjects who meet the study eligibility criteria and sign the informed consent form will undergo the LITT procedure. Subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. The study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health.~Subjects treated with NeuroBlate will have 2 years of follow-up. Throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.
Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for LITT surgery.