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ImpediMed announcement: study from the Journal of Clinical Oncology verifies the need for pre-emptive care of lymphedema

Wednesday, 18 March 2009
ImpediMed announcement: study from the Journal of Clinical Oncology verifies the need for pre-emptive care of lymphedema

19 March 2009: ImpediMed would like to bring to the attention the publication: “Incidence, Treatment Costs, and Complications of Lymphedema After Breast Cancer Among Women of Working Age: A 2-Year Follow-Up Study”, published on the 16th March 2009 in the online edition of the Journal of Clinical Oncology1. The company feels that this is a significant study, as it demonstrates both the psychosocial impact of lymphedema and the impact of the direct costs associated with lymphoedema in breast cancer patients in the first two years post operation.

The authors state that “Upper extremity lymphedema is one of the most dreaded sequelae of breast cancer (BC) treatment.2, 3 The psychosocial impact of lymphedema has been described to be as distressing as the initial diagnosis of BC; patients with breast cancer–related lymphedema (BCRL) have been found to have a lower quality of life, a higher level of anxiety or depression, a higher likelihood of chronic pain and fatigue, and greater difficulty functioning socially and sexually compared with BC women without lymphedema.4-11 Reported incidence rates of BCRL vary from 4% to 56%3, 5, 12-21; the true incidence is difficult to assess because of varying criteria used to define lymphedema and the duration of follow-up across studies.22-24”

The publication established that the costs of managing a patient with breast cancerrelated lymphoedema (BCRL) were significantly higher (in the range of $US 14,877 to $US 23,167 over the two year study period), than those breast cancer patients without lymphoedema. According to the authors, “This study likely underestimates the cost of BCRL. The onset of lymphedema varies in time; although we followed our study cohort for two years, the costs of BCRL for women who developed the condition late within that period would not reflect the total financial burden of BCRL.” The conclusion of the study was, “Although the use of claims data may underestimate the true incidence of lymphedema, women with BCRL had a greater risk of infections and incurred higher medical costs. The substantial costs documented here suggest that further efforts should be made to elucidate reduction and prevention strategies for BCRL.”

Chief Executive Officer Greg Brown said, “ImpediMed’s business model is supported by the conclusion of this study. We are very focused on the use of the L-DexTM U400 for pre-emptive care; both for pre-operative and post-operative surveillance of patients.

“The L-Dex U400 is the first FDA cleared device designed to aid surgeons, oncologists and therapists to detect the earliest stages of the disorder. It was demonstrated last year (June Cancer publication25) that early detection and early intervention can successfully treat lymphoedema and potentially prevent the progression of the disorder. This publication is a powerful health economic support to the benefits of the preemptive care our technology can help facilitate.

“This publication should support the company’s efforts in establishing coverage for healthcare professionals for the reimbursement of ImpediMed technology in the US market,” he said.

