Masimo Corporation Obtains CE Mark for SEDLine, Launches EEG-Based Brain Function Monitors in European Market
8/24/2011 7:02:07 AM
IRVINE, Calif., Aug. 24, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that it has received CE Mark for its SEDLine brain function monitor expanding access to and availability of SEDLine's advanced neuromonitoring technology to hospitals and clinicians across Europe. The only brain function monitor with four separate EEG channels in a single integrated algorithm SEDLine represents a critical advancement for the practice of anesthesia in Europe more complete data for a more complete picture of brain function and sedation.
SEDLine expands the scope of real-time data and improves the management of an anesthetic case by enabling more individualized titration. Four channels of high-quality EEG data provide information about both sides of the brain to facilitate immediate detection of asymmetrical activity and yields a single sophisticated algorithm to give accurate, reliable information about a patient's response to anesthesia. Masimo's SEDLine Patient State Index (PSI), a calculated measure of brain activity that reflects the patient's current level of sedation/anesthesia(1), provides additional data to enhance anesthetic control and facilitate rapid assessment. With demonstrated reliability under challenging clinical conditions and superior resistance to cautery(2), SEDLine offers a cost-effective solution for brain function monitoring that helps clinicians achieve targeted sedation throughout all phases of anesthesia in the OR and ICU.
According to Michael Ramsay, M.D., Chief of Anesthesiology and Pain Management & President of the Research Institute at Baylor University Medical Center in Dallas, Texas, "For many of the liver transplants and cardiac anesthesia cases I participate in, SEDLine provides me with real-time access to more comprehensive brain activity data, which is especially critical when a surgical patient's hemodynamic parameters are rapidly changing. Because of SEDLine's unique four separate EEG channels in a single integrated algorithm enabling greater control and sedation management I believe it will also complement the use of Target Control Infusion narcotic based anesthesia, which is a widely used technique in Europe."
The introduction of EEG-based monitoring systems such as SEDLine to provide guided titration has been shown to reduce the amount of anesthetic used and decrease recovery time when used as an adjunct to current standard clinical practice.(3-4) In fact, these studies show that SEDLine PSI facilitated more individualized titration of anesthesia that led to patients receiving significantly less anesthetic and recovering an average of 67% faster ultimately enabling faster OR to PACU throughput with patients meeting discharge eligibility 19% faster than non-SEDLine-monitored patients.
Masimo Founder and CEO, Joe Kiani, stated: "The risks associated with the expanded use of short-acting anesthetic drugs like Propofol, where patients go in and out of the sedation state very quickly, makes it increasingly important for anesthesiologists to maintain tighter control. Masimo's SEDLine PSI and our popular 4-channel waveforms help anesthesiologists keep their patients where they want them to be improving sedation control and the management of anesthetized patients."
SEDLine is currently used by top U.S. hospitals, including Baylor Medical Center in Dallas, TX; Massachusetts General Hospital in Boston, MA; Stanford University Medical Center in Palo Alto, CA; New York Columbia Presbyterian Hospital in NYC; Loma Linda University Medical Center in Loma Linda, CA.
(1) Prichep LS, Gugino LD, John ER, et al. The Patient State Index as an indicator of the level of hypnosis under general anesthesia. Br J Anaesth. 2004,92:393-399. Available online at http://bja.oxfordjournals.org/cgi/content/full/92/3/393.
(2) White PF, Tang J, Ma H, Wender RH, Sloninsky A, Kariger R . Is the Patient State Analyzer with the PSArray2 a cost-effective alternative to the Bispectral Index Monitor during the perioperative period? Anesth Analg. 2004;99:1429-1435.
(3) Drover DR, Lemmens HJ, Pierce ET, et al. Patient State Index: titration of delivery and recovery from propofol, alfentanil, and nitrous oxide anesthesia. Anesthesiology. 2002;97:82-89.
(4) Cassingham SF, Hebert T, Lemaire R, Cook R, McPherson PK. The Physiometrix PSA 4000 decreases propofol usage and hastens discharge in gynecological day surgery procedures. Anesthesiology. 2002;96:A5.
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 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 rainbow SET® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, 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). 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 noninvasive and continuous monitoring of acoustic respiration rate (RRa). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also 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.
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 SEDLine facilitates more individualized titration of anesthesia that leads to patients receiving significantly less anesthetic and recovering faster, risks related to our assumptions of the repeatability of clinical results obtained, and risks related to our assumptions that SEDLINE will facilitate immediate detection of asymmetrical activity in all patients, 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.
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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.
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