Patient selection

Determining Candidates for Activa® Therapy

Activa Parkinson's Control Therapy may be appropriate for patients who

• Are diagnosed with advanced, levodopa-responsive, idiopathic Parkinson's disease, and
• Have symptoms that are insufficiently controlled by pharmacotherapy, and
• Have motor symptoms that present a significant functional disability.

Patient Selection Guidelines for Activa® Parkinson's Control Therapy

Activa Parkinson's Control Therapy is used for patients
	Who suffer from advanced Parkinson's disease. Patients should be carefully screened for other movement disorders, which may not respond to Activa Therapy.
	Who have been shown to benefit from levodopa therapy. Activa Therapy has not been shown to improve symptoms that do not also respond to levodopa.
	Whose symptoms are not (or are no longer) adequately controlled by medications.

General Considerations for Patient Selection
	The patient must be an appropriate candidate for stereotactic procedures. The patient must be physically able to undergo 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 when appropriate be able to operate the Access Therapy patient Controller.
	The patient must be available for periodic follow-up visits.

Use in Specific Populations
The safety and effectiveness of this therapy has not been established for patients with the following:
	Neurological disease origins other than idiopathic Parkinson's disease
	Previous surgical ablation procedure
	Pregnancy
	Dementia
	Coagulopathies
	Moderate to severe depression
	Patients under the age of 18 years
	Patients over the age of 75 years

Activa Tremor Control Therapy may be appropriate for patients whose

• Disabling tremor of the upper extremity is due to essential tremor or Parkinson's disease.
• Tremor constitutes a significant functional disability.
• Tremor is refractory to pharmacological therapies.

Patient Selection Guidelines for Activa® Tremor Control Therapy

Activa Tremor Control Therapy is used for patients
	Who have disabling tremor of the upper extremity due to essential tremor or Parkinson's disease.
	Who have tremor that is uncontrolled with medication (residual disabling tremor or intractable side effects persist).
	Whose tremor constitutes a significant disability as determined by both the physician and patient.

General Considerations for Patient Selection
	The patient must be an appropriate candidate for stereotactic procedures. The patient must be physically able to undergo 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 when appropriate be able to operate the Access Therapy patient Controller.
	The patient must be available for periodic follow-up visits.

Use in Specific Populations
The safety and effectiveness of this 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 or delivery
	Patients under the age of 18 years
	Patients over the age of 80 years

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