Active Implants Corporation (AIC), a developer of less invasive orthopedic implants created using pliable structured material and innovative design, has received CE mark approval for its class III TriboFit Hip System.
The TriboFit Hip System employs the only pliable, medical grade polycarbonate-urethane (PCU) acetabular implant available.
“The achievement of the CE Class III designation and the clinical experience of the TriboFit acetabular Buffer represent an important step in validating the use of polycarbonate-urethane as a new bearing material in human hip joint reconstruction,” said Richard Treharne, PhD., Vice-President, Orthopaedic Research. Dr. Treharne further added: “We believe the TriboFit Hip System offers clinicians a new bearing surface alternative with the benefits of existing systems and without the limitations associated other current bearing systems.”
TriboFit uses a new, low wear PCU material that is hydrophilic, promoting the lubrication of articulating surfaces. PCU has characteristics similar to human cartilage. It is a pliable and durable material.
The TriboFit Hip System consists of acetabular components that are used for hip joint reconstruction. The TriboFit Hip System Buffer implant offers a less invasive acetabular component that is bone conserving and allows a larger anatomical femoral head size to optimize joint stability and range of motion.
TriboFit originally received a CE Mark Class IIb and is being commercialized in select European markets. AIC has launched a post approval collaborative market study in Europe with leading orthopaedic surgeons. Enrollment in a multi-center, prospective study continues to evaluate the long term benefits of the TriboFit system. The human clinical experience includes almost 500 patients over the past three years. A combination of prospective and retrospective study data is being evaluated on the clinical performance of the TriboFit Hip System.