Data to be presented at American Society of Anesthesiologists Annual
Meeting as Masimo showcases world's first-and-only noninvasive and continuous hemoglobin (SpHb) and Oxygen Content (SpOC) monitor with live
IRVINE, Calif., Oct. 17 /PRNewswire-FirstCall/ -- Masimo, the inventor of Pulse CO-Oximetry(TM) and Measure-Through-Motion-and-Low-Perfusion pulse oximetry, announced today that five new independent and objective studies demonstrating Masimo PVI to be highly predictive of patient fluid status will be presented at the American Society of Anesthesiology (ASA) Annual Meeting in Orlando, Fla., October 19-21, 2008.
Fluid administration is critical to optimizing patient status and enabling end organ preservation, but traditional methods to guide fluid administration are invasive and often fail to predict fluid responsiveness. PVI has been shown to predict fluid responsiveness in mechanically ventilated patients under general anesthesia during surgery, and may help clinicians optimize fluid administration and improve patient outcomes.(2-4)
Also at ASA for the first time, Masimo will be showcasing live demonstrations of the first-ever noninvasive and continuous hemoglobin (SpHb) and Oxygen Content (SpOC) monitor. SpHb provides instantaneous hemoglobin measurements that may facilitate faster, easier, safer, and better clinical decisions by allowing clinicians to more quickly detect chronic or acute anemia, identify occult bleeding earlier, and more effectively manage blood transfusions. While oxygen saturation (SpO2) and hemoglobin are considered critical parameters for patient management, neither parameter by itself can indicate the actual amount of oxygen in the blood. However, now with Masimo Rainbow SET Pulse CO-Oximetry, SpHb and SpO2 can be used together to provide clinicians with the first-and-only technology for real-time and noninvasive oxygen content (SpOC(TM)) monitoring, providing a more complete picture of oxygenation status and potentially allowing earlier indication of when a patient crosses the threshold into a critical oxygen deficit.
The following studies will be presented at the ASA Annual Meeting:
Impact of PEEP on Perfusion Index and Plethysmographic Variability Index(1)-A1068, Presented: October 20, 2008, 2:00-4:30 p.m., Room Hall E2-Area M
Ability of Pleth Variability Index to Non Invasively Predict the Hemodynamic Effects of PEEP(2)-A1608, Presented: October 22, 2008, 8:00-9:30 a.m., Room 230C
Ability of Pleth Variability Index to Detect Preload Changes in Orthotopic Liver Transplant Patients(3)-A1605, Presented: October 22, 2008, 8:00-9:30 a.m., Room 230C
Pleth Variability Index: A Noninvasive Device for Fluid Responsiveness Assessment during Anesthesia(4)-A1604, Presented: October 22, 2008, 8:00-9:30 a.m., Room 230C
Impact of Lower Extremity Nerve Blockage on Oximeter Perfusion Index & Pleth Variability Index(5)-A1603, Presented: October 22, 2008, 8:00-9:30 a.m., Room 230C
Michael O'Reilly, MD, EVP of Medical Affairs at Masimo, stated; "These studies add to the evidence showing that PVI can provide clinicians with an effective and efficient noninvasive method of continuously measuring their patient's fluid volume. This should enable more accurate fluid administration decisions -- allowing clinicians to add a level of certainty and immediacy toward managing intravascular fluid volumes and cardiac output both inside and outside of the operating room."
PVI is available as part of Masimo Rainbow SET(R) Pulse CO-Oximetry(TM) -- the first-and-only technology platform to noninvasively measure blood constituents and fluid responsiveness that previously required invasive procedures, including: noninvasive & continuous total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)) and Pleth Variability Index (PVI), in addition to the 'gold standard' measure-through-motion-and-low-perfusion performance of Masimo SET(R) Oxygen Saturation (SpO2), Pulse Rate (PR) and Perfusion Index (PI).
Masimo (Nasdaq: MASI) develops innovative 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 demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and PVI(TM), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. Founded in 1989, Masimo has the mission of "Improving Patient Outcomes 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 http://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 belief that Masimo PVI and total hemoglobin (SpHb(TM)) will deliver a sufficient level of clinical improvement over alternative fluid assessment and hemoglobin measurement capabilities to allow for rapid adoption of the technology, risks related to our assumptions regarding the repeatability of clinical results, and risks related to our assumptions regarding timing or commercial availability of SpHb, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2008, filed with the Securities and Exchange Commission ("SEC") on August 5, 2008, which may be obtained for free at the SEC's website at http://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 forward-looking statements or the "Risk Factors" contained in our Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2008, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
(1) Impact of PEEP on Perfusion Index and Plethysmographic Variability Index. Nitin K. Shah, M.D., Darin V. Allred, M.D., Laverne Estanol, M.S., Brian Fine, B.S., Gandhi Vipal, B.S. Anesthesiology, Long Beach VAHS, Long Beach, California.
(2) Ability of Pleth Variability Index to Non Invasively Predict the Hemodynamic Effects of PEEP. Olivier Desebbe, M.D., Cecile Boucau, R.D., Pascal Rosamel, M.D., Jean-Jacques Lehot, M.D., Ph.D., Maxime Cannesson, M.D. Department of Anesthesiology, Louis Pradel Hospital, Lyon-Bron, France.
(3) Ability of Pleth Variability Index to Detect Preload Changes in Orthotopic Liver Transplant Patients. Christopher Wray, M.D., Jack Buckley, M.D., Derek Kwan, B.S., Tayeba Maktabi, Aman Mahajan, M.D., Ph.D. Anestheiology, UCLA David Geffen School of Medicine, Los Angeles, California.
(4) Pleth Variability Index: A Noninvasive Device for Fluid Responsiveness Assessment during Anesthesia. Olivier Desebbe, M.D., Bertrand Delannoy, R.A., Jean-Jacques Lehot, M.D., Ph.D., Olivier Bastien, M.D., Ph.D., Maxime Cannesson, M.D. Department of Anesthesiology, Louis Pradel Hospital, Lyon-Bron, France.
(5) Impact of Lower Extremity Nerve Blockage on Oximeter Perfusion
Index & Pleth Variability Index. Darin V. Allred, M.D., Nitin K. Shah,
M.D., Laverne Estanol, M.S. Anesthesiology, University of California at
Irvine, Orange, California.
Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57, Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
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