Not for publication in the USA
Siemens Healthineers, a leader in medical technology and diagnostic and therapeutic imaging, and INSIGHTEC®, a global medical technology innovator of incisionless surgery, today 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, MD, 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. 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, Ph.D., Head of Magnetic Resonance at Siemens Healthineers. “The cooperation with INSIGHTEC is the latest example of our open innovation strategy. Through close collaboration with clinical experts and partner companies we make great strides in expanding precision medicine.”
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. CUN is renowned academic institution with a history of innovative research and clinical treatment for neurological movement disorders. “Focused ultrasound is a highly precise, yet minimally invasive procedure for treating essential tremor,” commented Dr. 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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