The goal of this study is to assess the safety and efficacy of Symvess in sexually mature adolescents (17 years of age or younger) who require a vascular conduit to repair an extremity arterial injury when autologous vein graft is not available.
The main questions the study aims to answer are:
Safety and tolerability of Symvess in adolescent patients? Determine patency of Symvess over 12-months Evaluate the long-term amputation-free rate Determine the ability of Symvess to remain infection-free
Participants will undergo implantation of Symvess to repair an arterial injury in an extremity using standard surgical techniques. Following implantation, patients will be followed for up to 12-months where they will undergo standard safety assessments, patency assessments using Duplex Ultrasound, and examination of the surgical site.