|The RNS device receiced FDA approval via the PMA pathway.|
NeuroPace (Mountain View, CA) landed FDA PMA approval for its RNS Stimulator, a device that can detect and treat patients suffering from drug-resistant epilepsy.
Seizures occur when neurons in a patient's brain fire in abnormally. The company's device detects these signals and emits an electrical change through implanted wires to stop the seizure from occurring.
Implanted medical devices for the treatment of epilepsy are not new. For example, implants are used to treat conditions like dystonia and Parkinson's disease. Another class of devices utilize vagal nerve stimulation for the treatment of some types of epilepsy. However, the RNS Stimulator is not the same as traditional VNS devices. With RNS, seizures can be detected and prevented at the source.
While the device demonstrated efficacy in clinical trials, some patients had infections at the implantation site.
"We believe the RNS System has the potential to provide substantial improvement in quality of life to hundreds of thousands of people diagnosed with epilepsy in the U.S. who are unable to achieve seizure control with medications," stated Frank Fischer, CEO of NeuroPace. "We anticipate that physicians will be able to make this breakthrough therapy available to eligible patients in the very near future."