FDA Approval and Labeling*

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm510521.htm

Elias WJ, Lipsman N, Ondo WG, Ghanouni P, Kim YG, Lee W, Schwartz M, Hynynen K, Lozano AM, Shah B, Huss D, Dallapiazza RF, Gwinn R, Witt J, Ro S, Eisenberg HM, Fishman PS, Gandhi D, Halpern CH, Chuang R, Butts Pauly K, Tierney TS, Hayes MT, Cosgrove GR, Yamaguchi T, Abe K, Taira T, Chang JW., An International, Randomized, Controlled Trial of Focused Ultrasound Thalamotomy for Essential Tremor. The New England Journal of Medicine, Aug 2016.

FDA labeling: Exablate Neuro is intended for use in the unilateral thalamotomy treatment of idiopathic Essential Tremor patients age 22 or older with medication-refractory tremor.

Be sure to discuss with your physician all the risks involved with the Neuravive treatment.
Risks:
• For short periods of time during the treatment you may experience dizziness, pain or other sensations.
• There is the possibility that your tremor may return some months or years after treatment.
• There is a small risk that you could develop temporary or permanent muscle weakness, imbalance, and/or gait disturbance, sensory effects (tingling, numbness) in your fingers or elsewhere in your body.
• It is possible that your tremor may not improve.
• This procedure does not treat the underlying disease nor prevent the progression of the disease.

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