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.

Learn more...

ZEVR-Zephyr Valve Registry

General
Study Status	Ongoing
Application Number / Requirement Number	P180002 / PAS002
Date Original Protocol Accepted	05/03/2019
Date Current Protocol Accepted	03/25/2023
Study Name	ZEVR-Zephyr Valve Registry
Device Name	Zephyr Endobronchial Valve System
Clinical Trial Number(s)	NCT00129584 NCT01580215 NCT01796392 NCT02022683 NCT02025205
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	Prospective Cohort Study: Multi-center, single-arm, prospective Registry to be conducted at up to 15 clinical sites. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure. The Zephyr Valve Registry will be conducted at a minimum of 5, and a maximum of 10 clinical sites. Enrollment is anticipated to be completed over 24 months. A minimum of 20 subjects treated with at least one Zephyr 5.5-LP EBV will be enrolled.
Study Population	Adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. Concurrent control comparison group.
Sample Size	150
Key Study Endpoints	Safety endpoints: Incidence rate of Pneumothorax at 45-days post-procedure. Incidence rate of device/procedure related Serious Adverse Events (SAE) including but not limited to COPD exacerbations, pneumonia, hemoptysis, valve expectoration, valve migration and respiratory failure. Effectiveness endpoints: Treated Lobar Volume Reduction (TLVR) assessed by HRCT at 45-days. Forced Expiratory Volume in 1 second (FEV1) at 6-months, 12-months, 24-months and 36-months. 6MWD at 6-months and 12-months. SGRQ at 6-months and 12-months. BODE Index at 6-months and 12-months. Percent of patients with a TLVR of =350mL10,11. Percent of patients with a TLVR of =563mL12. Responder rates reported as percent of patients meeting the Minimal Clinically Important Difference (MCID) for each variable at 6-months and 12-months. - MCID for FEV1: Increase of 10% (Liters) - MCID for 6MWD: Increase of +25 meters - MCID for SGRQ: Decrease of 4 points
Follow-up Visits and Length of Follow-up	36 months

ZEVR-Zephyr Valve Registry Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	12/28/2018	01/07/2019	Overdue/Received
1 year report	06/29/2019	06/13/2019	On Time
18 month report	12/28/2019	12/18/2019	On Time
2 year report	06/28/2020	06/25/2020	On Time
3 year report	06/28/2021	06/28/2021	On Time
4 year report	06/28/2022	06/28/2022	On Time
5 year report	06/28/2023	06/22/2023	On Time
6 year report	06/28/2024	06/26/2024	On Time
7 year report	06/28/2025

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

---

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