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|Medtronic Expands Visualase(TM) MRI-Guided Laser Ablation System to European Markets with CE Mark Approval|
DUBLIN - April 10, 2018 - Medtronic plc (NYSE: MDT) announced today the CE (Conformité Européenne) Mark and European launch of the Visualase(TM) MRI-Guided Laser Ablation System. The Visualase system provides advanced MRI-guided laser ablation technology and can be used in neurosurgery procedures.
With the Visualase system, laser energy is delivered to the target area using an applicator. As light is delivered through the applicator, temperatures in the target area begin to rise, destroying the unwanted soft tissue1. Because Visualase procedures are guided by MRI images, the procedure can provide precise and controlled ablation. Due to the minimally invasive nature of the procedure, patients typically go home the next day.1-10
"The Visualase system will give neurosurgeons an additional minimally invasive option to precisely target and treat small areas of tissue," said Professor Jürgen Voges, M.D., from Magdeburg, Germany. "We are looking forward to offering this procedure to our patients."
The Visualase MRI-Guided Laser Ablation System received Food and Drug Administration (FDA) clearance in the United States in July 2007 to necrotize or coagulate soft tissue. Medtronic is currently involved in a pivotal SLATE (Stereotactic Laser Ablation for Temporal Lobe Epilepsy) study in the United States to support an expanded FDA indication for the treatment of epilepsy in patients with drug-resistant mesial temporal lobe epilepsy (MTLE), the most common form of partial or localization related epilepsy.
"After supporting the FDA clearance with our completion of the first in-human study of the Visualase system in 2006 in Paris, I am excited the technology has arrived in Europe," said Professor Alexandre C. Carpentier, neurosurgeon from Pitie Salpetriere university hospital, Greater Paris University Hospitals - AP-HP of Paris, France.
"The introduction of Visualase to European physicians ensures that more patients will have access to this beneficial technology," said Brett Wall, senior vice president and president of Medtronic's Brain Therapies division, which is part of the Restorative Therapies Group. "This latest milestone is a testament to our commitment to expanding therapeutic options for physicians and their patients."
To view an animation of the Visualase MRI-Guided Laser Ablation System in use, click here https://youtu.be/okpWbBVhZVE.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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