NEUCHATEL, SWITZERLAND -- (Marketwired) -- 06/05/15 --
Masimo (NASDAQ: MASI) announced today a new clinical study presented at the European Society of Anaesthesiology'sEuroanaesthesia 2015 Annual Congress in Berlin, Germany. The study evaluated Masimo's parameters of noninvasive, continuous haemoglobin, SpHb®, and fluid responsiveness, PVI®, with patients in hospital settings.
SpHb and PVI*
Dr. Sebastien Ponsonnard and researchers at CHU Limoges, Department of Anaesthesiology & Intensive Care, in Limoges, France, evaluated the impact on mortality and morbidity in patients who underwent general anaesthesia at the hospital after the introduction of Masimo SpHb continuous haemoglobin measurement and response to fluid loading by PVI.1
Operating rooms and ICUs were equipped with Masimo Radical-7 Pulse CO-Oximeter® monitors. Over a six-month period (Feb. 6-Aug. 7, 2014), patients receiving general anaesthesia were monitored noninvasively.
At one month, mortality decreased in 2014 (vs. 84/5123 = 1.64% vs. 121/5478 = 2.2%, P = 0.024). In-hospital mortality was not different between the two years. Death in cardiothoracic surgery was slightly lower (P = 0.07).
Researchers concluded: "These results suggest that by using a non-invasive monitor, measuring SpHb and fluid loading responsiveness is possible on a large scale. The observed reduction of mortality agrees with multi-centric randomized studies using more invasive monitoring systems2 and support the large use of such a device."
* For CE Marking:
- The Radical-7 is intended for the continuous and noninvasive monitoring of SpO2, SpCO, SpMet and SpHb.
- The Radical-7 with PVI has been clinically evaluated for fluid responsiveness measurements.
For the US market:
- The Radical-7 is indicated for the continuous and noninvasive monitoring of SpO2, SpCO, SpMet and SpHb.
- The Radical-7 with PVI is a measure of dynamic changes in the perfusion index (PI) that occur during the respiratory cycle. The PVI calculation is accomplished by measuring changes in PI over a time interval where one or more complete respiratory cycles have occurred. PVI is displayed as a percent (0-100%). PVI may show changes that reflect physiologic factors such as vascular tone, circulating blood volume and intrathoracic pressure excursions. The utility of PVI is unknown at this time and requires further clinical studies. Technical factors that may affect PVI include probe malposition and patient motion.
1. Ponsonnard S, Yonnet S, Marin B, Cros J, Ben Miled S, Nathan N. "Continuous Hb and plethysmography variability index (PVI) monitoring is associated to a decreased mortality at the scale of a whole hospital." Proceedings of the European Society of Anaesthesiology's Euroanaesthesia 2015 Annual Congress, May 30-June 2, Berlin, Germany, 16AP3-2, Room A1 - Poster Abstract Presentation Session, e-Board 8
2. Hamilton et al. AnesthAnalg. 2011
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 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 SET® 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 Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com. @masimoinnovates
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 of the repeatability of clinical results obtained; 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 are trademarks or registered trademarks of Masimo.