IRVINE, Calif., Aug. 25 /PRNewswire/ -- Masimo(R), the inventor of Pulse CO-Oximetry(TM) and Read-Through Motion and Low Perfusion Pulse Oximetry, announced an important milestone for care of cyanotic infants and children with the FDA clearance of the Masimo SET LNOP(R) Blue sensor. Upon review of clinical data gathered from leading children's hospitals, the FDA has cleared the LNOP Blue Sensor for measuring the oxygen saturation of arterial blood (SpO2) in pediatric, infant and neonatal patients with congenital cardiac lesions with accuracy of 3% from 100% to 80% and accuracy of 4% from 80% to 60%. Due to the unique physiology and critical condition of these patients, accurate monitoring of SpO2 has not been possible. Prior to the introductionof Masimo SET LNOP Blue sensor, pulse oximeters' inaccuracies were as high as 15%(1) on cyanotic patients.
Peter Cox, MD, Clinical Director, Pediatric Intensive Care Unit, Hospital for Sick Children in Toronto, Canada stated, "We have tested this new Blue sensor for over 12 months on many cyanotic babies with oxygen saturations in the 60% to 80% range. We have compared the readings from the Masimo sensor to values obtained from the gold standard, invasive CO-Oximetry. This new sensor has remarkable precision and accurately tracks the arterial oxygen saturation to low levels. In the past, oximeters have been inaccurate in this range. We even had a case where the Blue sensor accurately tracked arterial saturation to the low 30% range. These cyanotic patients are very difficult to monitor and this new sensor helps us more accurately assess these patients' oxygenation status."
Anthony C. Chang, M.D., M.B.A., Director, Pediatric Cardiac Intensive Care Unit, Texas Children's Hospital added, "Masimo has really led the charge in developing technological advances that would accurately measure pulse oximetry in cyanotic heart disease patients. This advance enables the physicians and nurses taking care of cyanotic patients to deliver proactive critical care medicine."
The Masimo SET LNOP Blue Sensor is the first sensor designed specifically for cyanotic babies. The LNOP Blue sensor is the first and only sensor to receive accuracy claims for cyanotic infants and children. Cyanotic infants and children have long presented challenging conditions for reliable and accurate pulse oximetry, and Masimo's research team recognized years ago that the robust and sensitive capabilities of Masimo SET might represent a critical solution for this group. The LNOP "Blue" project was undertaken based on clinicians' request, patient need, and Masimo's patient focused philosophy.
Mike Petterson, RRT and Vice President of Clinical Research of Masimo, stated, "Several independent studies will soon be published on the clinical accuracy of the Masimo SET LNOP Blue sensor. These studies investigate the accuracy and precision of the Masimo SET LNOP Blue sensor in caring for cyanotic patients, where the correct amount of oxygenation could have a huge impact on the outcome of these cyanotic children. It's great to work for a quality company with great people who can make a difference in peoples' lives."
Maribeth Sayre, MD, Director of Medical Affairs of Masimo, stated: "Management of cyanotic infants and children has been difficult without an accurate measurement of oxygen saturation other than painful, expensive, and intermittent arterial blood gases. Now there is a reliable, accurate, non-invasive method of continuously assessing oxygen saturation changes associated with different treatments and varying clinical conditions. This could have a profound effect on the care and outcome of these often fragile patients. The Blue sensor is in keeping with Masimo's guiding principles which include: Do what is best for patient care."
About Masimo
Masimo, founded in 1989, is the inventor and leader of Signal Extraction Technology(R) for the noninvasive monitoring of vital signs. Masimo Signal Extraction(TM) Technology, or Masimo SET(R), represents the standard of care for pulse oximeters. With its worldwide introduction in 1998, Masimo SET overcame data dropouts, false alarms and inaccurate measurements due to patient motion, low perfusion and other challenging conditions. Over 100 clinical studies support the conclusion that Masimo SET is the most effective pulse oximeter in the world.
With the advent of Rainbow(TM) Technology, Masimo ushers in a new era for noninvasive monitoring, where patients at risk of respiratory and cardiac complications, carbon monoxide poisoning and other life threatening diseases can be safely, noninvasively and accurately monitored with Pulse CO-Oximetry(TM). Masimo is headquartered in Irvine, California. Additional information about Masimo and its products can be found at http://www.masimo.com.
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