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Clarifi

Clarifi™ is a user-friendly, noninvasive, non-contact device that measures critical hemoglobin biomarkers in tissue over a wide area—up to a full size 15 foot.

Powered by a proprietary optical imaging technique — spatial frequency domain imaging — Clarifi offers clinicians a fast, reliable, objective method of assessing tissue oxygen saturation and hemoglobin concentration and distribution in patients with compromised circulation. Oxygenation is a key biomarker to identify areas of compromised tissue.

 

By accurately quantifying tissue oxygen saturation and hemoglobin concentration and distribution, we provide an early warning system for complications due to compromised circulation, including diabetic foot ulcers.

An ounce of prevention is priceless

Powered by an advanced imaging technology known as spatial frequency domain imaging, Clarifi quantifies and displays 5 key biomarkers:*

 

  • Tissue oxygen saturation (StO2)
  • Oxyhemoglobin (HbO2)
  • Deoxyhemoglobin (HbR)
  • Papillary dermis hemoglobin (HbT1)
  • Reticular dermis hemoglobin (HbT2)

 

Tissue oxygen saturation is a necessary, but insufficient indicator of tissue health. Clarifi’s ability 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.

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 that “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.”

Clarifi is designed for use throughout the continuum of care

 

Clarifi is designed to help clinicians identify compromised circulation that indicates a patient may be at risk for an ulceration or infection. A fully integrated system that is easy to operate, Clarifi supports consistency in practice, enable early detection and intervention, potential to improve outcomes, and help reduce costs across the continuum of care.

 

The Clarifi Imaging System is easy and affordable for clinicians to integrate into their practice and supported by reimbursement (CPT code 0061U). Clarifi™ is a powerful new point-of-care imaging system designed to help clinicians identify pre-ulcerative circulatory compromise.

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.  Clarifi Imaging System is not licensed for sale outside the U.S.