Active Implants Announces CE Class III Medical Device Approval.MEMPHIS Memphis, city, ancient Egypt Memphis (mĕm`fĭs), ancient city of Egypt, capital of the Old Kingdom (c.3100–c.2258 B.C.), at the apex of the Nile delta and 12 mi (18 km) from Cairo. , Tenn. -- Active Implants Corporation (AIC AIC Association des Infermières Canadiennes. ) today announced that it has received a CE Class III Certificate for its TriboFit[R] Hip System. The TriboFit[R] Hip System employs the only pliable, medical grade polycarbonate-urethane (PCU PCU - PCI Configuration Utility ) acetabular acetabular /ac·e·tab·u·lar/ (as?e-tab´u-lar) pertaining to the acetabulum. acetabular pertaining to the acetabulum. acetabular dysplasia see hip dysplasia. 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[R] 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[R] uses a new, low wear PCU material that is hydrophilic hydrophilic /hy·dro·phil·ic/ (-fil´ik) readily absorbing moisture; hygroscopic; having strongly polar groups that readily interact with water. hy·dro·phil·ic adj. , promoting the lubrication lubrication, introduction of a substance between the contact surfaces of moving parts to reduce friction and to dissipate heat. A lubricant may be oil, grease, graphite, or any substance—gas, liquid, semisolid, or solid—that permits free action of of articulating surfaces. PCU has characteristics similar to human cartilage - it is a pliable and durable material. The TriboFit[R] Hip System consists of acetabular components that are used for hip joint reconstruction. The TriboFit[R] Hip System Buffer[TM] implant offers a less invasive acetabular component that is bone conserving and allows a larger anatomical femoral femoral /fem·o·ral/ (fem´or-al) pertaining to the femur or to the thigh. fem·o·ral adj. Of or relating to the femur or thigh. head size to optimize joint stability and range of motion. TriboFit[R] 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[R] 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[R] Hip System. About Active Implants Corporation Active Implants Corporation is a privately-held company formed in 2004 to develop and commercialize a new platform technology to treat articulating joints. The initial product on the technology platform is the TriboFit[R] Hip System. The next product under development is the NUsurface[R] Knee System, a device intended to treat pain in the meniscal deficient knee. A NUsurface[R] human pilot study is underway in Europe. |
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