FDA OKs epilepsy trial for MDT’s Visualase MRI-guided laser

Medtronic (NYSE:MDT) said today that the FDA granted an investigational device exemption for a clinical trial of its Visualase ablation device in treating temporal lobe epilepsy. Fridley, Minn.-based Medtronic put $105 million on the table for Houston-based Visualase back in 2014, including $70 million in up-front cash and another $35 million in milestones. Medtronic had a stake in Visualase and its MRI-guided laser ablation device. Today the company said the Slate trial is aimed at expanding the indication for Visualase to include drug-resistant mesial temporal lobe epilepsy. The 120-patient trial is designed to track outcomes for a year after the procedure, including freedom from seizure, quality of life, neuropsychological measures and adverse events, Medtronic said. “Uncontrolled seizures lead to a wide variety of medical consequences and can have significant lifestyle and psychosocial impacts,” neurosurgery general manager Scott Hutton said in prepared remarks. “We’re hopeful that people with drug-resistant MTLE can benefit from our innovative Visualase technology.” “Surgery is an effective, though underused, treatment for drug-resistant epilepsy. For some patients, laser ablation offers a minimally-invasive treatment option,” added Dr. Michael Sperling of Philadelphia’s Thomas Jefferson University Hospital. “If demonstrated to be effective, results from this clinical trial will help clinicians weigh the risks a...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Neurological Surgical Laser/Light-based Devices Medtronic Visualase Source Type: news