Third FDA-approved study supports additional potential use of laser ablation technology

Sept. 15, 2016
The FDA has approved an additional Investigational Device Exemption (IDE) to evaluate the NeuroBlate laser ablation system.

The FDA has approved an Investigational Device Exemption (IDE) to evaluate the NeuroBlate laser ablation system from Monteris Medical (Plymouth, MN) in patients newly diagnosed with glioblastoma multiforme (GBM; the most common and deadliest type of primary brain tumor). With this approval, the company will initiate the Feasibility Study on Laser Interstitial Thermal Ablation for the Treatment of Newly Diagnosed GBM (FLAG), an open-label, prospective study that will be conducted in five sites in the United States.

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The system, a type of magnetic resonance imaging (MRI)-guided laser interstitial thermal therapy (LITT), is used by surgeons to destroy and coagulate soft tissue lesions in the brain. The company previously conducted an IDE-approved study to evaluate the system in patients with recurrent GBM, and recently announced an additional IDE approval to evaluate the system in patients with medically refractory epilepsy.

The FLAG study is designed to characterize the safety, feasibility, and effectiveness of the NeuroBlate system in combination with standard of care radiation and chemotherapy in patients with newly diagnosed GBM. The study will enroll participants for whom a complete surgical resection is unsafe because of location, shape, or size of the tumor. Overall survival, progression-free survival, patient quality of life, and healthcare utilization will be assessed during the trial in 30 patients followed for up to 12 months after the procedure and subsequent radiation and chemotherapy. The company expects to initiate the study in the fourth quarter of 2016.

For more information, please visit www.monteris.com.

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