Moirai Orthopaedics, L.L.C., 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 Pyrocarbon Implant Replacement (PIR) System. The PIR System previously received CE mark approval in August 2013.
The PIR System was developed in conjunction with the Fellowship of Orthopaedic Researchers (Metairie, LA).
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. The use of the PIR System is limited to investigational use in the United States.
Moirai Orthopaedics expects to begin a clinical trial of the PIR System in the summer of 2015, with the first implantations performed by Dr. Deryk G. Jones, Section Head of Sports Medicine at the Ochsner Sports Medicine Institute in New Orleans. Dr. Jones commented: "The PIR System has the potential to address an important unmet clinical need and we have been anxiously awaiting the start of the study." The early interventional cartilage replacement PIR system is expected to compete in both the $4 billion arthroscopy market and the $7 billion TKR market. Samantha L. Salkeld, M.S., Director of Business Development at Moirai, indicated that the company has the ability to fund the clinical study on its own but is also currently in discussions with parties regarding acquisition of the PIR technology.
The patented PIR System is a single-component implant, fabricated from On-X pyrolytic carbon (On-X Life Technologies, Inc., Austin, Texas), with hydroxyapatite coating on all bone interfacing surfaces. The investigational PIR implant is placed as a hemi-arthroplasty through a minimally invasive surgical approach and articulates with the native tibia cartilage. The unique wear properties of the PIR System's pyrolytic carbon material are expected to extend the functional life of the implant, making it appealing to both surgeons and patients. In addition, unlike conventional knee replacement procedures, the tissue-sparing PIR System replaces only the damaged cartilage, while retaining healthy tissue.
"Pyrocarbon is the ideal biomaterial for this clinical application," stated Stephen D. Cook, Ph.D., Chief Scientist at the Fellowship of Orthopaedic Researchers. "In addition to its exceptional mechanical characteristics, including stiffness similar to bone, it has superior wear properties when articulating with native cartilage compared to other orthopaedic biomaterials in preclinical studies."
Moirai Orthopaedics, L.L.C.