New study presented at the 2006 Respiratory Care Congress
concludes that Masimo Blue sensor is only sensor to demonstrate
acceptable accuracy on this low saturation patient population
Irvine,
California December 13, 2006 - Masimo,
the inventor of Pulse CO-Oximetry and Read-Through Motion and Low
Perfusion pulse oximetry, reported that a new independent study
presented today at the 2006 American Association for Respiratory Care
(AARC) Congress in Las Vegas, concluded that the Masimo Blue sensor is
the most accurate technology for monitoring babies with cyanotic
congenital heart disease. This patient population has represented
a difficult challenge for pulse oximeters due to the patients' unique
physiology and the need to keep their saturation at a low level.
The researchers compared Masimo SET Radical using the Masimo Blue
sensor with the Nellcor N600 LoSat technology using a Max-I sensor and
concluded that only the Masimo Blue sensor demonstrated acceptable
accuracy on this patient population.
The study entitled, "New Pulse Oximetry Sensors with Low Saturation
Accuracy Claims - A Clinical Evaluation" was conducted at The Toronto
Hospital for Sick Children by a research team headed by Dr. Peter
Cox. The researchers indicated that, despite many advances in
pulse oximetry technology, accuracy on patients with low saturations
was still a problem. Dr. Cox's specific interest was the
performance of pulse oximeters on babies with cyanotic congenital
cardiac lesions (CCCL) which typically are kept at very low blood
oxygen levels to maintain a balance of blood flow to the lungs and the
body. He explained that careful maintenance of oxygen saturation
levels on these babies is critical to their survival. The study
was prompted by the fact that two pulse oximetry manufacturers have
recently introduced products specifically suited for this patient
population. Masimo introduced the Blue sensor in 2005 and Nellcor
introduced their LoSat technology in 2006.
Dr. Cox and his team compared the Masimo Blue sensor to a Nellcor
N600 with LoSat technology on babies with CCCL. The researchers found a
statistically significant difference between the Masimo and Nellcor
pulse oximeters and concluded, "Despite advances in technology, only
the new Masimo Blue sensor demonstrates acceptable accuracy as
demonstrated by a smaller bias, precision and Arms."
About Masimo
Masimo develops innovative
monitoring technologies that significantly improve patient care-helping
solve "unsolvable" problems. In 1995, the company debuted Read-Through
Motion and Low Perfusion pulse oximetry, known as SET, and with it
virtually eliminated false alarms and increased pulse oximetry's
ability to detect life-threatening events. More than 100 independent
clinical studies have confirmed that Masimo SET technology allows
clinicians to accurately monitor blood oxygen saturation in critical
care situations-establishing the technology as the "gold standard"
pulse oximetry and substantially contributing to improved patient
outcomes. In 2005 Masimo introduced Masimo Rainbow SET Pulse
CO-Oximetry, which, for the first time, noninvasively monitors the
level of carbon monoxide and methemoglobin in the blood, allowing early
detection and treatment of potentially life-threatening conditions.
Masimo, founded in 1989, 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.
Contact:
Tom McCall
Masimo Corporation
949-297-7075
Masimo, SET, Signal Extraction Technology,
Radical, Radical-7, Rad57, APOD, and Improving and Reducing Cost of
Care by Taking Noninvasive Monitoring to New Sites and Applications are
registered trademarks of Masimo Corp. Rainbow, SpCO, SpMet and Pulse
CO-Oximeter are trademarks of Masimo Corp.
New Pulse Oximetry Sensors with Low Saturation Accuracy Claims - A Clinical Evaluation. Cox PN. Hospital for Sick
Children, Toronto, Canada, 2006.