• 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...


             

ZEVR-Zephyr Valve Registry


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P180002 / PAS002
Date Current Protocol Accepted  
Study Name ZEVR-Zephyr Valve Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of

adult patient with hyperinflation associated with severe emphysema in regions of the lung that have little to no

collateral ventilation. This is a multi-center, single-arm, prospective post-approval study.
Study Population Description This is an all-comers registry. The population will be comprised of subjects with hyperinflation of the lungs due to severe

emphysema that are considered appropriate for the procedure by their treating physician and confirmed to have little to no

collateral ventilation.
Sample Size 150 subjects from 5 to 10 centers
Data Collection Safety Endpoints:

1. 45-day pneumothorax rate

2. Device and Procedure related SAEs (including but not limited to COPD exacerbations with hospitalization, pneumonia,

hemoptysis, valve expectoration, respiratory failure) out to 36-months.

Effectiveness Endpoints:

1. Treated Lobar Volume Reduction (TLVR) at 45-Days

2. Forced Expiratory Volume in 1 second (FEV1) at 6-months 12-months, 24- months, and 36-months

3. 6-Minute Walk Distance (6MWD) at 6-months and 12-months

4. St. George’s Respiratory Questionnaire (SGRQ) at 6-months and 12-months (if available)

5. BODE Index at 6-months and 12-months
Follow-up Visits and Length of Follow-up 3 years post-implant


ZEVR-Zephyr Valve Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/28/2018 01/07/2019 Overdue/Received
one year report 06/29/2019 06/13/2019 On Time
18 month report 12/28/2019    
two year report 06/28/2020    
three year report 06/28/2021    
four year report 06/28/2022    


Contact Us

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

Related Links

-
-