Intended Use:

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

The FDA labeling has been extended as follows to include tremor-dominant Parkinson's disease.

Exablate Neuro is intended in the unilateral Thalamotomy (ventralis intermedius) treatment of Tremor-dominant Parkinson’s Disease with medication-refractory tremor.  Patients must be at least age 30. 

Risks:

Be sure to discuss with your physician all the risks involved with the focused ultrasound treatment.

Risks associated with thalamotomy include transient and/or permanent sensory paresthesias, numbness, imbalance, and/or gait disturbance. Risks and adverse events also associated with the Exablate Neuro treatment include sonication-related pain, sonication-related dizziness or nausea or potential for deep vein thrombosis associated with 3-4 hours on the treatment bed.

• 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.

Information for Prescibers  

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.

Aaron E. Bond, MD, PhD; Binit B. Shah, MD; Diane S. Huss, DPT, NCS; Robert F. Dallapiazza, MD, PhD; AmyWarren, MS; Madaline B. Harrison, MD; Scott A. Sperling, PsyD; Xin-QunWang, MS; Ryder Gwinn, MD; Jennie Witt, MD; Susie Ro, MD;W. Jeffrey Elias, MD. Safety and Efficacy of Focused Ultrasound Thalamotomy for Patients With Medication-Refractory, Tremor-Dominant Parkinson Disease. A Randomized Clinical Trial. JAMA Neurology 2017;74(12):1412-1418.

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