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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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WavelinQ EndoAVF


 
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General
Study Status Delayed
522 Number / Requirement Number PS180002 / PSS001
Date Original Plan Accepted 11/06/2020
Study Name WavelinQ EndoAVF
Device Name Wavelinq endoavf system
Root Document Number DEN160006 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective, multi-center, non-randomized, single- arm, post-market study for endoAVF creation in United States (U.S.) patients who require vascular access for hemodialysis. Follow-up for all treated subjects will be performed at discharge, 2-weeks, 6-weeks, 3-, 6-, 12-, 18- and 24- months post index procedure.
Study Population The study will enroll subjects who are either already receiving dialysis at the time of screening, regardless of access type (Central Venous Catheter (CVC), AV Fistula (AVF), AV Graft (AVG)), or are anticipated to need hemodialysis access for dialysis initiation in the near future. In addition, the study will make all reasonable efforts to treat a population that consists of at least 30% African Americans and have no single study site constitute more than 15% of the total study population.
Sample Size No. of subjects: 280
A maximum of 60 of the total treated population can be pre-dialysis at the time of index procedure. All subjects will be followed for 24 months post index-procedure.
No. of sites: 40
Site’s location: US
Key Study Endpoints Two primary effectiveness endpoints will be evaluated independently: the percentage of subjects with functional cannulation success through 6-months and primary patency through 6-months.

The primary safety endpoint is freedom from device-related or procedure-related serious adverse events (SAE) through 30 days.
Secondary Endpoints will include the following: Procedure Success
Cannulation Success Primary Patency Assisted Primary Patency Secondary Patency Functional Patency Functional Cannulation
Physical and Physiological Maturation CVC Exposure/Use
Procedural Adjunctive Procedures Post Procedural Secondary Procedures

Training Effectiveness Serious Adverse Events Adverse Events
Unanticipated (Serious Adverse) Device Events
Follow-up Visits and Length of Follow-up Subjects will be followed up through 24 months.
Follow-up for all treated subjects will be performed at
discharge, 2-weeks, 6-weeks, 3-, 6-, 12-, 18- and 24-months post index procedure.
Interim or Final Data Summary
Actual Number of Patients Enrolled 17
Actual Number of Sites Enrolled 4
Patient Followup Rate N/A
Final Safety Findings N/A
Final Effectiveness Findings N/A


WavelinQ EndoAVF Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 05/07/2021 05/10/2021 Overdue/Received
1 year report 11/06/2021 11/08/2021 Overdue/Received
18 month report 06/06/2022 06/07/2022 Overdue/Received
2 year report 11/06/2022 11/07/2022 On Time
30 month report 05/05/2023 05/05/2023 On Time
3 year report 11/06/2023 11/06/2023 On Time
42 month report 05/06/2024    
4 year report 11/06/2024    


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