Medtronic's new surgical device earns FDA clearance for use in epilepsy clinical trial

Minneapolis-based Medtronic announced Friday that the Food and Drug Administration approved its MRI-guided laser ablation technology for use in a study regarding epilepsy.

Visualase is currently approved by the FDA for use to necrotize or coagulate soft tissue in neurosurgery and other special surgeries. The new clinical trial aims to verify the expansion of this technology for treatment of patients with drug-resistant mesial temporal lobe epilepsy.

The study will include about 120 adults with drug-resistant MTLE who are treated at epilepsy centers across the U.S. After patients undergo a procedure with Visualase, researchers will follow them for 12 months to evaluate freedom from seizures, quality of life, adverse events and neuropsychological outcomes.

"Surgery is an effective, though underused, treatment for drug-resistant epilepsy. 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," said Michael Sperling, MD, professor of neurology at Thomas Jefferson University and director of the Jefferson Comprehensive Epilepsy Center at Thomas Jefferson University Hospital in Philadelphia.

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