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ROCHESTER, Minn. — People with epilepsy may have a new high-tech way to manage hard-to-control seizures. A new implantable medical device that delivers responsive neurostimulation has been approved by the U.S. Food and Drug Administration. The technology is designed to detect abnormal activity in the brain and respond and deliver subtle levels of electrical stimulation to normalize brain activity before an individual experiences seizures. The treatment is available at all Mayo Clinic sites.
MULTIMEDIA ALERT: For audio and video of Dr. Joseph Sirven talking about the device, visit the Mayo Clinic News Network.
Mayo Clinic in Arizona, Florida and Minnesota were all involved in the clinical trials for the device (and have collectively enrolled the highest number of patients into the trials).
The device is indicated for use as an adjunctive therapy in reducing the frequency and severity of seizures in people 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than two epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures).
According to NeuroPace, Inc., makers of this new NeuroPace® RNS® System, safety and effectiveness have been demonstrated in patients who average three or more disabling seizures per month over the three most recent months (with no month with fewer than two seizures). However, it has not been evaluated in patients with less frequent seizures. It is estimated that about 400,000 people in the U.S. meet these criteria and may benefit from treatment with the RNS System.
To interview a Mayo Clinic expert about the medical device e-mail email@example.com or call 507-284-5005.
Mayo Clinic receives research support from NeuroPace and Dr. Richard Zimmerman receives consulting fees as a member of their Medical advisory board.
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