Four-Year Data from the UK National Joint Registry Highlights High Survivorship in Patients Treated with the Conformis iTotal CR
Data Shows a Low Cumulative Percent Revision of 0.5% for Conformis Patients vs 1.9% for all Total Knee Replacement Patients
BILLERICA, Mass., March 07, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants designed and manufactured to fit and conform to each patient’s unique anatomy, today announced new data showing that patients treated with the Conformis iTotal CR knee implant experienced a cumulative revision rate of 0.5% at four years compared to a 1.9% cumulative revision rate at the same time-point, among all patients who underwent knee replacement.1 Results are summarized in a February 2018 report from Beyond Compliance, based on data available in the National Joint Registry (NJR) in the U.K.
In total or partial knee arthroplasty, revision surgery may be required to address problems, including loosening, instability, and infection following an original implant procedure. The summary data in this report includes 576 iTotal implant procedures in 504 patients treated at 46 different centers in the U.K.1 Among all patients treated with Conformis iTotal implants, only three patients (0.5%) required revision surgery up to four years following surgery.1
“The new four-year data highlighting the low risk of revision surgery for patients treated with Conformis iTotal implants provides strong clinical evidence reinforcing survivorship of our implant technology,” said Mark Augusti, President and CEO of Conformis. “We are pleased to add this data summary to our growing body of clinical evidence supporting the many benefits our product provides to patients. Announcement of this new safety data is on the heels of our most recent announcement that the Orthopaedic Data Evaluation Panel (ODEP) in the U.K. awarded the Conformis iTotal CR knee replacement system a ‘3A’ rating. This positive 3A rating is based on strong evidence of implant performance over a three-year period; including low revision rates noted in this report.” http://www.odep.org.uk/product.aspx?pid=4305
“When adopting new technology, surgeons must assess how the new technology maintains established standards for safety and efficacy, “said Raj Sinha, MD, PhD from S.T.A.R. Orthopedics in Rancho Mirage, CA. “This recent data from the UK demonstrates that the Conformis iTotal CR provides excellent survivorship, evidenced by the low revision rates. This continues to prove the considerable benefits of treating my patients with the Conformis iTotal Knee Replacement System.”
Conformis iTotal is the only patient-conforming total knee replacement for which the implant design and manufacture is based on each patient’s anatomy and offers effective patient based advantages compared to standard off-the-shelf implants, including patient conforming sizes and better bone preservation. Study results from Levengood et. al. published in the peer-reviewed orthopedic journal, The Journal of Knee Surgery, in December 2017 showed that 100% of patients treated with iTotal CR achieved mechanical alignment in the target range of +/-3%. Neutral mechanical limb alignment (alignment within +/-3 °) has previously been linked to better long-term survivorship in TKA, while poor alignment has been linked to higher rates of implant failure.
“As a surgeon, we always strive to provide the best alternatives for our patients,” said Mr. Ian McDermott, MB BS, MS, FRCS (Tr&Orth), FFSEM(UK) affiliated with London Bridge Hospital in London, United Kingdom. “This 4-year National Joint Registry data confirms the positive early results I am seeing with my Conformis patients with respect to survivorship, in addition to published studies that continue to show effective positive outcomes I am seeing with faster recovery, improved kinematics and overall patient satisfaction.”
About Conformis, Inc.
Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are designed and manufactured to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of patient conforming total and partial knee systems that include sterilized single-use instruments delivered in a single package to the hospital. Conformis owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover patient-specific implants and instrumentation for all major joints.
For more information, visit www.conformis.com.
1 Implant Summary Report for the iTotal G2 XE and iTotal G2 (Bicondylar tray). Beyond Compliance database February 11, 2018, pages 19-20. This report has been produced by Northgate Public Services (UK) Ltd. (NPS) based on data collected by the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.
Cautionary Statement Regarding Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Conformis, including statements about the ability to offer implants to patients in the United Kingdom, that potential clinical benefits or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Conformis views as of the date hereof. Conformis anticipates that subsequent events and developments may cause Conformis’s views to change. However, while Conformis may elect to update these forward-looking statements at some point in the future, Conformis specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Conformis’ views as of any date subsequent to the date hereof.
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