Objective
To evaluate the safety and performance of a novel carbon-fiber rigid system for sternal fixation.

Methods
This prospective, single-arm, single-center clinical investigation included 30 consecutive patients in whom sternotomy was closed using a carbon-fiber rigid sternal system. Patients were followed-up for 6 months post-operatively. The primary endpoint was sternal stability (SIS). Secondary endpoints included chest pain, device related complications and sternal healing using CT scan.

Results
Thirty patients (69.1±10.2 years old, 63.3% men) were included in the study. 53.3% of them presented two or more risk factors for sternotomy complications. Sternotomy closure took a mean of 15.9±3.8 minutes; implantation was assessed as easy or very easy in most cases (79.3%) and the surgeon was satisfied or very satisfied with the result of the sternotomy closure (96.6%). All patients patients presented stable sternum (SIS score 0) at 6 months follow-up all . Six months post-operatively, patients had adequate healing of the sternum (3.50±1.00) and were free of chest pain (0.04±0.20 NRS score). There were no complications related to the investigational device.

https://journals.sagepub.com/doi/10.1177/15569845241252393