Metairie, LA – April 5, 2015 – Moirai Orthopaedics, LLC, an orthopaedic implant development company based in Metairie, Louisiana, is pleased to announce it has received approval from the US Food and Drug Administration (FDA) for its Investigational Device Exemption (IDE) application to initiate clinical study of the company’s multi-patented Pyrocarbon Implant Replacement (PIR) System. The PIR System was developed in conjunction with the Fellowship of Orthopaedic Researchers.
The purpose of the clinical study is to evaluate the safety and effectiveness of the PIR System in the treatment of articular cartilage defects (Outerbridge Grade III or IV) of the medial femoral condyle compared to control treatment. The targeted indication is for the treatment of symptomatic cartilage defects of the anterior or central medial femoral condyle in patients who have had an inadequate response to prior conservative treatment or previous arthroscopic debridement and lavage.
Over four million knee arthroscopies are performed annually worldwide, with approximately 60% demonstrating the presence of focal cartilage defects located primarily on the medial femoral condyle. The PIR System is designed for patients too young for a total knee replacement (TKR) who are either poor candidates for or those unable or unwilling to devote the necessary rehabilitation time for cartilage regenerative procedures.