Modulim’s Clarifi® Imaging System is the first non-contact, noninvasive microvascular assessment tool that uses a proprietary optical imaging technique — spatial frequency domain imaging (SFDI) — to provide insight into the delivery and extraction of oxygen to tissue. This information can help clinicians identify patients who are at-risk of vascular complications and pinpoint specific areas of potential compromised circulation before the presence of visible symptoms (e.g., ulceration).
Noninvasive microvascular assessment
Powered by SFDI, the Clarifi® Imaging System provides a more complete picture of tissue health by quantifying and mapping key microvascular biomarkers. Tissue oxygenation and perfusion data are displayed in the form of color-coded maps, which helps clinicians to quickly identify specific regions of interest.
Five key hemoglobin biomarkers are displayed on the Clarifi® user interface that provide insight into the oxygen delivery and extraction, including two unique perfusion biomarkers — superficial (papillary dermis) hemoglobin (HbT1) and subsurface (reticular dermis) hemoglobin (HbT2):*
The ability of Clarifi® to measure hemoglobin concentration and distribution in the papillary and reticular dermis reveals otherwise unavailable insight into the delivery of oxygen-carrying hemoglobin to the capillary network.
Equipped with this new information, Clarifi® helps clinicians identify at-risk patients earlier, quantify the nature and level of their risk, and target care to prevent complications.
*This information is intended for general guidance only and should not be interpreted as specific medical, diagnostic, or therapeutic recommendations.
Clarifi® is designed for use throughout the continuum of care
Clarifi® is a powerful new point-of-care imaging system designed to help clinicians identify potential compromised circulation that may indicate that a patient is at risk for an ulceration or infection.
As a fully integrated system, the Clarifi® Imaging System:
ο Has an intuitive user interface that displays crisp, color-coded maps of each biomarker.
ο Is easy to operate with a convenient handle and locking wheels.
ο Helps clinicians see tissue deeper than with the naked eye – up to 3 mm.
ο Has a large field of view (300 x 225 mm).
ο Removes variability from the evaluation process to support clinical decision-making.
ο Can be used as a patient education tool to help improve compliance.
ο Has the potential to improve outcomes and reduce costs across the continuum of care by enabling early detection and intervention.
ο Is easy and affordable for clinicians to integrate into their practice.
ο Is supported by reimbursement (Current Procedural Terminology (CPT®) Proprietary Laboratory Analyses (PLA) code (0061U)).
Clinical study: “Near-instant noninvasive optical imaging of tissue perfusion for vascular assessment”
A study published by Weinkauf et al. (Oct. 2018) in the Journal of Vascular Surgery “aimed to evaluate the ability of spatial frequency domain imaging (SFDI) … to assess lower extremity blood supply” compared to other noninvasive vascular tests including ankle-brachial index (ABI), toe-brachial index (TBI) and pedal Doppler waveforms. The study included 47 subjects with and without diabetes.
Findings included:
- SFDI ratio identifies peripheral artery disease (PAD) in subjects with diabetes:
- HbT2/HbT1 ratio is high for clinically validated PAD
- ABI correlation to PAD is poor in subjects with diabetes
- SFDI correlates with TBI in subjects with diabetes
- Evidence of elevated StO2 and reduced HbT1 due to diabetes-related arterio-venous shunting:
- Conditions result in under-extraction of oxygen and helps identify ulceration risk that ABI cannot identify.
- Demonstrated noninvasive measurement of circulatory shunting due to diabetes.
The study concluded “SFDI is a feasible, rapid, and easy-to-use widefield measurement of perfusion in a clinical setting. This first-of-use study suggests that the technology has potential to evaluate lower extremity perfusion in people with and without diabetes.”
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions. Clarif® Imaging System is not licensed for sale outside the U.S.
