Moirai Ortho‘s PIR System Nails CE Mark

Moirai Orthopaedics, L.L.C. is an orthopedic implant development company in Metairie, Louisiana, that received CE approval mark for its Pyrocarbon Implant Replacement (PIR) system. The PIR System is designed to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee. Company officials explain that their PIR System targets patients too young for a total knee replacement and patients who are poor candidates for or have failed cartilage regenerative procedures.

Officials describe the PIR System as being a one-piece implant, fabricated from On-X pyrolytic carbon with hydroxyapatite coating on all bone interfacing surfaces. The implant is placed as a hemi-arthroplasty, through a minimally invasive surgical approach, and articulates with the native tibia cartilage. Officials maintain that the wear properties of the system’s pyrolytic carbon material can extend the functional life of the implant. They say 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, ” said 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 the cobalt chromium alloy material utilized in competitive products, ” Cook added.

Moirai Orthopaedics reports that it expects to launch the product in the fourth quarter of 2013, with initial implantations in Australia and England. The company is currently pursing IDE (investigational device exemption) approval from the FDA and expects to initiate a clinical trial of the PIR System in the United States soon.