• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

Lead Extraction Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Completed
Application Number P100026 / PAS004
Date Current Protocol Accepted 02/18/2014
Study Name Lead Extraction Study
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is an open-label prospective observational study of patients treated with the RNS System. Patients are from both continued follow-up of premarket cohorts and new enrollment.
Study Population Description All patients implanted with the RNS Neurostimulator and/or Lead(s), including patients in the LTT study and the RNS System PAS2 study, as well as non-study patients whose product data are monitoring systems that consent and have surgical procedures for explant/removal, reimplantation, or revision of the Neurostimulator and Lead(s).
Sample Size A minimum of 20 procedures to remove a Lead must be collected.
Data Collection The incidence and number of adverse events related to surgical

procedures associated with implant, explant/removal, reimplantation, and revision of the Neurostimulator and Lead(s)



Two groups of adverse events will be presented: (1) adverse events that lead to a surgical procedure, and (2) adverse events that occur as a consequence of a surgical procedure (i.e. complication). Within each of the 2 adverse event groups, the incidence and number of events will be presented for 3 categories:

¿ Serious adverse events

¿ Serious device-related adverse events

¿ Non-serious adverse

Follow-up Visits and Length of Follow-up N/A and N/A
Interim or Final Data Summary
Actual Number of Patients Enrolled The pool of subjects enrolled could originate from the other ongoing post-approval clinical studies as well as from commercial use; the number of subjects enrolled was not a reporting requirement for this PAS. During the time period studied, a total of 745 patients underwent 823 surgeries related to the RNS NeuroPace system and were eligible for PAS 4. For this lead extraction study, there were 54 attempts in 53 patients to extract a lead.
Actual Number of Sites Enrolled The pool of study sites could originate from the other ongoing post-approval clinical studies as well as from commercial use. The number of study sites enrolled was not a reporting requirement for this PAS 4.
Patient Follow-up Rate NA. Follow-up rate is only relevant to those PAS 4 participants who originated from PAS 1 and PAS 2, but not also commercial use participants. Follow-up was not part of this PAS reporting requirements.
Final Safety Findings There was a cumulative total of 104 adverse events (AEs) reported as occurring with an RNS System surgery for an incidence of 12.6% (104/823 surgeries). 76 of the 104 events (73%) were serious AEs for (SAE incidence of 76/823 or 9.2%). 56 of the 104 events (53.8%) (28/56 serious) were attributed directly to the RNS System surgery (a consequence of surgical procedure). 21 of the 104 events (20.2%) were not related to a prior RNS System surgery but led to a procedure involving the RNS System (all serious). 27 of the 104 events (26%) were both a consequence of a prior RNS System surgery and led to one or more subsequent RNS System surgeries (all serious). The frequency of AEs was comparable to the incidence of AEs reported in the PMA. Infection was the highest reported adverse event. Lead revision rate remained low. Reasons for explantation and analysis of devices returned revealed no concerns related to the device. There were no unexpected adverse events reported.
Final Effect Findings The study was designed to evaluate safety only.
Study Strengths & Weaknesses Adverse events related to the surgical procedures related to the implant, explant or revision of the RNS neurostimulator and leads were characterized in 823 surgeries from 745 eligible patients including long term treatment, new enrollment (all comers), and commercial use patients. The study also provided lead extraction data on 54 lead extraction attempts in 53 patients.



A study weakness is that the study only reported deaths if they were related to the device; this PAS was not designed to capture possible cofounders that could be contributing to cause of death.



Recommendations for Labeling Changes NONE


Lead Extraction Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/15/2014 05/13/2014 On Time
one year report 11/14/2014 11/13/2014 On Time
18 month report 05/15/2015 05/14/2015 On Time
two year report 11/14/2015 11/02/2015 On Time
three year report 11/13/2016 11/07/2016 On Time
Final Report 11/13/2017 10/23/2017 On Time


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

Related Links

-
-