NeuroPace has announced that the Centers for Medicare & Medicaid Services (CMS) has approved New Technology Add-on Payments (NTAP) for the RNS system, the world’s only commercially available implantable closed-loop responsive neurostimulator system. The NTAP programme recognises new technologies that provide substantial clinical improvement over existing therapies, and is designed to support timely access to innovative technologies for Medicare beneficiaries.
NeuroPace received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the RNS system in November 2013. It is approved as a treatment for adults with partial onset seizures with one or two seizure onset zones whose seizures have not been controlled with two or more antiepileptic drugs.
“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,” says Frank Fischer, chief executive officer at NeuroPace. “Epilepsy centres have moved quickly since PMA approval to make the RNS system available. To date, 35 Comprehensive Epilepsy Centers that meet all the qualifications for the highest level of epilepsy care have completed required training and are able to implant the RNS system.”
Approximately 2.3 million adults in the United States have active epilepsy, and one-third live with seizures because existing therapies have not provided seizure control. Many people with uncontrolled seizures have or are eligible for Medicare disability benefits. Approval of the NTAP will significantly improve patient access to this new technology.
As a closed-loop system, the RNS System monitors the brain’s own signals, interprets those signals, provides stimulation when needed, and then assesses the brain’s response. The breakthrough aspect of the RNS system is its advanced detection and stimulation capabilities. This is unlike all other existing neurostimulation therapies, which continuously or intermittently stimulate the brain without determining the need for treatment or monitoring the response.
The RNS system has been evaluated in three clinical trials, including a prospective, randomised, double-blinded, sham stimulation controlled pivotal study. Results of the clinical trials demonstrate that the substantial clinical improvements experienced by patients over the short- and long-term are durable over many years of therapy. At this time, some patients have been treated with the RNS system for over ten years, and more than 1,500 patient years of experience with responsive neurostimulation have been accumulated to date.