Clarifi — SFDI Powering Value-Based Care

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 for 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)).

Download the Clarifi® Imaging System Brochure here.

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.