Conformis iTotal® CR Knee Replacement System Awarded “5A” Rating from the Orthopaedic Data Evaluation Panel in the Unite...
February 19 2020 - 04:44PM
Conformis, Inc. (NASDAQ:CFMS), 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, today announced that the Orthopaedic Data Evaluation Panel
in the United Kingdom (ODEP) (http://www.odep.org.uk) 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
UK’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 (as explained in more detail at
http://www.odep.org.uk/ODEPExplained.aspx#2) 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 UK have implanted over 1,000 iTotal® CR
implants with a five-year cumulative revision rate of 1.8% versus
2.2% 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.” - Stuart Roy – Spire Cardiff
Hospital and Royal Glamorgan Hospital, 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.” - Ian McDermott – London Bridge
Hospital
“We are pleased to have received the ODEP 5A
rating,” 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 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.”
About Conformis, Inc.
Conformis is a medical technology company that
uses its proprietary iFit Image-to-Implant technology platform to
develop, manufacture, and sell patient-specific joint replacement
implants (individually sized and shaped, or personalized, to fit
each patient's unique anatomy). Conformis offers a broad line of
sterile, personalized knee and hip implants and single-use
instruments delivered to the hospital. In clinical studies, the
Conformis iTotal CR knee replacement system demonstrated superior
clinical outcomes, including better function and greater patient
satisfaction, compared to traditional, off-the-shelf implants.
Conformis owns or exclusively in-licenses issued patents and
pending patent applications that cover customized implants and
customized patient-specific instrumentation for all major
joints.
For more information,
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CONTACT
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ir@conformis.com
781.374.5598
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