Clinical evidence

ImpediMed’s bioimpedance spectroscopy (BIS) devices have been studied and clinically validated in the areas of lymphedema, heart failure, body composition and veterinary BIS research.

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Heart failure
Guidelines
Lymphedema prevention
L-Dex detection limit
Validation studies
Economics quality of life
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Sheila H. Ridner, Chirag Shah, John Boyages, Louise Koelmeyer, Nicolas Ajkay, Sarah M. DeSnyder, Sarah A. McLaughlin, Mary S. Dietrich

L-Dex, arm volume, and symptom trajectories 24 months after breast cancer surgery

These data support the need for long-term (24 months) prospective surveillance with frequent assessments (every 3 months) at least 15 months after surgery. Statistically significant convergence of symptom cluster scores with L-Dex unit change supports BIS as beneficial in the early identification of subclinical lymphedema.

Open access: Yes
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Lymphatic Education & Research Network

Centers of Excellence Program Description and Application

Bioimpedance spectroscopy as a tool for serial measurement and risk assessment

Open access: Yes
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Coroneos, C.J., et al.

Correlation of L-Dex Bioimpedance Spectroscopy with Limb Volume and Lymphatic Function in Lymphedema

The L-Dex ratio correlated with limb volume and clinical assessment of pitting edema, and physiologic measures of lymphatic function, and demonstrated face, construct, and criterion validity in response to intervention. These findings support the adjunctive use of the L-Dex ratio with limb volume measurements for objective diagnosis, evaluation of lymphedema severity, longitudinal serial evaluation of lymphedema, and response to conservative and surgical interventions.

Open access: No
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Ridner, S.H., et al.

A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis.

The results of this interim analysis demonstrate that patients undergoing surveillance with BIS had reduced but non-statistically significant reductions in the rates of progression requiring CDP compared with TM. These results are currently supportive of the need for subclinical detection and early intervention for patients with BCRL, with a 10% absolute reduction and 67% relative reduction in the rates of CDP. Further data with a longer follow-up than in this study is expected in the years to come and will strengthen these early, positive, practice-changing results.

Open access: Yes
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eviCore healthcare

Clinical Guidelines – Physical and Occupational Therapy Services

Bioimpedance listed under Validated Clinical tools for Diagnosing Lymphedema

Open access: Yes
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Accardi, A. et al.

Correlation of Limb Bioimpedance to Echocardiographic Indicators of Congestion in Patients with NYHA Class II/III Heart Failure.

The management of the chronic HF patient continues to challenge the primary care provider. Most HF patients are managed by body weight, physical examination findings, and intermittent diagnostics like echocardiography. These traditional methods of evaluation often fail to aid the practitioner in detecting fluid overload and impending decompensation. Staggering healthcare costs and financial penalties associated with 30-day readmission served as the impetus for this study. The use of SOZO is predicated on a correlation between impedance measurements and established measures of fluid. Despite the small study size, correlations of the SOZO device impedance measurements with IVC, RAP, and PAS suggest a possible alternative method to detect fluid overload. The results suggest that there is a relationship that could be used at low cost, is noninvasive, and easy to use. However, due to limitations to the study design, further research is needed to determine the utility of the SOZO device.

Open access: Yes
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SOZO®

SOZO, the world’s most advanced, noninvasive BIS device, incorporates L-Dex technology to aid in the assessment of secondary lymphedema and delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds.

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