|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100026 / PAS001 |
| Date Original Protocol Accepted |
11/14/2013
|
| Date Current Protocol Accepted |
09/05/2014
|
| Study Name |
Continued F/u -Long Term Treatment (LTT)
|
| Device Name |
NEUROPACE RNS SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
The population enrolled included 57 subjects from the feasibility study and 173 subjects from the pivotal study, for a total of 230 subjects.
|
| Actual Number of Sites Enrolled |
The total number of sites enrolled in the study was 33.
|
| Patient Follow-up Rate |
A total of 70.4% of the enrolled population reached the study conclusion (162/230 subjects).
|
| Final Safety Findings |
As of the final data cutoff (May 1, 2018) 77% of the subjects in the LTT study had reported a serious adverse event (SAE) regardless of the relationship to the device (177/230 subjects). The most common categories of all SAEs were EEG monitoring (63 events in 19.1% of subjects; 44/230) and implant site infection (29 events in 11.3% of subjects, 26/230).
The SUDEP rate was calculated for the events that occurred while subjects’ neurostimulators were programmed to deliver responsive stimulation, and includes 5 deaths where SUDEP was determined to be “definite” or “probable.” Between the feasibility, pivotal, and LTT studies, these subjects accumulated 1895.2 patient implant-years, for a definite or probable SUDEP rate of 3.2 per 1000 patient implant-years.
The frequency of AEs was comparable to the incidence of AEs reported in the PMA. Whether device-related or not, 99.1% of subjects experienced at least one AE (229/230, 3128 total events). Of these, 56.1% of subjects experienced an event that was determined to be related to the device (129/230).
Reasons for explantation and analysis of devices returned revealed no concerns related to the device. There were no unanticipated adverse device effects (UADE) reported in the LTT study.
|
| Final Effect Findings |
The median percentage reduction in disabling seizures improves over time. After one year, the intent-to-treat (ITT) population experienced a median reduction of 31.5% (in 229 subjects), which increases to 75% at the end of nine years (in 178 subjects). The responder rate also improves over time. After one year, 33.2% of subjects were considered responders (76/229) increasing to 71% after nine years (117/178).
Compared to baseline, there were improvements over the entire 9-year follow-up in overall QOLIE and epilepsy-targeted and cognitive factors related subscales. In the mental health and physical health factors, the improvement observed in the first 2-4 years post-implant were not sustained, and returned to baseline over the 9-year period.
|
| Study Strengths & Weaknesses |
One hundred sixty-two subjects reached the protocol-defined completion of the LTT study, from an initially enrolled population of 230. These 162 subjects have at least nine years of experience with the system.
A study weakness is that subjects were able to modify antiepileptic medications; this PAS was not designed to evaluate the contribution of factors such as this to long term safety or effectiveness.
|
| Recommendations for Labeling Changes |
no
|
