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  (Source: Fort Worth Star (left), NeuroPace (right))
Device will help the roughly two-fifths of epileptics

Epilepsy is a well-known disease that effects an estimated 3 million Americans, making it America's third most common neurological disorder, according to The Epilepsy Foundation, a patient advocacy group.

A pressing medical challenge is that even with treatment via common epilepsy drugs such as Tegratol or Oxtellar XR many epileptics still relatively experience dangerous seizures, albeit at a different rate.  Such so-called "severe epilepsy" or "drug-resistant epilepsy" cases account for roughly two out of every five epileptics -- or an estimated 1.2 million Americans.  An example of one public person suffering from this severe ailment is University of Minnesota coach Jerry Kill, who regularly has seizures that have caused him to miss football games.

Now a new device may offer relief.

Minnesota coach
Minnesota Div. I Football Coach Jerry Kill is among the Americans living with drug-resistant epilepsy
[Image Source: Getty Images]

The U.S. Food and Drug Administration (FDA) approved an electrode-implant this week for the treatment of severe epilepsy.  Designed by NeuroPace, Inc., the device impants neurostimulators into the skull, under the scalp.  The FDA describes the device stating that it consists of "one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain."

Neuropace Device
NeuroPace's stimulator [Image source: Fort Worth Star (left), NeuroPace (right)]

The device won't be able to treat everyone with severe epilepsy.  In a three-month randomized-control (where some patients are given a placebo non-functioning device) with 191 severe ("drug-resistant") epilepsy patients, only 29 percent of people with an implanted device turned on saw a 50 percent reduction in seizures.  In placebo group patients with the device implanted, but turned off, only 27 percent of patients saw that big a reduction.  Further average (38 percent) and mean (34 percent) reduction in the number of monthly seizures in the group with active devices were significantly higher than the average (17 percent) and median (19 percent) reductions in the control group.

Together these numbers illustrated that device was relatively effective in controlling seizures, but only in about 1 out of every 3 epileptics with drug-resistance.

Based on the FDA's numbers, this would suggest at least 348,000 Americans could experience relief from the implant, but by NeuroPace's reckoning that number might even be as high as 400,000 patients.

Tegratol
Common epilepsy drugs like Tegratol (pictured) are ineffective in as many as 400,000 epilepsy cases yearly in the U.S. [Image Source: GS/CVS]

Martha Morrell, MD, NeuroPace Chief Medical Officer and Clinical Professor of Neurology at Stanford University cheered the approval, stating:

The clinical community is eager for a new therapeutic option for patients who continue to suffer the devastating consequences of uncontrolled partial seizures.  The results of the pivotal study clearly demonstrate that the safety and efficacy of the RNS System is sustained over two years. Additional data about safety and efficacy beyond two years is being collected in a long-term follow-up study.

NeuroPace was founded in 1997 and is a small startup in Google Inc.'s (GOOG) hometown of Mountain View, Calif.  The biomedical firm focuses on therapeutic electrode implants.

Electrode therapy is a hot field.  Outside of epilepsy it's also Medtronic, Inc. (MDT) also offers FDA-approved electrode arrays as a form of pain control.  The electrode array have also been shown to be able to induce motions in patients with partial and full paralysis (a use that's thus far only approved in research trials, not for clinical use).  That success has raised hope that more advanced electrode arrays could potentially trigger a patient's autonomous reflexes to produce walking motions, patching the broken neural spinal circuit, so to speak.  Other electrode implants have been approved for use with inner-ear diseases.

Sources: FDA [press release], NeuroPace [press release; PDF]





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