Active Implants Announces CE Class III Medical Device Approval

Main Category: Medical Devices / Diagnostics
Article Date: 02 Sep 2009 - 7:00 PDT

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Active Implants Corporation (AIC) today announced that it has received a CE Class III Certificate for its TriboFit® Hip System.

The TriboFit® Hip System employs the only pliable, medical grade polycarbonate-urethane (PCU) acetabular implant available today.

"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.

Source
Active Implants Corporation

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