Visualase MRI-Guided Laser Ablation System receives CE mark approval in Europe for neurosurgery.- Medtronic.
Medtronic announced the CE Mark and European launch of the Visualase 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 tissue. 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. The Visualase MRI-Guided Laser Ablation System received 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.