Spectros

Real-Time Tissue Perfusion Monitors

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

"sensitive to ischemia"

 

T-Stat is the first device to be labeled 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 VLS Tissue Oximeter 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 VLS 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).
  • Sensors 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.