Masimo obtained the CE mark to SEDLine.

-Masimo obtains the CE mark for SEDLine and launches the brain function controls based on EEG in the European market

-European availability expands access to the platform of function of the brain critical care

Irvine, California, August 24, 2011- / PRNewswire / – Masimo (NASDAQ: MASI) today announced that it has received the CE mark for its control of the function of the brain SEDLine – expanding the access and availability of the technology of advanced SEDLine neurocontrol to hospitals and clinics in Europe. Sole control of the function of the brain with four EEG channels separated into an integrated simple algorithm SEDLine represents a critical step forward for the practice of anesthesia in Europe – more complete data for a more complete picture of brain function and the sedation.

SEDLine broadens the scope of the data in real time and improves the management of a numbing case allowing more individualized titración.

Four channels of high quality EEG data provide information on both sides of the brain to facilitate the immediate detection of asymmetric activity and results of a sophisticated simple algorithm to give accurate and reliable information on the response of the patient to the anesthesia. SEDLine Patient State Index (PSI (TM)) of Masimo, a calculated measure of the activity of the brain that reflects the current level of sedation/anesthesia (1) of the patient, offers additional data to improve the anesthetic monitoring and facilitate a quick assessment. With the reliability proven in difficult clinical conditions and superior resistance to Cauterization (2), SEDLine offers an economical solution for the control of brain function that helps doctors get objective sedation at all stages of anaesthesia – go and ICU.

According to Michael Ramsay, M.D., head of Anesthesiology and pain control and director general of the Research Institute at Baylor University Medical Center in Dallas, Texas, “for many of liver transplants and cases of cardiac anesthesia in which I participated, SEDLine gives me access in real time to larger brain activity data”which is especially critical when the surgical patient hemodynamic parameters are changing rapidly.

“Due to their four-channel EEG separated only from SEDLine in a single, integrated algorithm, which allow greater control and administration of sedation – I believe that it will also complement the use of anesthesia based on control of destiny of narcotic infusion, which is a technique widely used in Europe.”

The introduction of control systems based on EEG as SEDLine to provide guided titración has shown to reduce the amount of used anesthesia and reducing recovery time when used as a complement to the current routine clinical practice.(3-4) In fact, these studies show SEDLine PSI provided more titración individualized anesthesia led patients to receive much less anesthesia and recovery in an average of 67% faster – ultimately allowing faster performance OR a PACU patients fulfilling an eligibility of 19% faster than downloading the patients not controlled by SEDLine.

Joe Kiani, founder and Managing Director of Masimo, stated: “the risks associated with the expansion of the use of quick-acting drugs as anesthetic such as Propofol, where patients entering and leaving the State of sedation very rapidly, makes it increasingly important for anesthesiologists keep tighter control.” “SEDLine PSI of Masimo and our popular wave of 4 channels help Anesthesiologists to keep their patients where they want to be – to improve control and management of sedation of patients anestesiados.”

SEDLine is currently used in major hospitals in the United States.UU., including Baylor Medical Center in Dallas, TX; Massachusetts General Hospital in Boston, MA; Stanford University Medical Center in Palo Alto, CAM New York Columbia Presbyterian Hospital in NYC; Loma Linda University Medical Center in Loma Linda, CA.

About Masimo

Masimo (NASDAQ: MASI) is the global leader in innovative technologies of control non-invasive that significantly improve the patient care – helping to solving “unsolvable” problems. In 1995, the company introduced the Measure-Through Motion and Low many pulse oximetry, known as Masimo SET r, which virtually eliminates false alarms and improves the ability of pulse oximetry to detect life-threatening events. More than 100 independent and objective studies demonstrate that Masimo SET provides the most reliable measurements of SpO2 pulse rate even in the most demanding clinical conditions, such as the movement of the patient and low peripheral perfusion. In 2005, Masimo introduced the technology rainbow SET r Pulse Oximetry-CO Tm, allowing control noninvasive and continuous component of the blood that previously required invasive procedures, including total hemoglobin (SpHb (R), oxygen (SpOC (TM), carboxyhemoglobin (SpCO r), metemoglobina (SpMet (R)), and content Pleth Variability Index (PVI (R)), as well as SpO2, frequency of the pulse, and index of perfusion (PI). In 2008, Masimo introduced Patient SafetyNet Tm, a remote control and reporting system clinical wireless designed to help hospitals prevent deaths and injuries preventable associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring (TM), the first control noninvasive and continuous rate of acoustic breathing (RRa Tm). The technological platform of Masimo SET rainbow offers a breakthrough in the patient safety, helping doctors to detect life-threatening diseases and help guide treatment options. In 2010, Masimo acquired SEDLine r, a pioneer in the development of innovative technology and brain function monitoring devices. Technologies SET Masimo and Masimo rainbow SET can be found in more than 100 controls multi-parameter of patients from more than 50 manufacturers of medical devices in the world. Founded in 1989, Masimo has the Mission of “Improving Patient Outcome and Reducing Cost of Care… by Taking Berenson Monitoring to New Sites and Applications r.

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References:

(1) Prichep LS, Gugino LD, John ER, et to the. The Patient State Index as an indicator of the level of hypnosis under general anesthesia. BR J Anaesth. 2004, 92: 393-399 Available here

(2) White PF, Tang J, Ma H, Wender RH, Sloninsky, 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 Rd, Lemmens HJ, Pierce ET, et to the. 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.