NeuroPaceBrain Stimulation for Seizures <br />Myeshi Briley,HS-BCP<br />
About NeuroPaceNeuroPace was founded to design, develop, manufacture and market implantable devices for the treatment of n...
MOUNTAIN VIEW, CA - July 8, 2010 — NeuroPace, Inc. today announced that it has submitted its Premarket Approval (PMA) appl...
NeuroPace Submits PMA Application for FDA Approval of Novel Investigational Device for EpilepsyPivotal Trial Data Demonstr...
"The clinical data support that this unique technology can provide an effective method to significantly reduce seizure fre...
http://www.neuropace.com/about/news/20100708.html<br />Reference:<br />
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Neuropace brain stimulation for seizures

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Neuropace Myeshi Briley,HS-BCP

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Neuropace brain stimulation for seizures

  1. 1. NeuroPaceBrain Stimulation for Seizures <br />Myeshi Briley,HS-BCP<br />
  2. 2. About NeuroPaceNeuroPace was founded to design, develop, manufacture and market implantable devices for the treatment of neurological disorders by responsive brain stimulation. The company's initial focus is the treatment of epilepsy, a debilitating neurological disorder affecting approximately one percent of the population worldwide. An estimated 30-40 percent of the 50 million people worldwide (including more than 3 million Americans) experience uncontrolled seizures. In addition to treating epilepsy, responsive neurostimulation holds the promise of treating several other disabling medical disorders that impact the quality of life for millions of patients around the world. <br />NeuroPace<br />
  3. 3. MOUNTAIN VIEW, CA - July 8, 2010 — NeuroPace, Inc. today announced that it has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its RNS® System, a novel investigational device that utilizes responsive neurostimulation to monitor and interrupt abnormal electrical activity in the brain before seizures occur. The PMA application is for an indication to treat people with medically refractory partial onset epilepsy originating from one or two locations in the brain. Partial onset epilepsy is a common form of the disorder that is difficult to treat with medication. Results from the company's pivotal trial were included in the PMA application. The data, some of which were presented at the American Epilepsy Society's (AES) 63rd Annual Meeting in December 2009, were collected from 191 people with medically refractory partial onset epilepsy enrolled at 31 sites located in the United States. The results demonstrate the RNS System significantly reduced the frequency of disabling seizures. <br />NeuroPace<br />
  4. 4. NeuroPace Submits PMA Application for FDA Approval of Novel Investigational Device for EpilepsyPivotal Trial Data Demonstrate RNS System Met Primary Endpoints by Significantly Reducing Seizures with Positive Safety Profile<br />MOUNTAIN VIEW, CA - July 8, 2010 — NeuroPace, Inc. today announced that it has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its RNS® System, a novel investigational device that utilizes responsive neurostimulation to monitor and interrupt abnormal electrical activity in the brain before seizures occur. The PMA application is for an indication to treat people with medically refractory partial onset epilepsy originating from one or two locations in the brain. Partial onset epilepsy is a common form of the disorder that is difficult to treat with medication. Results from the company's pivotal trial were included in the PMA application. The data, some of which were presented at the American Epilepsy Society's (AES) 63rd Annual Meeting in December 2009, were collected from 191 people with medically refractory partial onset epilepsy enrolled at 31 sites located in the United States. The results demonstrate the RNS System significantly reduced the frequency of disabling seizures. <br />NeuroPace<br />
  5. 5. "The clinical data support that this unique technology can provide an effective method to significantly reduce seizure frequency with a positive safety profile for people with partial onset epilepsy," said David Roberts, MD, Chief of Neurosurgery at Dartmouth-Hitchcock Medical Center. "Epilepsy is an extremely challenging disorder to treat and despite our best efforts, there is a large population of people who do not respond well to the currently available treatment options. The RNS System has the potential to meaningfully improve quality of life for many people who are currently living with uncontrollable seizures." <br />The RNS System continuously monitors brain electrical activity and, after identifying a preprogrammed abnormal pattern, delivers brief and mild electrical stimulation with the intention of suppressing the seizure before symptoms occur. <br />"The RNS System is the world's first responsive neurostimulation system," said Frank Fischer, CEO of NeuroPace. "We look forward to working with the FDA during the review process, and firmly believe the RNS System has the potential to provide an invaluable additional treatment option for people living with epilepsy." <br />NeuroPace<br />
  6. 6. http://www.neuropace.com/about/news/20100708.html<br />Reference:<br />
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