Virginia Commonwealth University Reports Findings in Arteriovenous Fistula [What Is the Maude Database Telling Us About 510(K) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices].

A report from Virginia Commonwealth University discusses research findings on arteriovenous fistula, a cardiovascular condition. The report focuses on the comparison between two generations of endovascular arteriovenous fistula devices, specifically the WavelinQ EndoAVF System and the WavelinQ 4F EndoAVF System. The research analyzes adverse events reported for both devices and identifies changes in patient and device outcomes. The study emphasizes the importance of the FDA Manufacturer and User Facility Device Experience reporting in ensuring device safety during the marketing approval process. [Extracted from the article]