LymphScanner

EU Customers:

MDD Medical Device Class IIa in EU*: LymphScanner is a device intended to measure localized percentage water content (PWC) in lymphedema of human skin after surgery for breast cancer or gynecological cancers. Applicability ranges from undetectable preclinical lymphedema to advanced lymphedema. The device can be used to aid in forming a clinical judgement of skin edema at any soft tissue site of the body by a health care professional.

USA Customers:

FDA clearance 510(k) in USA*: LymphScanner is a device utilizing inter-aim ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in adult women. The device is not intended to make a diagnosis or predict arm lymphedema.

*The LymphScanner is intended to be operated by healthcare professionals in professional health care facilities.

LymphScanner is a device used for the assessment and detection of lymphedema. It measures localized tissue water content and displays a Percentage Water Content (PWC) value.

1. Operation Principle: LymphScanner measurement depth is effectively about 2.5 mm which ideal for detecting elevated tissue water content due to dermal backflow on skin. The measured value is the tissue dielectric constant (TDC), that is converted into percentage water content (PWC) reading. The PWC threshold ratios ​​between the measurement site and the reference site are used as an indicator for the assessment of lymphedema. Elevated PWC ratio between measurement and reference site indicates increased tissue water content. Changes in tissue water content are typically associated with lymphedema.
2. Non-invasive Measurements: LymphScanner measurements are non-invasive and totally painless, and there are no limitations on repeated measurements that can be performed from the same skin site. The measurement values are displayed in seconds after placing the probe on skin. The anatomical measurement sites are typically recorded to obtain reliable follow-up measurements from the same skin sites to monitor the treatment results.
3. Early Detection of Lymphedema: LymphScanner is particularly useful for the early detection of lymphedema, due to the sensitivity in detecting minor changes in local tissue water content. Lymphedema can be detected already in subclinical stage when no signs or symptoms are detectable by conventional methods. Early detection is known to be important for the treatment and quality of life of the lymphedema patients.
4. Lymphedema Management: LymphScanner is also suitable for monitoring the progression of lymphedema in order to evaluate the effectiveness of treatment over time. The objective measurements help the health care professional in adjusting the individual treatment plan if needed. The numeric values are also often considered to motivate patients to stick with the treatment plan as the results are easy to understand.
5. Ease of Use: LymphScanner is designed to be user-friendly, allowing quick and easy measurements. LymphScanner is ready to be used upon delivery, and no separate implementation is needed. Short training provided by the manufacturer is typically enough to grasp the measurement concept.
6. Objective Data: LymphScanner provides quantitative and objective data that can be followed over time. This data allows more precise and personalized treatment plans in assessing and managing the lymphedema. The measurements are not user-dependent, allowing the standardization of lymphedema assessments.
7. Measurement Sites: The device can be used basically in all body sites, such as the arms, legs, breast, truncal area, and head and neck region.*

LymphScanner is an excellent tool for lymphedema care, offering a quick, accurate, and patient-friendly assessments. LymphScanner mesurements can be used independently or along with other clinical methods, such as circumference measurements and palpation. Comprehensive clinical assessment, considering the patient’s overall health status and lymphedema stage is also recommended.

*see section “Indication of Use” above to check your local regulatory status