InSightec receives CE Mark for Exablate Neuro for Siemens Healthineers MRI scanners


New magnetic resonance imaging (MRI) compatibility holds potential to expand patient access around the world to incisionless brain surgery. Siemens Healthineers and InSightec have announced the CE clearance of Exablate Neuro compatible with Magnetom Skyra, Prisma and Prisma Fit scanners from Siemens Healthineers. Exablate Neuro uses focused ultrasound for treatments deep within the brain with no surgical incisions. MR imaging provides a complete anatomical survey of the treatment area, patient-specific planning and real-time outcome monitoring throughout the treatment.

“InSightec and Siemens Healthineers are working in partnership to transform patient care,” said Maurice R Ferré, InSightec chief executive officer and chairman of the board. “This milestone is key to expanding patient access to incisionless brain surgery using focused ultrasound.” The CE mark includes approval for treatment of medication-refractory essential tremor, tremor-dominant Parkinson’s disease and neuropathic pain. Food and Drug Administration (FDA) approval for the Exablate Neuro compatibility with MRI scanners from Siemens Healthineers to treat medication-refractory essential tremor was received on October 1, 2018. “We welcome a new era of advanced MRI-guided therapy in the neuro space,” said Arthur Kaindl, head of magnetic resonance at Siemens Healthineers.

Clínica Universidad de Navarra (CUN) in Pamplona, Spain is the first institution in Europe to successfully treat patients with Exablate Neuro compatible with MRI scanners from Siemens Healthineers. “Focused ultrasound is a highly precise, yet minimally invasive procedure for treating essential tremor,” commented Jorge Guridi, head of neurosurgery department of Clínica Universidad de Navarra. “This presents a major opportunity for improvement in quality of life for a large group of patients who do not want traditional open surgery.”


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