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

Abstract

In this real-world experience Post-marketing Clinical Follow-up study conducted in accordance with EU MDR 2017/745 in 80 subjects from >65 surgical centers across various surgical specialties, ADVALENE (Polypropylene) monofilament, synthetic, non-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. ADVALENE (Polypropylene) sutures are a safe and effective option for a very wide variety of surgical procedures in a diverse population.