Moirai Orthopaedics Receives Approval for Implant System
Moirai Orthopaedics LLC, a Metairie, La.-based orthopedic implant development company, has received CE mark approval for its new Pyrocarbon Implant Replacement (PIR) System.
The PIR system, which replaces the damaged cartilage and retains healthy tissue, is designed to treat patients with focal chondral and osteochondral defects of the medial femoral condyle of the knee. The device has been developed in association with the not-for-profit Fellowship of Researchers.
Focal cartilage defects are responsible for roughly 60 percent of the more than 2 million knee arthroscopies performed annually. The PIR System targets patients too young for a total knee replacement but either are poor candidates for, or have failed cartilage regenerative procedures, as well as those that don't have the time to rehabilitate the joint.
Moirai Orthopaedics expects to launch the product in the next three months, with initial implantations in Australia and England. The company has applied for U.S. Food and Drug Administration approval through the Investigational Device Exemption route and expects to begin U.S. clinical trials soon.
The early interventional cartilage replacement device will compete in both the $4 billion arthroscopy market and the $7 billion TKR market.
The PIR System is a one-piece implant made 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," 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."
Moirai Orthopaedics is a privately held orthopedic device developer.