Moirai Orthopaedics, a US-based orthopaedic implant development company, has received CE mark approval for its new Pyrocarbon Implant Replacement (PIR) system, which is designed to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee.
The PIR system is a one-piece implant, developed in collaboration with the not-for-profit Fellowship of Orthopaedic Researchers.
The implant is fabricated with hydroxyapatite coating on all bone interfacing surfaces using On-X Life Technologies’ On-X pyrolytic carbon.
The pyrolytic carbon material’s wear properties help in extending the functional life of the implant.
According to the company, the PIR System will be particularly useful for patients too young to undergo a total knee replacement; either poor candidates for, or have failed cartilage regenerative procedures, and those unable to devote the rehabilitation time necessary for these procedures.
The company is currently planning to launch the implant in the fourth quarter of 2013, with initial implantations in Australia and England.
In addition to this, the company is also pursuing clearance of its IDE application through the FDA, and plans to begin a clinical trial in the US in the near future.
Moirai director of business development Samantha L Salkeld indicated that the company has had preliminary discussions with interested parties regarding acquisition of the PIR technology, and would consider this, should an appropriate opportunity arise.
The PIR system is implanted through a minimally invasive surgical approach, which articulates with the native tibia cartilage.
Unlike traditional knee replacement procedures, the tissue sparing PIR system retains healthy tissue during the surgery as it replaces only the damaged cartilage.
Fellowship of Orthopaedic Researchers chief scientist Dr Stephen D Cook said: "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 utilised in competitive products."
According to GlobalData estimates, the knee reconstruction market in Europe, which was valued at $1.56bn in 2012 and is expected to grow at a CAGR of 4.1% to reach a value of $2.08bn by 2019.