Overview of Activa Dystonia Therapy

Activa Dystonia Therapy received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration in April 2003 as an aid in the management of chronic, intractable (drug refractory) primary dystonia. Applicable categories of primary dystonia include generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis). The therapy is approved for patients who are seven years of age and older.

Activa Dystonia Therapy delivers electrical stimulation bilaterally or unilaterally to targeted cells in the internal globus pallidus (GPi) or subthalamic nucleus (STN).^1,2,3 The stimulation can be adjusted via telemetry with the physician programmer to meet each patient's needs.

The FDA’s HDE ruling is based on the Agency’s decision that Activa Dystonia Therapy’s probable health benefits outweigh the risks of injury or illness from its use, that no comparable device is available to treat the disease, and that fewer than 4,000 individuals are affected each year in the United States.

Activa Dystonia Therapy is limited to use in implanting centers that receive Institutional Review Board approval for the procedure.

The safety and effectiveness of Activa Dystonia Therapy have not been established through a full Pre-Market Approval (PMA) study.

Activa Dystonia Therapy

A surgically implanted neurostimulator, similar to a cardiac pacemaker, delivers electrical stimulation bilaterally or unilaterally to precisely targeted areas on either or both sides of the brain to manage the disabling symptoms of primary dystonia.

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References

1. Abosch A. and Lozano A, Stereotactic neurosurgery for movement disorders. Can J Neurol Sci, 2003. 30(Suppl 1): p. S72-S82.
2. Bereznai, B., et al., Chronic high-frequency globus pallidus internus stimulation in different types of dystonia: a clinical, video, and MRI report of six patients presenting with segmental, cervical, and generalized dystonia. Mov Disord, 2002. 17(1): p. 138-44.
3. Coubes, P., et al., Treatment of DYT1-generalized dystonia by stimulation of the internal globus pallidus. Lancet, 2000. 355(9222): p. 2220-2221.

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