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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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SVS Post-Market Registry Study


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General
Study Status Study Pending
Application Number P180007 / PAS002
Date Current Protocol Accepted  
Study Name SVS Post-Market Registry Study
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 the PAS registry study registry is to collect safety and effectiveness data in a post-approva1 setting for the Spiration Valve System (SVS). The SVS will be used as intended and in accordance with FDA-approved labeling.



This post-market study is a single-arm, prospective, multi­ center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States.

Study Population Description The population will be comprised of subjects with severe emphysema and evidence of low collateral ventilation, such as fissure integrity.
Sample Size 150 subjects at a minimum of 10 sites and up to 40 sites.
Data Collection Primary Safety:

Incidence of pre­ specified thoracic adverse events of special interest {TAEsSI) through 12 months following the first implantation procedure, including but not limited to acute asthma or bronchospasm; acute exacerbation of COPD, airway injury from valve placement, valve migration, or airway stenosis from a valve, hemoptysis, pneumonia, pneumothorax, and respiratory failure that requires mechanical intervention.



Secondary Safety:

(a) 45-day pneumothorax rate.



(b) Survival rate over 24 months compared to the EMPROVE study control cohort

Follow-up Visits and Length of Follow-up All enrolled Subjects who undergo the SVS procedure will be monitored for outcome data from baseline through 3 years post-first implant.


SVS Post-Market Registry Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/22/2020    
one year report 03/22/2021    
18 month report 09/22/2021    
two year report 03/22/2022    
three year report 03/22/2023    
four year report 03/22/2024    


Contact Us

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

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