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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database
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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Ellipsys Vascular Access System PS Study


 
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General
Study Status Delayed
522 Number / Requirement Number PS200001 / PSS001
Date Original Plan Accepted 05/29/2020
Date Current Plan Accepted 12/29/2022
Study Name Ellipsys Vascular Access System PS Study
Device Name Ellipsys vascular access system
Root Document Number DEN170004 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Prospective, multi-center, single-arm, non-randomized, observational, post-market surveillance (PS) study.
The primary objective of this post-market surveillance study is to support the short-term safety of the device and procedure and further assess long-term safety and effectiveness in subjects treated by newly trained providers of the Ellipsys Vascular Access System in the creation of a native AV fistula via percutaneous access in subjects who are on hemodialysis and are medically indicated for the creation of an upper limb anastomosis.
Study Population patients who are on hemodialysis and are medically indicated for the creation of upper limb anastomosis.
Sample Size Up to 134, over 14 US sites
Key Study Endpoints Primary Safety Endpoint:
Early Occlusion, Study Related Serious Adverse Events through 12 months
Primary Effectiveness Endpoint:
Cumulative Patency through 12 months post-AVF creation
Follow-up Visits and Length of Follow-up 12 months
Interim or Final Data Summary
Interim Results No interim results have been reported to date.
Actual Number of Patients Enrolled 2
Actual Number of Sites Enrolled 4
Patient Followup Rate 100%
Study Strengths and Weaknesses This study is ongoing and the results are interim. Final analyses of endpoints will not be completed until the study
concludes.


Ellipsys Vascular Access System PS Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/29/2020 11/25/2020 On Time
1 year report 05/29/2021 05/25/2021 On Time
18 month report 11/29/2021 11/24/2021 On Time
2 year report 05/29/2022 05/31/2022 On Time
30 month report 05/29/2023 05/24/2023 On Time
3 year report 11/29/2023 11/16/2023 On Time
42 month report 05/29/2024    


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
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