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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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EverlinQ endoAVF


 
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General
Study Status Study Pending
522 Number / Requirement Number PS180002 / PSS001
Date Current Plan Accepted  
Study Name EverlinQ endoAVF
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 Design Description The objectives of the study are a) to evaluate physician training effectiveness through observed adverse event rates, and b) to assess long-term safety and effectiveness of the WavelinQ EndoAVF System in creating endoAVF in a representative population of indicated patients in the U.S.



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.

Study Population Description 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 A total of approximately two hundred eighty (280) subjects will be treated in the study. A maximum of 60 of the total treated population can be pre-dialysis at the time of index procedure.



The sample size was determined in order to provide sufficient subjects evaluable for both primary effectiveness endpoints, which will be assessed at 6-months post- procedure. The alpha for both primary effectiveness endpoints is a two-sided 0.025. The estimated power accounting for attrition (estimated to be 20% at 6-months), and 176 subjects evaluable at 6-months, is 90% given the estimated actual performance and the performance goal for each (see hypothesis summary).

The primary safety endpoint will be estimated at 30-days post-procedure, an assumption of 20% attrition through 30- days will still be used, the alpha will be a two sided 0.05, and 224 evaluable subjects will result in a power of 99% given the estimated actual performance and the performance goal (see hypothesis summary).
Data Collection 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.



EverlinQ endoAVF Schedule

Report 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    
2 year report 11/06/2022    
4 year report 11/05/2023    


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