Post-Approval Studies (PAS) Database

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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EPAS using RWD from the MORE Registry

General
Study Status	Study Pending
Application Number / Requirement Number	P960009 S219/ PAS002
Date Original Protocol Accepted	12/17/2025
Date Current Protocol Accepted	12/17/2025
Study Name	EPAS using RWD from the MORE Registry
Device Name	MEDTRONIC DBS THERAPY FOR EPILEPSY
Clinical Trial Number(s)	NCT00101933
General Study Protocol Parameters
Study Design	Other Study Design
Data Source	Other Data Source
Comparison Group	Objective Performance Criterion
Analysis Type	Analytical
Study Population	Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	Subjects will be selected from the MORE registry using the previously approved Epilepsy Post-Approval Study (EPAS) study inclusion and exclusion criteria, creating an ‘EPAS-like’ subgroup (EPAS-Like Cohort Criteria). Primary Effectiveness Objective - To evaluate the changes in total seizure frequency at 3 years Secondary Effectiveness Objectives - To evaluate the reduction in total seizure frequency assessed during the baseline phase to 12 months of DBS - To evaluate the reduction in disabling seizure frequency assessed during the baseline phase to 12 months of DBS - To evaluate the reduction in frequency of seizures originating in the temporal lobe assessed during the baseline phase to 12 months of DBS Secondary Safety Objective - To characterize the SUDEP rate
Study Population	The intended study population is subjects 18 years and older diagnosed with epilepsy characterized by focal-onset seizures that are refractory to at least 3 AEDs
Sample Size	There are 90 subjects that met the criteria.
Key Study Endpoints	Safety Endpoints Primary Effectiveness: To demonstrate that the total seizure frequency during is reduced by 40% after 3 years. Secondary: Secondary Effectiveness Objectives: 1. To demonstrate that the total seizure frequency assessed during the phase is reduced after 12 months 2. To demonstrate that the disabling seizure frequency assessed during the is reduced after 12 months 3. To demonstrate that the frequency of seizures originating in the temporal lobe assessed during the phase is reduced after 12 months Secondary Safety Objective: 4. To characterize the Sudden Unexpected Death in Epilepsy (SUDEP) rate
Follow-up Visits and Length of Follow-up	3 years

EPAS using RWD from the MORE Registry Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
final report	12/17/2026	03/06/2026	On Time

Contact Us

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

Additional Resources

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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background