f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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New Enrollment -Performance & Programming


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P100026 / PAS003
Date Original Protocol Accepted 11/14/2013
Date Current Protocol Accepted 09/28/2020
Study Name New Enrollment -Performance & Programming
Device Name NEUROPACE RNS SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Objectives
The primary safety objective is to characterize the annual serious adverse event (SAE) rate over 5 years in patients treated with the RNS System.
The primary effectiveness objective is to demonstrate the median percent reduction in disabling seizures from baseline (3 months pre-implant) to 3 years in the PAS, and evaluate if this reduction is comparable to the median percent reduction in seizures from baseline to 3 years in the LTT controlled clinical study.
The secondary safety objective is to demonstrate that there is not a worsening in seizures over time in patients treated with the RNS® System beginning at 6 to 12 months post implant and extending to 3 years.
Additional objectives include characterizing, describing, and evaluating:
Patient characteristics
Adverse events of particular relevance
All-cause mortality
Anti-epileptic drug (AED) use
Subject disposition
RNS System explant/revision
Sudden unexpected death in Epilepsy (SUDEP) rate
Median percentage change
Responder rate
Seizure frequency
in sub-populations of subjects treated with the RNS® System.
Programming-related:
The primary safety objective is to demonstrate that there is no difference in safety in the 6-week perioperative period based on the experience of NeuroPace qualified and trained implanting physicians.
The co-primary safety objective is to demonstrate that there is no difference in safety 1 year post implant on the experinece of NeuroPace qualified and trained treating physicians and Comprehensive Epilepsy Centers.
The primary effectiveness objective is to demonstrate that the stimulation programming classes have similar effects on the overall seizure frequency.
The secondary objective is to characterize the effects of the stimulation programming classes on the overall 5 year rate of SAEs and device related non serious AEs.
Design:
A 5 year, non randomized open label prospective observational study in newly implanted patients treated with the RNS system.
Study Population The study population will consist of individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to 2 or more antiepileptic medications, and currently have frequent and disabling seizures.
Sample Size Sample size:
Up to 375 subjects may be enrolled from up to 30 sites in order that a minimum of
300 subjects be implanted, with no individual investigational site implanting more than 15 subjects.
Assumptions:
The sample size calculation is based on the endpoint related to the secondary safety objective (seizure worsening) Sample size calculation for a regression model with a log link and including a term for linear slope in the dependent variable indicates that 240 patients will provide over 80% power for the ability to detect a possible slope equivalent to a 20% cumulative increase in seizures over the period from pre-implant to 30 to 36 months post-implant. The sample size calculation assumes a linear regression t test of the slope with a one sided alpha of 0.05, and a standard deviation of 0.28 applicable to the term for linear slope. Conservatively assuming approximately 25% of patients do not contribute the full 3 years of data leads to selection of 300 implanted patients as the sample size.
Key Study Endpoints Primary Safety Endpoint: SAE rate; Secondary Safety Endpoins: Seizure worsening
Primary effectiveness endpoint: Median percent reduction in seizures
Programming-related endpoints:
Primary Safety Endpoint - Neurosurgeon Experience
Primary Safety Endpoint - Physician Experience
Primary Effectiveness Endpoint - Neurostimulator Programming
Secondary Safety Endpoint - Neurostimulator Programming
Follow-up Visits and Length of Follow-up 5 years
Patients will be followed through 5 years with assessments at 15 days, 1 month, 3 months, 6 months, 9 months, 12 months, and then every 4 months until 60 months upon conclusion of the study.
Interim or Final Data Summary
Interim Results As of October 1, 2020, a total of 316 subjects have been implanted for a mean of 708.6 days (range: 1.5 to 1806.5 days). There were no unanticipated adverse device events (UADE = unanticipated device related SAE) reported from the first study implant through the
database closure date for this report. More comprehensive safety data and overall effectiveness data are provided in the 84-Month Interim Post-Approval Study Status Report for New Enrollment PAS 2 – All Comers (dated November 19, 2020)
Actual Number of Patients Enrolled 375
Actual Number of Sites Enrolled 42
Patient Follow-up Rate 28%
Study Strengths & Weaknesses The SAE rates reported in PAS 3 are consistent with the risks associated with epilepsy itself, with treatment with antiepileptic medications, and with the literature-based historical risks associated with intracranial electrode implantation for epilepsy surgery evaluation and epilepsy surgery
combined, and with deep brain stimulation for movement disorder treatment. The SAE rates for the overall study and across onset zone subpopulations are similar to each other. The current number of subjects within each subpopulation is small; as such, the interim results should be
considered preliminary at this time.
The effectiveness data reported in PAS 3, while preliminary, support continued effectiveness in a real-world environment; during each 6-month period beginning from implant, overall the majority of patients reported a reduction in seizures of 65% or more.


New Enrollment -Performance & Programming Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/15/2014 05/08/2014 On Time
one year report 11/14/2014 11/10/2014 On Time
18 month report 05/15/2015 05/08/2015 On Time
two year report 11/14/2015 10/19/2015 On Time
three year report 11/13/2016 11/10/2016 On Time
four year report 03/13/2018 03/09/2018 On Time
five year report 12/31/2018 12/31/2018 On Time
six year report 11/13/2019 11/19/2019 Overdue/Received
seven year report 12/15/2020 11/25/2020 On Time
8 year report 12/15/2021 12/10/2021 On Time
9 year report 11/14/2022    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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