Conformis Knee Replacement System Awarded ‘3A’ Rating in UK

Conformis Inc., a medical technology company that offers joint replacement implants designed and manufactured to fit and conform to each patient’s unique anatomy, today announced that the Orthopaedic Data Evaluation Panel in the United Kingdom (ODEP) awarded the Conformis iTotal CR knee replacement system a “3A” rating. The 3A rating is based on strong evidence of implant performance over three years, including low revision rates as indicated in the United Kingdom’s National Joint Registry.
 
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 theNational Institute for Health and Care Excellence (NICE) in the United Kingdom. The 3A rating is based on three-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.
 
“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, UK. “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, Mr. Fahad G. Attar, MBChB, FRCS, consultant trauma and 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.”
 
“The ODEP awarded the Conformis iTotal CR system a 3A rating based in part on positive implant survivorship and performance data from the UK National Joint Registry at three years’ post-surgery,” said Mark Augusti, Chief Executive Officer 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 3A rating also provides an opportunity for Conformis to expand our product offering to more patients receiving their healthcare in NHS facilities.”
 
More information on the ODEP can be found on their website at http://www.odep.org.uk/ODEPExplained.aspx.