FDA approves clinical study to evaluate MRI-guided laser ablation for epilepsy

Medtronic (Dublin, Ireland) has received FDA approval for its Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE) study, which will support the expanded indication of the company's Visualase magnetic resonance imaging (MRI)-guided laser ablation technology for treating epilepsy in patients with drug-resistant mesial temporal lobe epilepsy (MTLE), the most common form of partial- or localization-related epilepsy.

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The Visualase MRI-guided laser ablation system is 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.

For some patients with drug-resistant epilepsy, laser ablation offers a minimally invasive treatment option, explains Michael Sperling, MD, Baldwin Keyes professor of neurology at Thomas Jefferson University and director of the Jefferson Comprehensive Epilepsy Center at Thomas Jefferson University Hospital (Philadelphia, PA). If the study demonstrates its effectiveness, results from this clinical trial will help clinicians weigh the risks and benefits of laser ablation when discussing treatment options with their patients, he says.

The study will include approximately 120 adult patients with drug-resistant MTLE treated at selected epilepsy centers across the U.S. 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.

For more information, please visit www.medtronic.com.