The Food and Drug Administration has granted an Investigational Device Exemption (IDE) to Moirai Orthopaedics L.L.C. of Metairie, Louisiana, for its Pyrocarbon Implant Replacement System (PIR).
The PIR System is a single-component implant, fabricated from On-X pyrolytic carbon with hydroxyapatite coating on all bone interfacing surfaces. As the company explains, the investigational PIR implant is placed as a hemi-arthroplasty through a minimally invasive surgical approach and articulates with the native tibia cartilage. The wear properties of the PIR System’s pyrolytic carbon material are expected to extend the functional life of the implant. Company officials claim that, 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.”
The purpose of the clinical study is to evaluate the safety and effectiveness of the PIR System in the treatment of articular cartilage defects. 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, say company officials, is designed for patients too young for a total knee replacement.
Moirai Orthopaedics expects to begin its clinical trial of the PIR System in the summer of 2015, with the first implantations performed by Deryk G. Jones, M.D., Section Head of Sports Medicine at the Ochsner Sports Medicine Institute in New Orleans. 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 use of the PIR System is presently limited to investigational use only in the United States.
