Additional Data Published in "Annals of Surgical Oncology" Recommends Extended Monitoring of Lymphedema for Breast Cancer Patients

Study recommends that patients be monitored a minimum of three years after cancer treatment

CARLSBAD, Calif., July 16, 2024 /PRNewswire/ -- Some breast cancer patients remain at risk for developing lymphedema well after their cancer treatment is concluded and should be monitored a minimum of three years, according to data published in the Annals of Surgical Oncology.

Lymphedema, a disabling swelling that is 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. Additionally, over 80% of breast cancer patients can be at risk based on the type of cancer treatment they have received.

Among the paper's co-authors are Steven Chen, MD, MBA, Chief Medical Officer of ImpediMed, a pioneer in the field of medical technology that has the only FDA-cleared bioimpedance spectroscopy (BIS) technology for the clinical assessment of breast cancer-related lymphedema (BCRL) - the SOZO^® Digital Health Platform.

"BCRL can develop years after cancer treatment is concluded and can progress from the subclinical stage, where intervention is possible to reverse progression, to chronic lymphedema, where this can become a lifelong condition," Chen said. "This study highlights the importance of continued monitoring for BCRL post cancer treatment for at least 3 years using the most accurate technology available for early detection."

Evidence from the study, titled "Timing of Breast Cancer-related Lymphedema Development Over Three Years: Observations from a Large, Prospective Randomized Screening Trial," is drawn from PREVENT, the largest randomized control trial for lymphedema assessment. PREVENT monitored progression to BCRL following intervention for BCRL assessed by BIS versus a tape measure. The results demonstrated that early detection and intervention using BIS resulted in lower progression to chronic lymphedema compared to using a tape measure. The results provide additional evidence supporting the need for continued lymphedema follow-up and the use of BIS as the preferred method, when available, as stated in national and international clinical practice guidelines.

ImpediMed's platform is broadly accepted and recognized for effective and accurate screening of lymphedema, with U.S. payors now providing coverage for over 140 million covered lives.

"Late-developing chronic breast cancer-related lymphedema is a particularly harsh blow to patients who thought they had put their treatment behind them," 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 the keys to preventing chronic lymphedema. By showing that patients can develop breast cancer-related lymphedema from a few months to even years after treatment, this analysis highlights the need for careful screening for years following treatment."

The study comes on the heels of new guidance from the Multinational Association of Supportive Care in Cancer (MASCC), which also underscored the importance of regular monitoring for BCRL using BIS.

The consensus-based recommendation by MASCC, coupled with supportive findings from the PREVENT trial, underscores the effectiveness of ImpediMed's technology in preventing the progression of lymphedema. The company's commitment to innovation and patient care is further evidenced by its active role in the medical community, including its participation in upcoming U.S. conferences and contributions to ongoing clinical research.

As ImpediMed continues to champion early lymphedema detection and prevention, its efforts are paving the way for a new standard in breast cancer survivorship care, ensuring that survivors can look forward to healthier, more comfortable futures.

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 lymphoedema, 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.

Media Contact:

Jodi Perkins
Amendola Communications, on behalf of ImpediMed
[email protected]

SOURCE ImpediMed