The FDA has approved Monteris Medical (Plymouth, MN)'s Investigational Device Exemption (IDE) to evaluate the company's NeuroBlate laser ablation system in medically refractory epilepsy. With this approval, the company will initiate the Feasibility Study on Laser Interstitial Thermal Ablation for the Treatment of Medically Refractory Epilepsy (FLARE). This multicenter, open-label prospective study is expected to enroll up to 45 subjects at as many as eight clinical sites in the U.S., with the goal of evaluating approximately 30 patients using laser interstitial thermal therapy (LITT) for neurosurgical applications.
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Since obtaining initial FDA clearance in 2013, the NeuroBlate system has been used by surgeons to destroy and coagulate neurosurgical soft tissue lesions.
The FLARE study will help to determine whether patients may benefit from a minimally invasive procedure such as LITT, explains Dennis Spencer, MD, chair of the Department of Neurosurgery at the Yale University School of Medicine (New Haven, CT) and principal investigator of the study. The FLARE study aims provide important insight into the safety and efficacy of the approach and its potential impact on neurocognition and seizures, he adds.
FLARE is designed to evaluate the performance of LITT using the NeuroBlate system for the treatment of drug-refractory medial temporal lobe epilepsy in appropriate candidates. The primary endpoint of the study is to characterize 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. The company expects to initiate FLARE in the second half of 2016 and estimates that it will take approximately 3.5 years to complete the study.
For more information, please visit www.monteris.com.
