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26 Feb 2013

FDA panel approves RNS System for epilepsy treatment

FDA expert panel gives its backing to new device for treatment of epilepsy

A new implant device for the treatment of epilepsy has been unanimously approved by an FDA Advisory Panel by 11 to zero.

The experts claimed that the clinical benefits of the NeuroPace RNS System – which is designed for treatment of medically refractory partial epilepsy – outweigh any risks of its use.

Neuropace is currently seeking approval for the system in the treatment of adults with partial onset seizures that have not responded to two or more anti-epileptic drugs.

Although the FDA is not bound to the decision of its advisory panels, it is usually the case that the regulatory body agrees with these experts.

The RNS System, which involves implanting electrodes into parts of the brain where irregular electrical activity can lead to seizures, has already been evaluated in three clinical trials.

Frank Fischer, NeuroPace chief executive, said: "We have worked for over 15 years to develop and clinically evaluate the RNS System.

"We are very excited that patients and physicians who need new treatment options so desperately are now likely to have the RNS System commercially available in the near future."

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