Conformis iTotal CR Knee Replacement System Awarded ‘5A’ Rating

Conformis Inc., a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture, and sell patient-specific knee and hip joint replacement implants designed to fit each patient’s unique anatomy, announced that the Orthopaedic Data Evaluation Panel in the United Kingdom (ODEP) awarded the Conformis iTotal CR knee replacement system a “5A” rating. The 5A rating is based on strong evidence of implant performance over five years, including low revision rates as indicated in the United Kingdom’s National Joint Registry (NJR).  
 
ODEP is an independent panel of leading orthopedic surgeons and experts in the UK that 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 (NHS) with an approved list of products that meet the revision rate standard set by the National Institute for Health and Care Excellence (NICE) in the UK. The 5A rating is based on five-year performance data. ODEP ratings provide a simple, independently verified assessment as to the performance of an implant, assessed against national clinical best practice guidelines. This enables clinicians to ensure that the implants that they use comply with these national guidelines. Only products that demonstrate compliance with NICE guidance are awarded a rating. To date, more than 65 surgeons in the United Kingdom have implanted over 1,000 iTotal CR implants with a five-year cumulative revision rate of 1.8 percent versus 2.2 percent for all other total knee replacements in the NJR.
 
“I am delighted that ODEP recognise what myself and other Conformis users know already. The rating, I hope, will help reassure patients and surgeons in their decision making process for knee arthroplasty,” said Stuart Roy of Spire Cardiff Hospital and Royal Glamorgan Hospital in Wales.
 
“The news that the Conformis iTotal-CR knee prosthesis has now been awarded an ODEP 5A rating comes as no surprise to me. Since I first started using Conformis knees back in 2012, I have seen a very significant improvement in outcomes for my knee replacement patients, with happier patients having better knee movement and significantly better function. Patient conforming knees are, in my opinion, by far the best type of knee replacement on the market, by a mile and pretty much every knee replacement I do now is patient conforming,” said Ian McDermott of London Bridge Hospital.
 
“We are pleased to have received the ODEP 5A rating,” said Mark Augusti, CEO and president of Conformis. “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 5A rating will provide more confidence to physicians that are considering offering our unique technology to their patients. In addition, we believe our results should provide an opportunity for Conformis to expand availability of our product at NHS facilities in the United Kingdom.”