ConforMIS, Inc., a medical technology company located in Billeric, Massachusetts, has been awarded a “3A” rating for its Total CR Knee replacement system.
ConforMIS Awarded “3A” Rating in the UK
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The rating was given by the Orthopaedic Data Evaluation Panel (ODEP) in the United Kingdom reflecting on “strong evidence of implant performance over three years, including low revision rates as indicated in the United Kingdom’s National Joint Registry.”
“The positive ODEP 3A rating reaffirms my experience treating patients with the ConforMIS iTotal CR knee replacement system, which I believe offers my patients a more natural feeling knee with improved performance and mobility,” said Ian McDermott, FRCS, senior consultant knee surgeon at London Sports Orthopaedics, based at the London Bridge Hospital in London.
“The clinical evidence and three-year survivorship data together are consistent with the improvement I am seeing with my patients’ outcomes after knee replacement surgery using ConforMIS knee prostheses.”
“ODEP ratings provide a reliable, simple and independent assessment of the performance of an implant” said, Fahad G. Attar, MBChB, FRCS, Consultant Trauma & Orthopaedic Surgeon at BMI Alexandra and Whiston Hospital, St. Helens & Knowsley Teaching Hospitals, United Kingdom.
“I expect that this 3A rating will now provide additional reassurance and peace of mind to my patients and reinforce the performance reputation of ConforMIS iTotal CR knee replacement implants that contribute to the improved clinical outcomes I am seeing in my practice.”
Mark Augusti, company president and CEO said, “This rating provides another independent verification that our design philosophy, predicated on patient conforming implants, results in performance where it counts the most, in patients. We hope that this 3A rating also provides an opportunity for ConforMIS to expand its product offering to more patients receiving their healthcare in NHS [National Health Services] facilities.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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