Spectros has reported that the T-Stat Tissue Oximeter sensor line will be expanded to include the new Continuum Cerebral Sensor line upon receipt of FDA marketing approval anticipated in 2010.
The company claims that T-Stat continuum sensor relies on broadband, multispectral visible and infrared illumination in order to obtain market-leading absolute tissue oximetry noninvasively in tissues such as the brain, gut, and breast.
An FDA review process for marketing approval is underway, and Spectros anticipates marketing the Continuum sensor upon receipt of FDA marketing approval. Clinical studies of the Continuum sensor were initiated in 2008, with additional studies planned and in progress.
The T-Stat VLS Tissue Oximeter was approved by FDA as sensitive to ischemia. It is the commercially-available tissue oximeter that utilizes multispectral visible light spectroscopy (VLS) technology.
The non-invasive T-Stat VLS system is used clinically to provide a continuous and real-time absolute value, utilizing 260 wavelengths, over the competing NIRS oximeter product lines that only use 2-4, said the company.
Elizabeth van Thillo, director of marketing, said: “The expansion of the T-Stat product line to include cerebral sensors furthers the already market-leading accuracy and success of the T-Stat into cerebral oximetry monitoring.
“We currently have additional clinical studies at multiple clinical centers and will continue to demonstrate the efficacy of the T-Stat with the Continuum sensor line to reduce hospitalization costs and improve patient outcome in high-risk populations with early diagnosis.”