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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 Prescribing Information

Indications for Use:

The Spectros T-Stat 303 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states.

The prospective clinical value of measurements made with the T-Stat Oximeter has not been demonstrated in disease states. The T-Stat Oximeter should not be used as the sole basis for diagnosis or therapy.

Clinical Studies:

In peer-reviewed studies of T-Stat:

T-Stat® was sensitive to reduced-flow and no-flow ischemic states (p<0.001) [1,2].
T-Stat provided readings in low-flow and no-flow ischemic states [1,2].
T-Stat tissue oxygenation (StO2%) determined using VLS was unbiased in comparison to StO2% determined using NIRS predicates (StO2% Bias = –1%±5%, p=N.S.), but VLS demonstrated significantly tighter ranges of normal (VLS normal range 62-75% vs. NIRS reported at 48-88%, p<0.001) [1].

Precautions

T-Stat measures locally, and may not reflect changes in oxygenation that occur in regions outside of that monitored by the T-Stat catheter.
T-Stat used alone at a single site cannot differentiate between local and global ischemic conditions.
Use of T-Stat during high-output shock states such as sepsis has not been evaluated. During these conditions, central venous saturation may be normal or elevated, and the ability of T-Stat to detect tissue hypoxia is unknown.
Normal T-Stat® values liver and the small intestine have not yet been established, as these readings are affected by organ pigments and surface bile (respectively).
Catheters are supplied sterile for single use. Do not reuse.

References

[1] Anesthesiology. 2004 Jun;100(6):1469-75

[2] Gastrointest Endosc Clin N Am. 2004 Jul;14(3):539-53, ix-x.

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