FDA gives go-ahead to use of Medtronic device in epilepsy trial

The FDA has approved the testing of Medtronic’s Visualase laser ablation system in an epilepsy clinical trial.

According to Epilepsy Research UK, the device will be used in a trial of people with drug-resistant mesial temporal lobe epilepsy (MTLE).

Dr Robert Gross, professor of neurosurgery at Emory University, in Atlanta, said: “This is a significant step in collecting evidence regarding laser ablation as a treatment option for MTLE. We are eager to begin enrolling patients.”

Visualase is an MRI-guided laser ablation system. It works by delivering laser (or light) energy to the desired area of the brain via a laser applicator, with the assistance of real-time MRI imaging. This makes the temperature in that area rise and coagulate the unwanted soft tissue. The laser applicator is just 1.65 mm in diameter and therefore a minimal suture is required following the operation.

The device has already been cleared by the FDA to coagulate or necrotise soft tissue in brain or other specialised surgeries. However this is the first time that it will be trialled in people with epilepsy.

Disclaimer: Epilepsy Research UK is completely neutral and is not affiliated with any commercial company, or any particular device/product.