Adverse EventsHigher adverse event rates observed for ATEV in the analysis, with thrombosis being the largest area of difference in adverse events.
Product HandlingHandling issues by surgeons who are more familiar with stiff PTFE grafts compared to HUMA's softer device may have contributed to the thrombosis rate.
Regulatory ChallengesRisks include failure of clinical trials to prove efficacy, regulatory requirements for additional clinical studies, and failure of products to show sufficient competitive differentiation.