Is sutureless coaptation the future of peripheral nerve repair ? Insights from an FDA - approved 3 D - printed device

Peripheral nerve injuries (PNIs) remain a significant clinical challenge due to the limited intrinsic regenerative capacity of peripheral nerves, procedure - related trauma, and the frequent development of neuropathic complications associated with convention al repair techniques such as microsuturing and autologous nerve grafting. These traditional approaches are often technically demanding, time - consuming, and may induce additional tissue damage at the repair site. In recent years, advances in three - dimension al (3D) printing technology have opened new avenues for peripheral nerve repair, particularly through the development of resorbable and minimally invasive biomaterials. This review focuses on the 3D - printed Coaptium Connect device developed by TISSIUM, which has received approval from the U.S. Food and Drug Administration for atraumatic, sutureless nerve repair. The device is based on a bioresorbable polymer system that f acilitates precise nerve coaptation without the need for sutures, thereby reducing surg ical complexity, operative time, and tissue trauma. While FDA approval confirms its safety and initial efficacy, further preclinical and long - term clinical studies, along with broader real - world use, are required to fully elucidate its limitations, durabil ity, and definitive role in the evolving landscape of peripheral nerve repair.