Press Releases

New research shows patients at risk of developing breast cancer-related lymphedema should be monitored for minimum of three years following completion of cancer treatment

CARLSBAD, Calif., April 11, 2024 /PRNewswire/ -- ImpediMed, a leader in medical technologies to clinically monitor and manage fluid and body composition, announced today that it will present new results from a breast cancer-related lymphedema study during a poster session at the American Society of Breast Surgeons (ASBrS) Annual Meeting in Orlando, FL on Friday, April 12, 2024.

The study, titled "Timing of Breast Cancer-related Lymphedema Development Over Three Years: Observations from a Large, Prospective Randomized Screening Trial," revealed that patients at risk of developing breast cancer related lymphedema (BRCL) should continue to be monitored for three years following the completion of cancer treatment, as patients could trigger at any time over this period.

"Chronic breast cancer-related lymphedema can represent a risk to patients who have undergone breast cancer treatment with meaningful impact on their quality of life," said Chirag Shah, MD, Co-Director of the Comprehensive Breast Cancer Program, Cleveland Clinic, lead author of the study, and scientific adviser to ImpediMed. "Early detection and intervention are critical to preventing chronic lymphedema. The intent of our analysis was to illustrate that patients can develop breast cancer-related lymphedema from a few months to a few years after treatment, emphasizing the need for careful screening for years following treatment."

The results are part of PREVENT, the largest randomized control trial to assess lymphedema prevention, in 1200 women, which monitored progression to BCRL following intervention for BCRL assessed by both bioimpedance spectroscopy (BIS) and a tape measure, demonstrating lower progression to chronic lymphedema with early detection using BIS and intervention versus using tape measure.

ImpediMed Chief Medical Officer, Steven L. Chen, MD, MBA, one of the study's authors, will present the findings at ASBrS.

"This study confirms that patients continue to be at risk for developing BCRL years after treatment and thus may continue to progress to chronic breast cancer-related lymphedema (cBCRL) even 3 years after surgery," said Chen. "We look forward to discussing this important research with our colleagues in Orlando."

Lymphedema, a common consequence of cancer treatment, poses significant challenges in healthcare. According to the American Cancer Society 58% of cancer patients diagnosed with breast cancer, melanoma, or pelvic area cancers are at risk for developing limb lymphedema, and over 80% of breast cancer patients are at risk.

ImpediMed has the only FDA-cleared BIS technology for the clinical assessment of lymphedema. The Company's SOZO® Digital Health Platform is broadly accepted and recognized for effective and accurate screening of lymphedema, with US payors now providing coverage for over 140 million covered lives.

About SOZO Digital Health Platform

SOZO, the world's most advanced, non-invasive bioimpedance spectroscopy (BIS) device, delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds. Using ImpediMed's BIS technology, SOZO measures 256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz. Results are available immediately online for easy data access and sharing across an entire healthcare system. The FDA-cleared, CE-marked and ARTG-listed digital health platform aids in the early detection of secondary lymphedema, provides fluid status for patients living with heart or renal failure, and can be used to monitor and maintain overall health – all on a single device.

About ImpediMed

ImpediMed is a leading global medical technology company that designs and manufactures medical devices that employ bioimpedance spectroscopy (BIS) technology for use in the noninvasive clinical assessment and monitoring of fluid status and tissue composition in patients. The company consistently drives innovation, directing its primary efforts toward addressing the specific challenges and devastating burden of secondary lymphedema with a focus on breast cancer-related lymphedema (BCRL). With its SOZO® Digital Health Platform and L-Dex®, ImpediMed is the only company to offer an FDA-cleared technology that uses BIS and is setting new standards in early detection and management of BCRL. For more information, please visit www.impedimed.com.

About the PREVENT Trial

The PREVENT trial is a pivotal study and the largest randomized controlled trial to assess lymphedema prevention. The study enrolled 1,200 patients across 10 trial sites in the US and Australia, involving 13 hospitals, including Vanderbilt University, Mayo Clinic and MD Anderson. The trial was conducted over six and a half years and patients were followed for up to three years, with the primary aim to determine if early intervention in patients with subclinical detection of extracellular fluid accumulation via bioimpedance spectroscopy results in a lower rate of lymphedema progression versus the rate when tape measure is used for subclinical detection. The manuscript is published in Lymphatic Research and Biology.

The results of the trial demonstrated that patients with early detection with L-Dex™ technology and at-home intervention with compression garments resulted in a 7.9% rate of chronic lymphedema compared to a 19.2% rate of chronic lymphedema using tape measure. The difference is statistically significant (p=0.016) as well as being clinically significant for patients and clinicians. This represents an absolute reduction of 11.3% and relative reduction of 59% in lymphedema progression at three years.

Media Contact:

Jodi Perkins
Amendola Communications, on behalf of ImpediMed
jperkins@acmarketingpr.com

SOURCE ImpediMed