The report may be accessed at: http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2008.18.3517
1. Incidence, Treatment Costs, and Complications of Lymphedema After Breast Cancer Among Women of Working Age: A 2-Year Follow-Up Study Ya-Chen Tina Shih, Ying Xu, Janice N. Cormier, Sharon Giordano, Sheila H. Ridner, Thomas A. Buchholz, George H. Perkins, Linda S. Elting JCO Mar 16 2009: doi:10.1200/JCO.2008.18.3517
2. Hayes SC, Janda M, Cornish B, et al: Lymphedema after breast cancer: Incidence, risk factors, and effect on upper body function. J ClinOncol 26:3536-3542, 2008
3. Petrek JA, Pressman PI, Smith RA: Lymphedema:Current issues in research and management.CA Cancer J Clin 50:292-307, 2000
4. Armer JM, Porock D: Self-management of fatigue among women with lymphedema. Lymphology35:208-213, 2002
5. Beaulac SM, McNair LA, Scott TE, et al:Lymphedema and quality of life in survivors of early-stage breast cancer. Arch Surg 137:1253-1257, 2002
6. Heiney SP, McWayne J, Cunningham JE, etal: Quality of life and lymphedema following breast cancer. Lymphology 40:177-184, 2007
7. Kakuda JT, Stuntz M, Trivedi V, et al: Objective assessment of axillary morbidity in breast cancer treatment. Am Surg 65:995-998, 1999
8. McWayne J, Heiney SP: Psychologic and social sequelae of secondary lymphedema: A review. Cancer 104:457-466, 2005
9. Pyszel A, Malyszczak K, Pyszel K, et al: Disability,psychological distress and quality of life in breast cancer survivors with arm lymphedema.Lymphology 39:185-192, 2006
10. Voogd AC, Ververs JM, Vingerhoets AJ, et al:Lymphoedema and reduced shoulder function as indicators of quality of life after axillary lymph node dissection for invasive breast cancer. Br J Surg 90:76-81, 2003
11. Grabsch B, Clarke DM, Love A, et al: Psychological morbidity and quality of life in women with advanced breast cancer: A cross-sectional survey.Palliat Support Care 4:47-56, 2006
12. Coen JJ, Taghian AG, Kachnic LA, et al: Risk of lymphedema after regional nodal irradiation with breast conservation therapy. Int J Radiat Oncol BiolPhys 55:1209-1215, 2003
13. Golshan M, Martin WJ, Dowlatshahi K: Sentinel lymph node biopsy lowers the rate of lymphedema when compared with standard axillary lymph node dissection. Am Surg 69:209-211,2003
14. Herd-Smith A, Russo A, Muraca MG, et al:Prognostic factors for lymphedema after primary treatment of breast carcinoma. Cancer 92:1783-1787, 2001
15. Kosir M, Rymal C, Koppolu P, et al: Surgical outcomes after breast cancer surgery: Measuring acute
lymphedema. J Surg Res 95:147-151, 2001
16. Meric F, Buchholz TA, Mirza NQ, et al:Long-term complications associated with breast conservation surgery and radiotherapy. Ann Surg Oncol 9:543-549, 2002
17. Paskett ED, Naughton MJ, McCoy TP, et al: The epidemiology of arm and hand swelling in premenopausal breast cancer survivors. Cancer Epidemiol Biomarkers Prev 16:775-782, 2007
18. Schijven MP, Vingerhoets AJ, Rutten HJ, et al: Comparison of morbidity between axillary lymph node dissection and sentinel node biopsy. Eur ; J Surg Oncol 29:341-350, 2003
19. Schrenk P, Rieger R, Shamiyeh A, et al: Morbidity following sentinel lymph node biopsy versus axillary lymph node dissection for patients with breast carcinoma. Cancer 88:608-614, 2000
20. Sener SF, Winchester DJ, Martz CH, et al:Lymphedema after sentinel lymphadenectomy for breast carcinoma. Cancer 92:748-752, 2001
21. Tengrup I, Tennvall-Nittby L, Christiansson I,et al: Arm morbidity after breast-conserving therapy for breast cancer. Acta Oncol 39:393-397, 2000
22. Armer JM: The problem of post-breast cancer lymphedema: Impact and measurement issues.
Cancer Invest 23:76-83, 2005
23. Hayes S, Janda M, Cornish B, et al: Lymphedema secondary to breast cancer: How choice of measure influences diagnosis, prevalence, and identifiable risk factors. Lymphology 41:18-28, 2008
24. Williams AF, Franks PJ, Moffatt CJ: Lymphoedema: Estimating the size of the problem. Palliat
25. Med 19:300-313, 2005Preoperative Assessment Enables the Early Diagnosis and Successful Treatment of Lymphedema,Cancer Vol 112/ Issue 12, June15, 2008 pp. 2809-2819.

For further information contact:
Greg Brown Impedimed CEO +61-7-3860-3700

About ImpediMed
ImpediMed Ltd. is the world leader in the development and distribution of medical devices employing Bioimpedance Spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status. ImpediMed’s primary product range consists of a number of medical devices that aid surgeons, oncologists, therapists and radiation oncologists in the clinical assessment of patients for the potential onset of secondary lymphoedema. Pre-operative clinical assessment in breast cancer survivors, before the onset of symptoms, may prevent the condition from becoming a lifelong management issue and thus improve the quality of life of the cancer survivor. ImpediMed had the first medical device with an FDA clearance in the United States to aid health care professionals in the clinical assessment of secondary lymphoedema of the arm in female breast cancer patients. For more information, visit. www.impedimed.com.