Masimo Announces CE Marking for Pediatric O3™ Regional Oximetry
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O3 regional oximetry uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. Early detection and correction of imbalances in oxygen delivery to the brain and vital organs are important tools in helping patients avoid postoperative morbidity and adverse outcomes.1 With the release of the O3 pediatric sensor, O3 regional oximetry monitoring of rSO2 is now available to pediatric patients weighing less than 40 kg (88 lbs).
“O3 regional oximetry provides access to valuable data about cerebral
oxygen saturation, and studies have shown that the risks of cerebral
desaturations include neurological injury2,3, increased
length of hospital stays3, increased time on mechanical
ventilation4, and other adverse outcomes5,” said
Masimo O3 regional oximetry and SedLine® brain function
monitoring are both available on a single platform,
O3 regional oximetry for use with adults weighing 40 kg (88 lbs) or
greater has received
@MasimoInnovates | #Masimo
- Booth, Dukatz, Ausman, and Wider. “Cerebral and somatic venous oximetry in adults and infants.” Surg. Neurol Int. 2010; 1: 75.
Colak Z, Borojevic M, Bogovic A, Ivancan V, Biocina B, Majeric-Kogler
V. Influence of intraoperative cerebral oximetry monitoring on
neurocognitive function after coronary artery bypass surgery: a
randomized, prospective study. European journal of cardio-thoracic
surgery : official journal of the
European Association for Cardio-thoracic Surgery. 2015 Mar;47(3):447-54.
- Slater JP, Guarino T, Stack J, et al. Cerebral Oxygen Desaturation Predicts Cognitive decline and longer hospital stay after cardiac surgery. Ann Thorac Surg 2009;87:36-45.
- Goldman S, Sutter F, Ferdinand F, Trace C. Optimizing intraoperative cerebral oxygen delivery using noninvasive cerebral oximetry decreases the incidence of stroke for cardiac surgical patients. The heart surgery forum. 2004;7(5):E376-381.
- Deschamps A, Lambert J, Couture P, et al. Reversal of decreases in cerebral saturation in high-risk cardiac surgery. Journal of cardiothoracic and vascular anesthesia. 2013;27(6):1260-1266.
- Masimo data on file.
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
This press release includes forward-looking statements as defined in
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, in connection with the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include, among others, statements regarding the potential
effectiveness of Masimo O3™ Regional Oximetry. These forward-looking
statements are based on current expectations about future events
affecting us and are subject to risks and uncertainties, all of which
are difficult to predict and many of which are beyond our control and
could cause our actual results to differ materially and adversely from
those expressed in our forward-looking statements as a result of various
risk factors, including, but not limited to: risks related to our
assumptions regarding the repeatability of clinical results; risks
related to our belief that Masimo's unique noninvasive measurement
technologies, including Masimo O3™ Regional Oximetry, contribute to
positive clinical outcomes and patient safety; risks related to our
belief that Masimo noninvasive medical breakthroughs provide
cost-effective solutions with comparable accuracy and unique advantages,
including: immediate and continuous results that enable earlier
treatment without causing invasive trauma in all patients and in every
clinical situation; as well as other factors discussed in the "Risk
Factors" section of our most recent reports filed with the
Irene Paigah, 858-859-7001