Press release - May 21, 2008
Bioimpedance Measurement Acknowledged in Irish Lymphedema Guidelines
Bioimpedance technology has been acknowledged by the Irish Clinical Resource Efficiency Support Team (CREST)1 in its recently released (February 2008) Guidelines for the Assessment and Monitoring of Lymphedema which rates bioimpedance as the only technology high in sensitivity and specificity. CEO of ImpediMed Limited Mr Greg Brown has welcomed the Guidelines as a significant step forward in the recognition of ImpediMed’s bioimpedance technology. “The guidelines demonstrate the shifting treatment focus for lymphedema from a reactive approach to one focused on early detection and early intervention. Mr Brown said it was particularly pleasing to note the Guidelines recommend the use of a baseline measurement on patients prior to surgery or radiotherapy. “This surveillance method of diagnosis and treatment mirrors recommendations contained in the recently published ground breaking study by the US NIH (National Institutes of Health) published online in the top tier international journal Cancer, the official journal of the American Cancer Society.”2; “According to data from the NIH study the preoperative assessment of breast cancer patients for sub-clinical lymphedema enables the early detection and successful treatment of the debilitating condition.” Mr Brown said the Irish Guidelines noted that, although bioimpedance is not generally available in Northern Ireland, it is looking to be a promising, effective and efficient way of assessing and monitoring lymphedema and should be considered for use in the longer term (over the next five years). It should be noted that ImpediMed devices are currently being used in many of the centres involved in establishing the Irish Guidelines. ImpediMed has the only FDA cleared device for the clinical assessment of lymphedema in the arm. The FDA cleared L-Dex XCA is a device that longer term will be targeted to the home care market. The recently filed L-Dex U400 is the device that once FDA cleared will be targeted to surgeons, oncologists and therapists and the company hopes to launch this device by the fourth quarter of this year. ImpediMed’s technology has been shown in clinical trials to detect lymphoedema in breast cancer survivors in the range of 1 to 10 months earlier than clinically observable symptoms. Further information on the Irish Guidelines can be found at: www.crestni.org.uk ENDS For more information contact: Mel Bridges ImpediMed Limited Chairman Office: +61-7-3423-1777 Greg Brown ImpediMed Limited CEO Office: +61-7-3423-1777 John Lamont Phillips Group Media Relations Mobile: +61-408-737-450 CREST. Guidelines for the Diagnosis, Assessment and Monitoring of Lymphoedema. February, 2008. ISBN 978-1-903982-32-7 National Institutes of Health, National Naval Medical Center, George Mason University Study Published in Cancer demonstrates the importance of physicians’ shift to baseline measures and ongoing ‘Surveillance’ Model for the successful management of common, debilitating condition. About ImpediMed Limited ImpediMed Limited develops and globally markets medical device systems for use in non-invasive screening and monitoring of human disorders and diseases. ImpediMed’s primary product range consists of a number of medical devices that enable the early detection and monitoring of secondary lymphoedema in cancer survivors before the onset of symptoms that are detectable using the most commonly used clinical technique. ImpediMed has the only medical device with an FDA clearance in the United States for the clinical assessment by Health Care Providers of secondary lymphoedema in the arm.