FDA Grants IDE Approval to Monteris Medical’s NeuroBlate Laser System

The FDA has approved an Investigational Device Exemption (IDE) for Monteris Medical’s NeuroBlate System to evaluate in patients newly diagnosed with glioblastoma multiforme (GBM).

The NeuroBlate System is a type of MRI-guided laser interstitial thermal therapy (LITT) that is used by surgeons to destroy and coagulate soft tissue lesions in the brain.

GBM is the most common and deadliest type of primary brain tumor. It occurs most commonly in adults between the ages of 45 and 70 years and it accounts for 52 percent of primary brain tumors, and about 17 percent of all brain tumors. The five-year relative survival rate for GBM ranges from 4 to 17 percent and decreases with age. — Cynthia Jessup