The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for US-based implant development firm Moirai Orthopaedics to begin the clinical trial of its Pyrocarbon Implant Replacement (PIR) system.
Developed in collaboration with US-based Fellowship of Orthopaedic Researchers, the PIR System secured CE Mark in August 2013.
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The patented PIR System is a single-component implant fabricated from On-X pyrolytic carbon, with hydroxyapatite coating on all bone interfacing surfaces.
The company plans to start the clinical trial of the system this summer, with the first implantations carried out by New Orleans’s Ochsner Sports Medicine Institute section head of Sports Medicine 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 trial is designed 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.
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By GlobalDataThe company said the targeted indication is for treatment of symptomatic cartilage defects of the anterior or central medial femoral condyle in patients who had an inadequate response to prior conservative treatment or previous arthroscopic debridement and lavage.
The system is designed 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.
Currently, the PIR knee system is limited to investigational use in the US.
The company said the investigational PIR implant is placed as a hemi-arthroplasty through a minimally invasive surgical approach and articulates with the native tibia cartilage.
