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Medtronic Visualase System Used in Mayo Clinic Epilepsy Trial

BioPhotonics
Apr 2017
DUBLIN — Medical technology developer Medtronic PLC has announced that its Visualase MRI-guided laser ablation system has been performed in the Stereotactic Laser Ablation for Temporal Lobe Epilepsy (SLATE) clinical trial at the Mayo Clinic in Rochester, Minn.

Visualase technology works with MRI images for the precise destruction of the target.
Visualase technology works with MRI images for the precise destruction of the target. Courtesy of Medtronic.

The SLATE trial is designed to support the expanded indication of the Visualase system for the treatment of patients with drug-resistant mesial temporal lobe epilepsy (MTLE), the most common form of partial or localization-related epilepsy. The Visualase 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, destroying the unwanted soft tissue under real-time MRI guidance.

"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," said Dr. Robert Gross, co-principal investigator of the trial and Emory University MBNA/Bowman professor of neurosurgery and director of the functional, stereotactic and epilepsy surgery division.

Approximately three million people in the U.S. have epilepsy, with MTLE being the most common form of partial or localization-related epilepsy. It is estimated that at least one-third of MTLE patients become drug resistant, continuing to have seizures regardless of the number or type of anti-epileptic drugs used.

Visualase MRI-Guided Laser Ablation technology is used to necrotize or coagulate soft tissue in neurosurgery and other surgical specialties.
Visualase MRI-Guided Laser Ablation technology is used to necrotize or coagulate soft tissue in neurosurgery and other surgical specialties. Courtesy of Medtronic.

During the clinical trial, 120 adult patients with drug-resistant MTLE will be treated at selected epilepsy centers across the U.S such as Emory University, the Mayo Clinic, Northwell Health, Thomas Jefferson University Hospital and the University of Miami Health System. After the Visualase procedure, subjects will be followed for 12 months and evaluated for freedom from seizures, quality of life, adverse events and neuropsychological outcomes.

"The SLATE study is an example of Medtronic's commitment to conduct rigorous clinical research in partnership with physicians and providers,” said Brett Wall, senior vice president and president of Medtronic's brain therapies division. “Such collaborations offer the opportunity to better serve patients through the development and analysis of new technologies and indications. A study such as SLATE offers the opportunity to gather clinical evidence that can help us transform the way epilepsy is treated."

Medtronic is a developer of medical technology, services and solutions for the health industry.

MedtronicVisualaseMayo ClinicepilepsySLATEStereotactic Laser Ablation for Temporal Love Epilepsyclinical trialAmericasBusinessbiophotonicslasersRapidScan

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