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ImpediMed Fact Sheet
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ImpediMed’s primary product range (L-Dex)TM consists of a number of medical devices that
enable the early detection and monitoring of secondary lymphoedema (extracellular fluid) in
cancer survivors before the onset of symptoms that are detectable using the most commonly
used clinical technique.1
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Lymphoedema is a condition that may afflict cancer survivors, including but not limited to the
survivors of breast cancer. Secondary lymphoedema most commonly arises as a result of
surgical removal of the lymph nodes or damage or destruction of lymph nodes due to
radiation therapy, trauma or parasites. It can result in gross irreversible swelling of the
woman’s arm because of damage or removal of lymph nodes during breast cancer
treatment. Approximately 10% of the body’s fluids are moved by the lymphatic system so
injury or damage to the system can seriously impact a patient’s health as well as their quality
of life. Lymphoedema has both physiological and psychological impact on these patients.
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The standard of care in today’s medical paradigm is to diagnose lymphoedema in breast
cancer patients once the arm volume has increased by between 200 and 400 ml. There is no
agreed standard presently that is accepted globally. The arm difference is assessed with
volumetric measures such as a tape measure which in many cases does not follow
standardised measurement criteria and also provides little in terms of direct measurement of
the extracellular fluid. Volume measures are also more likely to be affected by changes in the
limb that are NOT due to lymphoedema. Accordingly, a survivor may already be at an
irreversible “Stage 2” lymphoedema before the diagnosis is made.
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Using bioimpedance spectroscopy to assess extracellular fluid, L-Dex devices are targeted to
change the medical paradigm around lymphoedema detection. This new model requires presurgical baseline assessment and regular quarterly assessment for the first 2 – 3 years; or
more often if any signs of lymphoedema are present or if pre and post treatment
assessments (e.g. radiation, chemotherapy) are desired. As the risk of lymphoedema is
present for life following an intervention that diminishes the lymph transport system, the
survivor will need to be assessed periodically for signs and if present, intervention may be
instigated.
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Ground breaking research from the US National Institutes of Health (NIH) published in the
journal “Cancer” in June 2008 showed preoperative assessment of breast cancer patients
enabled early diagnosis and successful treatment of lymphoedema,2 affording patients a far
greater quality of life, and if caught early enough, substantially reducing the costs associated
with the ongoing care of patients who have progressed to a later stage of lymphoedema.3
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Many centres and private therapists and surgeons in Australia are using the model proposed
above, including the NSW Breast Cancer Institute, and the Royal Women’s Hospital in
Brisbane, but more are impeded by the lack of reimbursement in Australia. Following a
product launch in late 2008 in the USA, around 45 surgeons from the American Society of
Breast Surgeons (ASBS) including board members such as Dr Eric Whitacre are using L-Dex
devices in their practices with reimbursement available under a miscellaneous code at this
point, with a technology specific code expected in the future. In addition, the introduction of
an American Society of Breast Surgeons (ASBS) patient registry is an important initiative this
year because it could mean up to 200-300 surgeons using L-Dex devices soon.
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Steven Schonholz, M.D., a breast surgeon and medical director of the Breast Cancer Center
at Mercy Medical Center in Springfield, Mass., comments: "The problem with lymphedema is
that there hasn’t been an easy way to detect the condition before it is apparent to the doctor
and patient. Today there are new, non-invasive methods that have enabled me to identify the
condition and begin treatment long before the patient is aware of a problem. If patients aren't
treated at the earliest possible indication of lymphedema, it is less likely to be effectively
treated, and the condition may require life-long costly treatment and, more importantly, have
an enormous impact on a woman's self-esteem, function and quality of life."
"Optimal management of lymphedema requires diagnostic tools that are sensitive to
subclinical changes in tissue," said Dr. Schonholz, who uses an L-Dex device in his practice.
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In total, there are about 300,000 people in Australia who have some form of lymphoedema.
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According to the National Breast and Ovarian Cancer Centre (NBOCC), “The incidence of
secondary lymphoedema following treatment for cancer in Australia is unknown and it is
likely that its prevalence is underestimated. Incidence estimates for various cancers range
between 5% and 66%. 70-80% of those who have lymphoedema after breast cancer present
within the first 12 months following treatment. The incidence of lower-limb secondary
lymphoedema following inguinal node surgery seems to be at least as common as upperlimb secondary lymphoedema following axillary node surgery. Lower-limb secondary
lymphoedema also seems to be more common following treatment for particular cancers
(e.g. cancer of the vulva, as compared with ovary). Taken together, conservative estimates
suggest that 20% of breast, genitourinary, gynaecological, or melanoma survivors will
experience secondary lymphoedema. This equates to more than 8000 new cases per year
in Australia, highlighting the potential public health burden of cancer-related secondary
lymphoedema.”4
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ImpediMed L-Dex devices have TGA clearance and the L-Dex U400 device can be used to
assess unilateral lymphoedema of both the arm and leg. 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.
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A recent cost analysis publication from the USA documented the increase in medical costs in
a two year period for breast cancer survivors with lymphoedema compared to those without
lymphoedema.3 This study used US billing codes to determine the cost analysis and found
that on average breast cancer survivors with lymphoedema had increased costs ranging
from US$14 877 to US$23 167. The study also points out that these patients are more at risk
of infections and cellulitis that would further increase costs. By decreasing the severity of
lymphoedema through early detection and early intervention as was reported in the NIH
publication2 these costs could be reduced and L-Dex/early assessment could be the vehicle
for these reductions.
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Cornish, B.H., et al., Early diagnosis of lymphedema using multiple frequency bioimpedance. Lymphology, 2001. 34(1):
p. 2-11.
Stout Gergich, N.L., et al., Preoperative assessment enables the early diagnosis and successful treatment of
lymphedema. Cancer, 2008. 112(12): p. 2809-19.
Shih, Y.C., et al., Incidence, Treatment Costs, and Complications of Lymphedema After Breast Cancer Among Women
of Working Age: A 2-Year Follow-Up Study. J Clin Oncol, 2009.
NBOCC, Review of research evidence on secondary lymphoedema: Incidence, prevention, risk factors and treatment,
S. Hayes, Editor. 2008, National Breast and Ovarian Cancer Centre. Review of research evidence on secondary
lymphoedema: Incidence, prevention, risk factors and treatment, NBOCC, Surry Hills, NSW, 2008.
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