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 /PRNewswire-FirstCall/ -- 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(R)),
methemoglobin (SpMet(R)), 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(R)), methemoglobin (SpMet(R)), 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
CONTACT: Dana Banks of Masimo Corporation, +1-949-297-7348
Web site: http://www.masimo.com