The U.S. Food and Drug Administration (FDA) has approved a clinical trial for Medtronic’s Visualase laser-ablation system for people with drug-resistant mesial temporal lobe epilepsy (MTLE), a condition marked by seizures not treated effectively with antiseizure therapy.
Visualase is a MRI-guided technology in which laser energy is delivered to the target area with a laser applicator. As light is delivered through the applicator, temperatures in the target area begin to increase and unwanted tissue is destroyed.
“This is a significant step in collecting evidence regarding laser ablation as a treatment option for MTLE. We are eager to begin enrolling patients,” said Dr. Robert Gross, professor of Neurosurgery at Emory University, in Atlanta, in a press release.
Visualase surgeries are guided by MRI images. The procedure can provide precise ablation in a minimally invasive manner which reduces hospital stays.
The FDA already cleared the system to coagulate or kill soft tissue in brain surgeries or other specialized procedures. The trial will be the first time the procedure will be tried on people with epilepsy.
The Slate (Stereotactic Laser Ablation for Temporal Lobe Epilepsy) clinical trial will include 120 adult patients with drug-resistant MTLE treated at certain epilepsy centers across the United States. After the Visualase procedure, patients will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events and neuropsychological outcomes.
About one-third of patients with epilepsy are resistant to antiepileptic drugs (AEDs). For a few patients, surgery to remove the area of the brain in which the seizures arise is possible. But the patients need to undergo invasive clinical evaluations, which may cause damage to other brain areas.
Targeting the seizure focus in a minimally invasive manner could benefit patients with MTLE.
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,” Sperling said. “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.”