Medtronic (NYSE:MDT) said today that the 1st procedure using the Visualase MRI-Guided laser ablation system has been performed in its SLATE clinical trial evaluating the device in patients with drug-resistant mesial temporal lobe epilepsy.
The trial is slated to enroll 120 patients with MTLE, the most common form of epilepsy. Researchers will observe the patients for 12 months following the procedure and evaluate them for freedom from seizures, quality of life, adverse events and neuropsychological outcomes.
Fridley, Minn.-based Medtronic said that at least 1/3 of MTLE patients become drug resistant, meaning they will continue to have seizures even if they use anti-epileptic drugs.
“We’re excited about this important milestone and look forward to continued recruitment in this study – which will determine the utility of the technology as a surgical treatment for patients with drug-resistant MTLE,” co-principal investigator Dr. Michael Sperling said in prepared remarks.
“The data collected in this study will allow a comprehensive evaluation of the risks and benefits of the device in this new indication, ensuring that treating physicians are well-informed about its use,” co-principal investigator Dr. Robert Gross added.
The Visualase MRI-Guided laser ablation system is approved by the FDA to coagulate soft tissue in neurosurgery and other surgical specialties. The device delivers laser energy to the targeted area, destroying unwanted soft tissue using real-time MRI guidance.
“The SLATE study is an example of Medtronic’s commitment to conduct rigorous clinical research in partnership with physicians and providers. Such collaborations offer the opportunity to better serve patients through the development and analysis of new technologies and indications,” Medtronic’s brain therapies division senior VP & president Brett Wall said. “A study such as SLATE offers the opportunity to gather clinical evidence that can help us transform the way epilepsy is treated.”