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Monteris Medical wins FDA IDE approval to assess NeuroBlate system in GBM patients

Monteris Medical has secured an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to conduct the study for evaluating the NeuroBlate system in patients diagnosed with glioblastoma multiforme (GBM).

NeuroBlate system is a type of MRI-guided laser interstitial thermal therapy (LITT) that will enable surgeons to destruct and coagulate soft tissue lesions in the brain.

The company will carry out an open label feasibility study on laser interstitial thermal ablation for the treatment of newly diagnosed GBM (FLAG) at five sites in the US.

FLAG study will 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 company plans to start the study in the fourth quarter of this year.

Earlier, the firm carried out an IDE approved trial to assess the NeuroBlate system in patients with recurrent GBM.

Recently, an additional IDE approval has been granted to evaluate the system in patients with medically refractory epilepsy.

Monteris Medical clinical affairs vice president Daryle Petersen said: "Monteris Medical is committed to addressing unmet medical needs by evaluating new options for patients with severe neurological disorders, and the IDE process enables us to do so in a carefully regulated, clinically rigorous environment.

"We are optimistic that results from the FLAG study will expand our knowledge of LITT in this patient population."

Monteris also produces Mini-Bolt cranial bolt system that allows a robotic interface for protected and precise therapy deliver, as well as AtamA stabilization system for MRI-guided neurosurgical procedures requiring head fixation.