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ConforMIS Receives CE Mark Certification For iUni G2

ConforMIS, a privately-held company that develops and commercializes medical devices for osteoarthritis treatment and joint damage, has received CE mark certification for patient-specific unicompartmental knee resurfacing implant iUni G2 to sell throughout the European Union.

ConforMIS said that the enhancements to the iUni G2 include an advanced, patient-specific and wear optimized design, instrument changes for an even simpler surgical techniques, and iView patient-specific images for improved surgical planning.

The changes provide an array of advantages to patients, surgeons and hospitals. The iUni G2 offers patient-specific, anatomic fit for natural kinematics, full coverage of all weight bearing areas and a new implant designed for low contact stress and micro-motion. Patients benefit from a resurfacing solution with minimal bone resection, preservation of all ligaments, no intramedullary canal penetration, and the ability for a simple conversion to a primary total knee arthroplasty.

ConforMIS’ iUni G2 surgery uses iJig patient-specific instrumentation to reduce the number of surgical steps and to minimize intra-operative sizing and trials. In addition, the new iView patient-specific planning images introduce an entirely new and simple way to visualize joint preparation during surgery.

The iUni G2 provides an assortment of efficiency benefits to surgeons and hospitals, including simplified set-up and tear down, minimal instrumentation for the surgery, complete system delivery in a disposable kit and reduced sterilization and inventory costs.

Ronald Lederman and Mark Kwartowitz, orthopedic surgeons in West Bloomfield, said: “The iUni G2 is proof that ConforMIS values surgeon feedback. The result allows us to offer our patients a revolutionary implant that delivers the best of both worlds personalized implants for each patient with advanced engineering for a wear optimized design.

“This technology has changed the face of our practice. We now have more options for our younger patients, and have seen a 20-30% increase in patient volume from patients seeking personalized solutions.”