Monteris Medical Wins FDA Clearance For Epilepsy Study
Monteris Medical recently received FDA clearance to perform a comprehensive study known as an investigational device exemption. The Plymouth-based company hopes the clinical trials performed will prove its NeuroBlate system is effective in surgical treatments of epilepsy.
The Centers for Disease Control and Prevention estimates that roughly 1 million epileptic Americans still experience seizures despite taking one or more anti-epileptic drugs, a condition known as medically refractory epilepsy. Monteris aims to treat this population through conclusions made during its FLARE study—more broadly referred to as the Feasibility Study on Laser Interstitial Thermal Ablation for the Treatment of Medically Refractory 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,” said Dennis Spencer, chair of Yale University’s medicine school and principal investigator of the FLARE study.
Spencer called the FLARE study “an important step forward” in understanding how epilepsy can be treated through minimally invasive procedures.
Monteris expects to enroll 45 subjects for its study with the goal of evaluating 30 patients. The primary endpoint of the study is to characterize how safe laser ablation surgery is using Monteris’ NeuroBlate system, and secondly how the patient’s seizure outcome and quality of life changed in the following 24 months after the surgery. Monteris plans to launch its FLARE study in the second half of 2016 and estimates it will take three-and-a-half years to complete.
In 2013, the FDA cleared Monteris’ NeuroBlate system, which combines the use of catheters, lasers and MRI machines to assist neurosurgeons in treating brain tumors. The neurosurgical tool is now installed in 35 medical institutions in the U.S. and Canada and has been used in more than 800 patient procedures.
Last month, Monteris announced expansion plans from its previous Plymouth headquarters to a larger, 16,000-square-foot space two miles away. Company officials said the move was done in part to house its burgeoning staff of 60 workers—expected to be 78 by the end of 2016—and nearly double what it was two years ago.