Monteris Medical has announced that the US Food and Drug Administration (FDA) has approved the Investigational Device Exemption (IDE) to evaluate the NeuroBlate System in medically refractory epilepsy. With this approval, Monteris will initiate the Feasibility study on laser interstitial thermal ablation for the treatment of medically refractory epilepsy (FLARE). This multicentre, open-label prospective study is expected to enrol up to 45 patients at as many as eight clinical sites in the USA, with the goal of evaluating approximately 30 patients using laser interstitial thermal therapy (LITT) for neurosurgical applications.
Since obtaining initial FDA clearance in 2013, the NeuroBlate System has been used by surgeons to destroy and coagulate neurosurgical soft tissue lesions.
The Centers for Disease Control and Prevention estimate that there are about 2.9 million people in the USA with active epilepsy and that about one third of these patients continue to experience seizures despite treatment with one or more anti-epileptic drugs.
“Many refractory epilepsy patients in the USA are eligible for resection surgery treatment, but the vast majority of patients and their doctors choose not to undertake such an invasive procedure due to the underlying risks associated with traditional open brain surgery,” says Dennis Spencer, chair of the Department of Neurosurgery at Yale University School of Medicine and principal investigator of the study. “The FLARE study will help to determine whether patients may benefit from a minimally invasive procedure, such as LITT. FLARE is designed to provide important insight into the safety and efficacy of this approach and its potential impact on neurocognition and seizures. This study is an important step forward in evaluating a new modality designed for medically refractory epilepsy.”
FLARE is designed to evaluate the performance of LITT using the Monteris NeuroBlate System for the treatment of drug-refractory medial temporal lobe epilepsy in appropriate candidates. The primary endpoint of the study is to characterise the safety of laser ablation surgery with the NeuroBlate System in this patient population, including evaluation of adverse events and neuropsychological changes. Seizure outcome and quality of life will be evaluated as secondary endpoints. Patients enrolled in the study will undergo laser ablation surgery and will then be followed for 24 months. Monteris Medical expects to initiate FLARE in the second half of 2016 and estimates that it will take approximately 3.5 years to complete the study.
“Refractory epilepsy represents a significant unmet medical need. The FLARE study will help increase our understanding of the potential benefit the NeuroBlate System may have on the quality of life of patients living with this serious and debilitating disease,” says Daryle Petersen, vice president, Clinical Affairs at Monteris Medical.