Monteris Medical said today it won FDA investigational device exemption clearance for a trial of its NeuroBlate system for treating medically refractory epilepsy.
The NeuroBlate system is designed to ablate, necrotize or coagulate soft tissue during neurosurgery procedures through laser thermotherapy, and is not intended for any specific disease or lesion type, the company said.
The Plymouth, Minn.-based company said with the clearance it will initiate the multicenter, open-label Flare study, looking to enroll 45 patients at up to 8 clinical sites in the U.S. The trial aims to evaluate 30 patients using laser interstitial thermal therapy for treating drug-refractory medial temporal lobe epilepsy.
“Many refractory epilepsy patients in the U.S. 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. 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,” principal investigator Dr. Dennis Spencer of the Yale University School of Medicine said in prepared remarks.
The primary endpoint for the study is to characterize the safety of laser ablation surgery with the system as well as the evaluation of adverse events and neuropsychological changes. Seizure outcome and quality of life will serve as secondary endpoints, the company said.
Patients in the trial will undergo laser ablation surgery and be followed for 24 months. Monteris Medical said it expects to iniate the Flare study in the 2nd half of 2016, and will take approximately 3.5 years to complete.
“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,” Monteris Medicals veep of clinical affairs Daryle Petersen said in a press release.
Last November, Monteris Medical said a pair of new backers joined a $30 million Series B round it plans to use to expand the commercial footprint of its NeuroBlate robotic brain tumor laser.
Monteris in April 2013 won 510(k) clearance from the FDA and a nod from Health Canada for the minimally invasive NeuroBlate device, which allows physicians to use an MRI-guided laser system to heat and kill brain tumors.