20-06-2016 | FDA approves testing of new surgical device in epilepsy trial

Medtronic plc, a medical device company based in Dublin, announced on Friday that the US Food and Drug Administration (FDA) has approved the testing of its Visualase(TM) laser ablation system in a clinical trial.

The device will now 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."

About the device

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.

An overview of the clinical trial

The trial, called SLATE (Stereotactic Laser Ablation for Temporal Lobe Epilepsy), aims to enroll 120 adults with drug-resistant MTLE. Participants will be treated using the Visualase(TM) device and followed for a period of one year after the procedure. Factors such as freedom from seizures, quality of life, adverse events and neuropsychological outcomes will be evaluated, in order to assess whether or not laser ablation is a viable therapeutical option for drug-resistant epilepsy.

More about surgery in epilepsy

Approximately one third of people with epilepsy are resistant to antiepileptic drugs (AEDs), and for a small proportion of these surgery to remove the area of the brain in which the seizures arise (the seizure focus) may be an option. However, these people need to undergo invasive assessments, which are unpleasant and may cause damage to other areas of the brain.

Being able to target the seizure focus in a minimally invasive way could have invaluable implications for people with drug resistant epilepsy.

Dr Michael Sperling, Professor of Neurology at Thomas Jefferson University in Philadelphia, said: "Surgery is an effective, though underused, treatment for drug-resistant epilepsy. For some patients, laser ablation offers a minimally-invasive treatment option," He added: "If demonstrated to be effective, results from this clinical trial will help clinicians weigh the risks and benefits of laser ablation when discussing treatment options with their patients."

Author: Dr Özge Özkaya