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INSIGHTEC Submits Pre-market Approval to Japanese PMDA of MR-guided Focused Ultrasound Surgery for Treatment of Parkinson’s Disease

INSIGHTEC®, is a global medical technology innovator of incisionless surgery. Today they announced that it has submitted a Pre-Market Approval (PMA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for its Exablate Neuro™ (Exablate 4000) device for treating advanced Parkinson’s Disease patients suffering from mobility, rigidity or dyskinesia effects.

The Exablate Neuro, which uses focused ultrasound together with MR imaging to treat deep within the brain with no incisions, is intended to improve motor function and reduce dyskinesia. Dyskinesia is one of the debilitating symptoms that presents as uncontrolled, involuntary movement of the arms and/or legs. Dyskinesia often occurs as a side effect of medication in Parkinson’s Disease patients.

“INSIGHTEC is committed to supporting research that extends the applications and potential of focused ultrasound, to improve the lives of people living with Parkinson’s disease with a much less invasive approach than conventional surgery,” commented Maurice R. Ferré MD, INSIGHTEC’S CEO and Chairman of the Board of Directors.

The Exablate Neuro is currently approved by MHLW to treat medication-refractory essential tremor. There are currently seven medical institutions in Japan performing the incisionless focused ultrasound treatment for essential tremor on a routine basis.

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