SOURCE: Masimo

Masimo

January 23, 2014 08:00 ET

Masimo Announces CE Marking of O3™ Regional Oximetry

Study Presented at Society of Technology in Anesthesia Annual Meeting Demonstrates 4.0% Absolute Accuracy and 2.1% Trend Accuracy

IRVINE, CA--(Marketwired - Jan 23, 2014) - Masimo (NASDAQ: MASI) announced today the CE Marking of O3™ regional oximetry for the Root™ patient monitoring and connectivity platform. O3 regional oximetry is a new technology developed by Masimo and uses near-infrared spectroscopy (NIRS) in a Masimo Open Connect (MOC-9™) module with up to two sensors per MOC-9 module. Each sensor contains four light-emitting diodes (LEDs) and two detectors to continuously and simultaneously measure both tissue oxygen saturation (rSO2) and arterial blood oxygenation (SpO2).  Root allows either one or two O3 MOC-9 modules to be connected, enabling monitoring with as few as one and as many as four sensors.

Regional oximetry, also referred to as tissue oximetry and cerebral oximetry, enables the continuous assessment of the oxygenation of the tissue beneath the sensor. O3 helps clinicians detect regional hypoxemia that pulse oximetry alone can miss. In addition, the onboard pulse oximetry capability in O3 sensors can automate the differential analysis of regional to central oxygen saturation. O3 monitoring is as simple as applying O3 regional oximetry sensors to the forehead and connecting the O3 MOC-9 module to any Root through one of its three MOC-9 ports. Root offers multiple unprecedented, high-impact innovations including:

  • Radical-7® with Masimo's breakthrough rainbow® and SET® measurements
  • Instantly interpretable, high visibility, intuitive-navigation touchscreen display
  • MOC-9 flexible measurement expansion with SedLine® EEG brain function monitoring and Phasein™ capnography, in addition to O3 regional oximetry and future measurements
  • Iris™ for built-in connectivity gateway for standalone devices such as IV pumps, ventilators, hospital beds, and other patient monitors
  • MyView™ for automatic display of parameters, waveforms, and viewing configuration based on the clinician's preference and presence

In an abstract presented at the Society for Technology in Anesthesia 2014 Annual Meeting in Orlando, Fla., Dr. Daniel Redford from the University of Arizona evaluated cerebral oxygen saturation on 23 subjects and 202 paired measurements of rSO2 from O3 regional oximetry and reference arterial and venous blood samples (SavO2).1 Reference blood samples were taken from both an arterial cannula placed in the radial artery and a catheter placed in the internal jugular bulb vein, obtained at baseline and after a series of increasingly hypoxic states. O3 regional oximetry had an absolute accuracy of 4.0% and trend accuracy of 2.1%. 

"Masimo O3 regional oximetry will have the unique ability to measure both rSO2 and Masimo SET® SpO2 pulse oximetry simultaneously from the same forehead sensor," said Dr. Michael Ramsay, M.D., Chief of the Department of Anesthesiology and Pain Management at Baylor University Medical Center in Dallas. "This may provide the anesthesiologist or perfusionist for the first time with a differential analysis of regional to central oxygen saturation monitoring that could help the clinician in maintaining brain oxygenation and safe cerebral perfusion during cardiac procedures." 

O3 regional oximetry is currently intended for use in subjects larger than 40 kg (88 lbs) and has not yet received FDA 510(k) clearance. 

Joe Kiani, CEO and Founder of Masimo, said, "O3 regional oximetry delivers again on Masimo's mission to improve patient outcomes and reduce cost of care by taking noninvasive monitoring to new sites and applications. We look forward to partnering with key hospitals around the world to demonstrate O3's technical and clinical advantages."

1 Redford D, Paidy S, Kashif F, STA 2014; 46 (abstract); to download abstract, click here

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care -- helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to help clinicians detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow ® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow® Acoustic Monitoring, the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET® and Masimo rainbow® technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care ... by Taking Noninvasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.

Forward-Looking Statements
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 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 O3 Regional Oximetry provides clinically acceptable absolute and trend accuracy, risks related to our belief that O3 Regional Oximetry simultaneously supports critical regional cerebral oxygen saturation and blood oxygenation, and that it helps ensure safe, adequate cerebral perfusion of the patient's brain, as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.

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