The Orthopaedic Data Evaluation Panel in the United Kingdom awarded the ConforMIS iTotal CR knee replacement system a "3A" rating.
Here are four things to know.
1. The rating is based on strong implant performance evidence over three years, including low revision rates as indicated in the U.K.'s National Joint Registry.
2. ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology to develop, manufacture and sell joint replacement implants that are designed and manufactured to fit to the patient's unique anatomy.
3. ODEP is an independent panel of leading U.K. orthopedic surgeons and experts. The panel evaluates data related to use of hip and knee implant technologies and provides a rating to indicate performance in key areas including survivorship. ODEP provides the National Health Service with an approved list of products that meet the revision rate standard set by the National Institute for Health and Care Excellence in the U.K.
4. ODEP ratings provide an independently verified assessment of implant performance, evaluated assessed against national clinical best practice guidelines. This enables clinicians to ensure that the implants they use comply with these national guidelines. Only products that demonstrate NICE guideline compliance are awarded a rating.
Here is more information on the rating system.
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