Moirai Orthopaedics, L.L.C., a Metairie, Louisiana based orthopaedic implant development company, is pleased to announce it has received CE mark approval for its new Pyrocarbon Implant Replacement (PIR) System. The PIR System, developed in conjunction with the not-for-profit Fellowship of Orthopaedic Researchers, is intended to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee. Over two million knee arthroscopies are performed annually worldwide, with 60% demonstrating the presence of focal cartilage defects. The PIR System targets patients too young for a total knee replacement; but either poor candidates for, or have failed cartilage regenerative procedures, as well as those unable to devote the rehabilitation time necessary for these procedures.
Moirai Orthopaedics expects to launch the product in the fourth quarter of 2013, with initial implantations in Australia and England. The company is currently pursuing clearance of its IDE application through the FDA, and expects to initiate a clinical trial of the PIR System in the United States in the near term. This early interventional cartilage replacement device will compete in both the $4 billion arthroscopy market and the $7 billion TKR market. Samantha L. Salkeld, M.S., Director of Business Development at Moirai, 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 a one-piece implant, fabricated from On-X pyrolytic carbon (On-X Life Technologies, Inc., Austin, Texas), 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. The unique wear properties of the System's pyrolytic carbon material can extend the functional life of the implant, making it appealing to both surgeons and patients. And, 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," stated 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," Dr. Cook added.