Tolerability
In the pivotal study, none of the measured neuropsychological measures deteriorated. Rather, there were significant group improvements in verbal functioning, visuospatial ability, and memory at the end of 1 and 2 years (P < .05). Quality of life also improved (P < .02). Adverse events included intracranial hemorrhage in 9 of 191 (4.7%) patients, 6 of which occurred postoperatively (3 epidural hematomas, 2 intraparenchymal hemorrhages, and 1 subdural hematoma). Furthermore, 3 subdural hematomas were the result of seizure-related head trauma. None of these hemorrhages had permanent neurologic sequelae. Ten patients (5.2%) had soft tissue implant or incision site infections. Four patients required device explant. During the study, 6 patients died (4 sudden unexpected deaths in epilepsy [SUDEP], 1 lymphoma, and 1 suicide).
A Quantum Leap for Epilepsy Treatment
The NeuroPace RNS System is the second medical device approved for the treatment of intractable epilepsy and represents a quantum technological leap over the VNS. This new device will be appropriate for patients who would be considered for epilepsy surgery but, for one reason or another (too many epileptic foci, epileptic focus in eloquent areas, patient preference), are not good surgical candidates. Although 6 patients died during the study, none of these deaths appeared to be related to the device. Indeed, 4 of the deaths were classified as SUDEP, likely a result of intractable epilepsy, further emphasizing the urgency of aggressive attempts at seizure control. Available data suggest that the NeuroPace RNS System's antiepileptic activity is sustained or even improves with time. The FDA approval of the NeuroPace RNS System represents an important new option for the treatment of intractable partial seizures. How well this closed-loop responsive cortical stimulator functions in the "real world" of epilepsy patients remains to be seen.