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T-Stat® is the first medical device to be labeled

by the FDA as "sensitive to ischemia"

 

T-Stat is the first device to be labeled by the FDA as “sensitive to Ischemia” and has been proven in multiple trials as an easy-to-use and reliable tool for assessing the adequacy of oxygen delivery to tissue. 

 

The T-Stat 303 provides a continuous, non-invasive and localized measurement, sensitive to regional and global ischemia. T-Stat reports a capillary-weighted oxygen saturation which is closely related to a local venous saturation measure (see "Contribution Of Capillary Venous And Arterial Blood for T-Stat˜).

 

T-Stat® represents the newest and most advanced generation 

of optical critical care devices.

In the 1980’s, pulse oximetry and near-infrared (NIRS) became available, Now, Spectros introduces the first critical care system based on visible light spectroscopy (VLS). Why visible light?

 

Visible light is sensitive to ischemia, unlike pulse oximetry

T-Stat® is proven sensitive to ischemic injury, as it happens.1

Visible light has tight range of normal, unlike Near-Infrared Spectroscopy (NIRS) 

T-Stat® makes patient management more effective because the narrow range of normal ensures that changes in a patient’s baseline are detected earlier.1,2 Why is visible light more accurate? Because visible light senses hemoglobin in tissue 100 times more strongly than infrared,3 substantially reducing noise and measurement error.

Visible light correlates with invasive Svo2, unlike skin or muscle-based systems 

T-Stat® is unlike other optical devices that measure skin or muscle saturation – as these measures do not correlate with vascular outcome.4


Compare T-Stat®

Device

Spectros
T-Stat®

Somanetics
Invos®

Hutchinson
InSpectra®

CAS Medical
Fore-Sight®

Device Type

√ Visible Light

Near-Infrared

Near-Infrared

Near-Infrared

Labeled for Ischemia Detection

√ Yes

√ Yes

No

No

Range of Normal

√ Tight (±3%)1

Wide (±9%)1,6

Wide (±9%)1,6

Wide (±9%)1,6

Changes Outcome?

√ Yes 5

√ Yes

No

No

Site Measured

√ Mucosal

Brain

Muscle

Brain

Range of Probes?

√ Yes

No

No

No

 

 

The T-Stat® Tissue Oximeter measurements differ from conventional pulse oximetry in several important ways:

 

Capillary-weighted 

Hemoglobin oxygen saturation of blood in the microvascular tissue space, is typically lower than pulse oximetry saturation (SpO2%) and arterial saturation (SaO2%). Whereas pulse oximetry measures arterial saturation, tissue oxygenation is capillary-weighted, and estimates the hemoglobin oxygen saturation at the site of tissue oxygen extraction. Tissue optical saturation is thus responsive to changes in oxygenation of the tissue itself, whether caused by changes in arterial oxygenation (hypoxemia) or by changes in blood flow (reduced-flow or no-flow ischemia).

 

Nonpulsatile

Unlike pulse oximetry, a pulse is not required for the measurement to be made. Therefore, the T-Stat® Tissue Oximeter continues to measure during low-perfusion, hypotension, or asystole.

 

Normal Values Differ 

Hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) typically runs much closer to venous saturation (SvO2%) than to arterial saturation (SaO2%). Tissue oxygen saturation StO2% for some tissues has been established.  While reference ranges for human use have not been recognized in health and disease, measured and published values of StO2% for many tissues are typically 71% +/- 3%, or a 95% confidence interval of 65%  - 77%.
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