Selecting Patients for Activa Tremor Control Therapy

General Considerations for Patient Selection

• The patient must be an appropriate candidate for stereotactic procedures.
• The patient must be physically able to endure the surgical procedure, and must be able to cooperate by answering questions and following directions during the surgery.
• Patients with significant cognitive decline or dementia are not typically considered for Activa implant surgery.
• The patient must understand the nature of the therapy and be able to operate the neurostimulator Control Magnet or Therapy Controller.
• The patient must be available for periodic follow-up visits.
  

Use in Specific Populations

The safety and effectiveness of Activa Tremor Control Therapy has not been established for patients with the following:

• Bilateral thalamic stimulation
• Neurological disease origins other than essential tremor or Parkinson’s disease
• Previous thalamotomy or surgical ablation procedure
• Pregnancy
• Patients under the age of 18 years
• Patients over the age of 80 years

Refer to the Activa Therapy Clinical Summary for more detailed information.

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