A Retrospective, Multicenter, Observational Real World Post Market Clinical Follow Up Study to Evaluate Acute Safety and Device Procedural Success of ADVAPD (Polydioxanone) Surgical Suture. (ADVAPD PMCF Study)

Abstract

In this real-world experience Post-marketing Clinical Follow-up study conducted in accordance with EU MDR 2017/745 in 70 subjects from >55 surgical centers across various surgical specialties, ADVAPD (Polydioxanone) monofilament, synthetic absorbable sterile surgical sutures demonstrated excellent suture, needle, and overall performance. No wound complications or adverse events were reported in this study during the follow-up period of 3 months, and there were no reports of prolonged or repeat hospitalization. ADVAPD (Polydioxanone) sutures are a safe and effective option for a very wide variety of surgical procedures in a diverse population.