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FDA Labeling

https://www.insightec.com/media/31393/exablateneuroinformationforprescribers0usa.pdf

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.


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