Conformis Receives CE Certification for iUni® G2 Patient-Specific Unicompartmental Knee Resurfacing Implant
iUni G2 Provides Superior Advantages to Patients, Surgeons, and Hospitals Including Minimal Bone Resection and Simplified Surgery
Burlington, Mass. – April 13, 2010
Conformis, Inc. announced today that the iUni® G2 has received CE Mark certification, providing regulatory approval for Conformis to begin the sale of this product throughout the European Union. The iUni G2 is the next generation of Conformis’ revolutionary patient-specific knee replacement system, and remains the only patient-specific unicompartmental knee resurfacing implant on the market.
Ronals S. Lederman, M.D., and Mark A. Kwawrtowitz, D.O., orthopedic surgeons in West Bloomfield, MI and two of the leading users of the Conformis system credit Conformis for collaborating with surgeons on the new design. “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.”
The iUni G2 Advantages:
Enhancements to the iUni G2 include an advanced, patient-specific and wear optimized design, instrument changes for an even simpler surgical technique, and iView™ patient-specific images for improved surgical planning. These changes provide an array of advantages to patients, surgeons and hospitals, including:
- Patient-specific fit and wear optimized design: 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.
- Minimally invasive and minimally traumatic procedure: 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.
- Simple and reproducible surgical technique: 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.
- Operating room efficiencies: 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.
- Conformis website: www.conformis.com
About Conformis, Inc.
Conformis, Inc. is a privately-held company that develops and commercializes medical devices for osteoarthritis treatment and joint damage. Its proprietary intellectual property includes more than 250 patents and patent applications in the areas of imaging software, image processing, implant design, surgical techniques, instrumentation, and manufacturing. Conformis knee implants and instrumentation are designed to address all stages of osteoarthritis, the most common reason for knee replacement surgery. All devices have been cleared by the US Food and Drug Administration for marketing in the US. In 2009, Conformis was named a winner of the Medical Design Excellence Awards, the premier recognition for contributions and advances in the design of medical products, for its iUni and iDuo resurfacing implants.
New Clinical Study Finds Bilateral Knee Patients Prefer Conformis’ Fully Personalized Solution Over Competitive Off-the-Shelf Implants by a Factor of Over 10 to 1
Study included only patients with a fully personalized Conformis implant in one knee after previously receiving a competitive off-the-shelf implant
Conformis iTotal® CR Knee Replacement System Awarded “7A” Performance Rating from the U.K.’s Orthopaedic Data Evaluation Panel
Independently verified assessment of the performance of the fully personalized iTotal CR system over a 7-year period confirms that it meets the panel’s demanding standards