Study on Efficacy of L-Dex® in Routine Clinical Practice Published
BRISBANE, Australia and CARLSBAD, Calif., Sept. 15, 2016 /PRNewswire/ — ImpediMed Limited (ASX: IPD), a global provider of medical technology to measure, monitor and manage fluid status and body composition, today announced that a new study published in the journal Frontiers in Oncology demonstrates the impact L-Dex® can have on patients at risk for breast cancer-related lymphedema (BCRL).
The retrospective study, conducted by two surgical oncologists, Alison Laidley, MD, of Texas Breast Specialists of Dallas, Texas, and Beth Anglin, MD, of North Texas Surgical Oncology in Plano, Texas, followed 326 patients with a median follow-up time of 21.7 months. The patients had undergone either an axillary lymph node dissection (ALND) or a sentinel lymph node biopsy (SLNB).
All patients had a pre-operative baseline measure and at least two follow-up visits post-operatively. Patients were surveilled with L-Dex measurements as part of their routine post-operative follow-up. The cumulative incidence of sub-clinical lymphedema was 4.3 percent for the SLNB patients and 26.7 percent for ALND patients. L-Dex allowed for early intervention for these patients resulting in a reduction of persistent, clinical lymphedema by 99.5 percent and 91.4 percent, respectively.
The study concluded, “The results of this retrospective study demonstrate that L-Dex assessments can be incorporated into routine breast cancer programs as part of follow-up. This is critically important given the recent changes in the NCCN (National Comprehensive Cancer Network®) survivorship guidelines for post-treatment follow-up care for breast cancer patients establishing that health-care providers ‘educate, monitor, and refer for lymphedema management’.”
About the L-Dex System
L-Dex is the first product of its kind to utilize bioimpedance spectroscopy (BIS), a non-invasive system for accurately measuring tissue composition and fluid status. Through electrodes placed on the arm and leg, L-Dex sends a small, imperceptible current using 256 frequency spectra through tissue measuring extracellular fluid.
Using a scoring system, oncologists, breast cancer surgeons and other healthcare providers can determine in seconds the amount of resistance from one point to the other and identify the onset of extracellular fluid accumulation, which may assist in the identification of lymphedema at an earlier point in time.
A randomized controlled study using L-Dex is currently underway at six leading cancer centers, including the Vanderbilt-Ingram Cancer Center, University of Texas MD Anderson Cancer Center, Mayo Clinic, University of Kansas Cancer Center, VCU Massey Cancer Center and Macquarie University.
Interim results of this study will be released in late 2016, increasing the clinical evidence that supports the vital role of BIS in early identification of lymphedema in patients being treated for breast cancer and other cancers.
“As we await the results of the post-approval L-Dex study currently underway, we are pleased at the publication of these important and positive clinical data for L-Dex,” said Richard Carreon, Managing Director and Chief Executive Office of ImpediMed.
For more information on the L-Dex system for early assessment of lymphedema, patients and physicians may visit www.impedimed.com or call toll-free 877-247-0111.
Founded and headquartered in Brisbane, Australia with U.S. offices in Carlsbad, Calif., and Bloomington, Minn., ImpediMed is the world leader in the development and distribution of medical devices employing bioimpedance spectroscopy (BIS) technologies for use in the noninvasive clinical assessment and monitoring of fluid status in patients. ImpediMed has the first medical device with FDA clearance in the U.S. to aid healthcare professionals to clinically assess secondary unilateral lymphedema of the arm and leg in women and the leg in men.
For additional information, visit www.impedimed.com.