FDA Approval: Medtronic Deep Brain Stimulation for Medically Refractory Epilepsy

FDA News
Tuesday, May 1, 2018

The U.S. Food and Drug Administration (FDA) granted approval for the use of Deep Brain Stimulation (DBS) therapy by Medtronic as add-on treatment for focal epilepsy. It is being approved for use in the following people:

What is DBS?

DBS therapy consists of a thin wire with electrodes at the tip that is implanted into a target area in the brain. A neurostimulator device is placed under the skin of the collarbone. The neurostimulator can be programmed to deliver small electrical pulses to a particular area of the brain to help stop or lessen the number of seizures. The target area of the brain used in DBS is called the anterior nucleus of the thalamus (ANT). This brain area is an important part of a network involved in many seizures types.

DBS has been used to treat epilepsy in other countries. It has also been used widely in the U.S. and other countries to treat symptoms of essential tremor, Parkinson’s disease, and a variety of psychiatric disorders.

How well does it work?

DBS has been studied in the U.S. for many years, including 7 years of long-term follow-up of people who participated in a controlled clinical trial.

  • In the controlled trial, total number of seizures decreased on average after 3 months by 40% in people treated with DBS as compared to only 15% for those in a placebo group (not receiving DBS).
  • People receiving DBS for long-term follow-up (up to 7 years) had seizures decrease by 75%.
  • Seizure severity and quality of life improved significantly from baseline to year 7 after DBS was implanted. Some measures of cognitive function improved and no significant worsening in cognition or depression were seen.

What does this mean?

Despite epilepsy surgery and other neurostimulation devices, many people continue to have uncontrolled epilepsy.

“This is such exciting news for the epilepsy community,” said Dr. Joseph Sirven, editor-in-chief of epilepsy.com and professor of neurology at Mayo Clinic Arizona. “More options and more choices for people suffering with drug resistant epilepsy will soon be available with the addition of DBS.”

DBS for epilepsy will be one of the surgical therapies offered at most Level 4 Comprehensive Epilepsy Centers.

References

  1. Fisher RS, et al. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia. 2010 May; 51(5):899-908 
  2. Salanova V, et al. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology. 2015 Mar10; 84(10):1017-25. 
  3. Sandok E, et al. Long term outcomes of the SANTE Trial: 7-Year Follow-Up. American Epilepsy Society Annual Meeting. 2016 Abst. 1.298. 
  4. Tröster AI, et al. Memory and mood outcomes after anterior thalamic stimulation for refractory partial epilepsy. Seizure. 2017 Feb; 45:133-141.  
Authored by: Patty Osborne Shafer RN MN | Associate Editor/Community Manager on 5/2018
Reviewed by: Mohamad Koubeissi MD | Surgery and Devices Editor on 5/2018

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