US-based medical device manufacturer NeuroPace has received approval from the Centers for Medicare & Medicaid Services (CMS) for new technology add-on payments (NTAP) for its RNS System, an implantable closed-loop responsive neurostimulator system.
The RNS System is designed to treat partial onset seizures by detecting specific types of electrical activity in the brain through leads containing electrodes that are placed near the patient’s seizure focus or foci.
In November 2013, the US Food and Drug Administration (FDA) granted premarket approval (PMA) to NeuroPace as a treatment for adults with partial onset seizures and one or two seizure onset zones, where seizures have not been controlled with two or more antiepileptic drugs.
NeuroPace CEO Frank Fischer said: "We are grateful CMS recognises the substantial benefits the RNS System has provided to patients and the need for patients who suffer from uncontrolled seizures to have access to this therapy.
"Epilepsy centres have moved quickly since PMA approval to make the RNS System available.
"To date, 35 comprehensive epilepsy centres that meet all the qualifications for the highest level of epilepsy care have completed required training and are able to implant the RNS System."
In the US, approximately 2.3 million adults have active epilepsy, and one-third live with seizures as the current therapies have not provided seizure control.
The closed-loop RNS System monitors the brain’s signals, interprets those signals, provides stimulation when needed and then evaluates the brain’s response.
Advanced detection and stimulation capabilities are the breakthrough features of the RNS System.
The system has been assessed in three clinical trials, including a prospective, randomised, double-blinded, sham stimulation controlled pivotal study.
Results show that the substantial clinical improvements experienced by patients over the short and long-term are durable over many years of therapy.