The U.S. Food and Drug Administration has approved Medtronic plc’s Investigational Device Exemption (IDE) application for its pivotal Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE) study.
The clinical investigation is designed to support the expanded indication of the currently marketed Visualase MRI-guided laser ablation technology for treatment of epilepsy in patients with drug-resistant mesial temporal lobe epilepsy (MTLE), the most common form of partial or localization related epilepsy.
The Visualase system is 510(k) cleared by the FDA to necrotize or coagulate soft tissue in neurosurgery and other surgical specialties. Through a minimally invasive procedure, laser energy is delivered to the target area using a laser applicator. As light is delivered through the laser applicator, temperatures in the target area begin to rise, coagulating the unwanted soft tissue under real-time MRI guidance.
The study will include approximately 120 adult patients with drug-resistant MTLE treated at selected 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.
Approximately three million people in the U.S. have epilepsy, and it is estimated that at least one-third become drug resistant, continuing to have seizures regardless of the number or type of anti-epileptic drugs used.
“Surgery is an effective, though underused, treatment for drug-resistant epilepsy,” Michael Sperling, MD, director of the Jefferson Comprehensive Epilepsy Center at Thomas Jefferson University Hospital in Philadelphia, said. “For some patients, laser ablation offers a minimally-invasive treatment option. 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.”
