f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • 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...


EMPROVE Extension Study

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Completed
Application Number /
Requirement Number
P180007 / PAS001
Date Original Protocol Accepted 03/01/2019
Date Current Protocol Accepted 09/01/2021
Study Name EMPROVE Extension Study
Device Name Spiration® Valve System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The study is designed as continued, prospective, long-term follow up of the EMPROVE pre-market cohorts. The objective is to evaluate the long-term safety and effectiveness of the Spiration Valve System for the treatment of severe emphysema. This will be an observational study for long-term follow-up of the EMPROVE Trial pre-market patient cohort with no planned interventions
Study Population All active (enrolled and not withdrawn) subjects continuing long-term (beyond 1 year) follow-up in protocol CPR-03434.
Key Study Endpoints Primary Safety:
All serious adverse events and non-serious adverse events related to the device or procedure will be assessed at annual follow-up visits by seriousness, severity, and relatedness.

Effectiveness Observations:
The following effectiveness assessments will be undertaken at annual follow-up visits:
St. George’s Respiratory Questionnaire (SGRQ)
COPD Assessment Test (CAT)
Modified Medical Research Council dyspnea scale (mMRC)
Quality of Well Being (QWB) questionnaire

Follow-up Visits and Length of Follow-up Control group subjects will be followed annually through 2 years.
Treatment group subjects will be followed annually through 5 years.
a1 antitrypsin deficiency subjects (a separate non-randomized treatment cohort) will be followed annually through 5 years.
Interim or Final Data Summary
Actual Number of Patients Enrolled 172
Actual Number of Sites Enrolled 31
Patient Follow-up Rate 99% for treatment arm at 5 years. 85% for control arm at 2 years.
Final Safety Findings Composite safety endpoint: Treatment group = 12.5% at 5 years; Control group = 20% at 2 years.
Final Effect Findings Primary endpoint = FEV1 improvement 0.098 liters at 6 months in comparison with the control group. At 2 years the FEV1: Improvement between Treatment and Control groups = 0.085 liters on average (95% BCI: 0.016 – 0.153), with a posterior probability of superiority > 0.9923. At 5 years the FEV1: Improvement is 0.049 liters (0.049 -/+ 0.247).
Study Strengths & Weaknesses The sponsor has conducted a randomized controlled multi-center trial with 5-year follow up for treatment arm, but only 2-year follow up for control arm, following the approved protocol. In addition, control subjects were not blinded and were immediately aware of their assignment to the control group upon randomization, and therefore suffered a 15% drop-out rate.
Recommendations for Labeling Changes There are no new or unexpected findings in or conclusions drawn from this Final Report which would suggest that a labeling update is necessary.

EMPROVE Extension Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 12/03/2019 02/25/2020 Overdue/Received
two year report 03/01/2021 02/25/2021 On Time
3 year report 03/01/2022 02/28/2022 On Time
final report 03/16/2023 03/16/2023 On Time
final report amendment 04/20/2023 04/20/2023 On Time

Contact Us

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

Additional Resources