Healthcare Industry News:  Pulse Oximetry 

Devices Monitoring Regulatory

 News Release - April 3, 2008

Masimo PVI(TM) Cleared for Market in Japan

PVI could help clinicians assess a patient's fluid responsiveness noninvasively, according to a new study published in 'Anesthesia & Analgesia'

IRVINE, Calif., April 3, 2008 (HSMN NewsFeed) -- Masimo, the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion Pulse Oximetry, today announced Japanese Ministry of Health, Labor and Welfare (MHLW) approval of its PVI measurement. PVI is an index automatically derived from the Masimo plethysmographic waveform, which has been demonstrated to noninvasively assess fluid responsiveness in mechanically ventilated patients and can help clinicians assess if a patient's cardiac function is compromised.

PVI may help clinicians and emergency professionals to determine if a patient is dehydrated or over-hydrated-enabling more accurate fluid administration decisions-all by simply referring to the numerical Masimo PVI value that is continuously displayed on Masimo Rainbow SET Pulse CO-Oximeters. With one noninvasive sensor, Masimo Rainbow SET technology delivers multiple physiologic measurements that previously required invasive blood tests, including total hemoglobin (SpHb(TM)) and oxygen content (SpOC(TM)) (both pending FDA and other regulatory clearances), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI(TM), oxyhemoglobin (SpO2), perfusion index and pulse rate.

During surgery and post-operatively, the immediate identification and rapid intervention of patients who are most likely to respond to fluid administration (fluid responders) can enable organ preservation, while recognizing patients unlikely to respond to fluid administration (fluid non-responders) can prevent pulmonary edema. Clinical studies have shown that current static methods for assessing fluid responsiveness, including clinical examination, arterial blood pressure, heart rate and central venous and pulmonary artery occlusion pressure, are poor predictors of fluid responsiveness. Also dynamic indices, such as respiratory variations in arterial pulse pressure, inferior vena cava diameter, superior vena cava diameter and stroke volume, present significant limitations, are invasive and often operator-dependent.

PVI is a dynamic new indicator of fluid responsiveness that does not require an invasive procedure or manual calculation, yet has been demonstrated to be sensitive to changes in preload and to be an accurate predictor of fluid responsiveness in mechanically ventilated patients.

In this month's Anesthesia and Analgesia Journal, a clinical study titled, "Does the Pleth Variability Index (PVI) Indicate the Respiratory-Induced Variation in the Plethysmogram and Arterial Pressure Waveforms?" headed by Dr. Maxime Cannesson from the Louis Pradel Hospital and the Claude Bernard Lyon University in Lyon, France, studied 25 patients under general anesthesia and mechanical ventilation and found a strong correlation between Masimo's PVI measurement and the manually measured Delta POP (r=0.92), with a sensitivity of 93% and a specificity of 97%. The researchers had previously shown a high correlation between Delta POP and fluid responsiveness. The recent study findings also confirmed that the relationship between PVI and Delta POP was still significant when performed in the Anti-Trendelenburg (r=0.94) and Trendelenberg (r=0.93) body positions, illustrating the responsiveness of PVI to the dynamic and changing fluid volume status. Dr. Cannesson et al. concluded that PVI has "potential clinical applications for noninvasive fluid responsiveness monitoring."

"PVI should provide clinicians with the most effective and efficient noninvasive method of continuously measuring their patient's fluid volume," stated Michael O'Reilly, MD, EVP of Medical Affairs at Masimo. "The addition of PVI in Masimo pulse oximeters now available in Japan should help clinicians in Japan add a level of certainty and immediacy toward balancing and managing intravascular fluid volumes and cardiac output both inside and outside of the operating room."

About Masimo

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, and with it 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 trustworthy SpO2 and pulse rate measurements even under the most difficult clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced Masimo Rainbow SET, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb(TM)) and oxygen content (SpOC(TM)) (both pending FDA and other regulatory clearances), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI(TM), in addition to oxyhemoglobin (SpO2), perfusion index and pulse rate, 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 may include forward-looking statements. These forward-looking statements are based on current expectations about future events affecting us and are subject to uncertainties and factors, all of which are difficult to predict and many of which are beyond our control, including: risks related to our assumption that PVI will prove to be an effective clinical indicator of patient hydration and the need for fluid loading, that the findings in the study referred to herein will be replicated in future studies, that approval of PVI by the Japanese MHLW will serve to materially increase Masimo product sales or revenues targets for 2008, and assumptions related to the development of products and technologies that may compete with PVI, as well as other factors discussed in the "Risk Factors" section of our annual report on Form 10-K for the year ended December 29, 2007, filed with the Securities and Exchange Commission on March 4, 2008. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements or the risk factors contained in our annual report on Form 10-K for the year ended December 29, 2007, whether as a result of new information, future events or otherwise, except as may be required under the federal securities laws.

(1) Does the Pleth Variability Index Indicate the Respiratory Induced Variation in the Plethysmogram and Arterial Pressure Waveforms? Maxime Cannesson, MD, Bertrand Delannoy, MD, Antoine Morand, MD, Pascal Rosamel, MD, Yassin Attof, MD, Olivier Bastien, MD, PhD, Jean-Jacques Lehot, MD, PhD. Department of Anesthesiology and Intensive Care, Louis Pradel Hospital and Claude Bernard Lyon University, Lyon, France. Anesthesia & Analgesia. Vol. 106. No. 4. April 2008.

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, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.


Source: Masimo

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