Orthopaedic implant development firm Moirai Orthopaedics has obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence the clinical study of its Pyrocarbon Implant Replacement (PIR) system.
Developed in collaboration with Louisiana-based Fellowship of Orthopaedic Researchers, the PIR System obtained CE mark approval in August 2013. Currently, the system is limited to investigational use in the US.
The approval has been granted to assess 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.
According to the company, 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.
Moirai intends to commence the clinical trial of the system in the summer of this year, with the first implantations carried out by New Orleans’s Ochsner Sports Medicine Institute Sports Medicine section head Dr Deryk Jones.
Dr Jones said: "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 company developed the PIR system for younger patients who are in need of total knee replacement (TKR) or either poor candidates for or those unable or unwilling to devote the necessary rehabilitation time for cartilage regenerative procedures.
The patented PIR System is a single-component implant fabricated from On-X pyrolytic carbon, with hydroxyapatite coating on all bone interfacing surfaces.
The investigational PIR implant will be placed as a hemi-arthroplasty through a minimally invasive surgical approach and articulates with the native tibia cartilage.
Image: A synovial joint with bone, articular cartilage, and articular disc. Photo: courtesy of Henry Vandyke Carter.