US-based Moirai Orthopaedics has obtained CE Mark approval for its new Pyrocarbon Implant Replacement (PIR) system, designed to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee.
The PIR system, which replaces the damaged cartilage and retains healthy tissue, has been developed in association with the not-for-profit Fellowship of Researchers.
Currently, Moirai Orthopaedics is pursuing the US Food and Drug Administration approval of its IDE application and expects to start a clinical trial in the US in the near future.
The PIR system that is fabricated from On-X Life Technologies’ On-X pyrolytic carbon with hydroxyapatite coating on all bone interfacing surfaces is expected to be launched in the fourth quarter of 2013, with initial implantations in Australia and England.
Fellowship of Orthopaedic Researchers chief scientist Dr Stephen D Cook noted pyrocarbon is the ideal biomaterial for this clinical application.
"In addition to its exceptional mechanical characteristics, including stiffness similar to bone, it has superior wear properties when articulating with native cartilage compared to the cobalt chromium alloy material utilized in competitive products," Dr Cook added.
Moirai Orthopaedics director of business development Samantha L. Salkeld noted the company is in discussions with interested parties regarding acquisition of the PIR technology.