Hutchinson Technology Receives FDA Clearance For InSpectra StO2 Tissue Oxygenation Monitor
Hutchinson, MN - Hutchinson Technology Incorporated announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin marketing its InSpectra StO2 Tissue Oxygenation Monitor. The patented device uses near infrared technology to noninvasively provide an absolute measurement of local tissue oxygen saturation (StO2). The InSpectra StO2 System is the only such device designed for clinical use in the trauma and emergency medicine settings.
Hutchinson Technology received FDA clearance in 2002 to market its first-generation tissue spectrometer, which was primarily used as a research device. "This second-generation InSpectra StO2 Tissue Oxygenation Monitor is designed for clinical use in the trauma care market where there is a need to directly monitor the compromised circulation associated with hemorrhagic shock," said Christina Temperante, president of Hutchinson Technology's BioMeasurement Division. "Our device provides immediate, direct and continuous monitoring of local tissue oxygen saturation, filling a critical, widely recognized information gap in medical monitoring of trauma patients."
Temperante said the company will formally introduce the device to the market at the 2006 annual meeting of the American Association for the Surgery of Trauma, which will be held September 28 - 30 in New Orleans. At this meeting, the results of the company's multi-site, prospective clinical trial on hemorrhagic shock monitoring will be presented. The clinical trial was initiated in October 2004 to determine the role tissue oxygen saturation monitoring can play in hemorrhagic shock and resuscitation. Seven major U.S. trauma centers participated, enrolling a total of 383 patients. "The size and scope of the study underscores our commitment to demonstrate the clinical utility and economic value of the product we're bringing to the market," said Temperante.
The InSpectra StO2 System consists of a monitor, optical cable and single-use patient interface. The device is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle, or when there is a suspicion of compromised circulation. "Because tissue oxygenation is fundamental to health, we continue to work with independent clinical researchers in both the U.S. and Europe to explore the utility of measuring tissue oxygen saturation in several other critical care applications," said Temperante.
SOURCE: Hutchinson Technology