Conformis, an orthopaedic medical device company that features personalised knee and hip replacement products, has received a “7A” rating by the Orthopaedic Data Evaluation Panel in the United Kingdom (ODEP) for the Conformis iTotal CR knee replacement system.
The 7A rating (denoting the assessment of seven years of performance data) supersedes Conformis’ previous 5A (five-year period) rating and demonstrates continued strong evidence of successful implant performance. In particular, the iTotal CR knee replacement system has shown low rates of revision (removal and replacement of at least part of the original implant), as indicated in the U.K.’s National Joint Registry (NJR). In addition, the company’s iTotal CR knee with iPoly XE insert has received a 5A rating from the respected quality benchmarking agency.
ODEP is an independent panel of leading orthopaedic surgeons and experts in the United Kingdom that evaluates data from hip, knee, and other joint implants generating a rating that measures performance in key areas including survivorship. ODEP provides the 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 U.K.
Mark Augusti, chief executive officer and president of Conformis, said: “The latest ratings from ODEP provide continued independent validation of the Conformis design philosophy and our unique, customised manufacturing capabilities. Our goal is to provide a better experience where it matters most – in patients’ lives – and the ODEP rating reflects the high performance of our products at NHS facilities throughout the United Kingdom.”
The 7A rating awarded to the iTotal CR Knee Replacement System is based on seven years of performance data provided by Conformis to the panel. ODEP ratings provide a simple, independently verified assessment of the performance of an implant, assessed against national clinical best practice guidelines. This enables clinicians to choose only those implants that comply with these national guidelines and provides peace of mind to patients as they evaluate implant choices with their doctors.
Mr. Stuart Roy, consultant trauma and orthopaedic surgeon at Spire Hospital Cardiff and Royal Glamorgan Hospital in Cardiff (South Wales), United Kingdom, said: “The updated performance ratings complement what I have already learned from my years of using Conformis knee implants – namely, Conformis provides superior fit and extremely high-quality outcomes. I continue to recommend the Conformis iTotal CR knee for many of my patients.”
Only products that demonstrate compliance with NICE guidance are eligible for ODEP ratings. To date, more than 70 surgeons in the UK have implanted more than 1,300 iTotal CR implants with a seven-year cumulative revision rate of 2.2% versus 2.5% for all other total knee replacements in the National Joint Registry at the same 7-year post-operative time-point. For Conformis’ iTotal CR with the iPoly XE insert, more than 40 surgeons have treated more than 700 patients, and the five-year revision rate has been 1.2% versus 2.1% for the rest of the NJR.
