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Masimo Radical-7 Bedside Monitor Receives FDA Clearance

October 6, 2006

The company's Rainbow technology enables the system to continuously and noninvasively monitor carboxyhemoglobin, methemoglobin, and oxyhemoglobin saturation.


IRVINE, CA /PRNewswire/ -- Masimo announced it has received FDA clearance for Masimo Radical-7—the "first" bedside monitor to feature the award winning Rainbow technology—which will be introduced at the upcoming annual meeting of the American Association of Anesthesiologists, October 14–18, in Chicago. Two new Radical-7 bedside monitors with different user interfaces, including a color display, will be available with Masimo SET with Rainbow technology for clinicians to continuously and noninvasively monitor their patients' carboxyhemoglobin (SpCO), methemoglobin (SpMet), oxygen saturation (SpO2), pulse rate, and perfusion index.

Masimo SET with Rainbow Technology has already proven to be effective in detecting carbon monoxide and methemoglobin poisoning in critical situations, allowing accurate diagnosis and early treatment of life-threatening conditions. Last month at a hospital in southern California, a patient was diagnosed with a Rainbow monitor to have a dangerously high level of methemoglobin. Because of this timely diagnosis, the patient was immediately treated, and the patient's life was saved.

Also, last month a hospital in Boca Raton, FL, used a hand-held Rainbow monitor, the Masimo Rad-57, to avert a potential disaster. Clinicians at the hospital, after using the Rad-57 to detect dangerous levels of carbon monoxide in a patient's blood, dispatched emergency services to the young man's condo complex and safely evacuated nearly 200 people from a 20-story building, where a faulty generator led to carbon monoxide levels 100 times greater than normal. As a result, there were no reports of permanent injury to any of the building's residents.

"We are proud of the scientific achievement in making noninvasive and continuous measurement of SpCO and SpMet possible, but life-saving incidents like the ones noted above bring a different kind of satisfaction to those accomplishments," explained Joe Kiani, Masimo chairman and CEO.

The Rainbow platform is based on Masimo's revolutionary and gold standard Signal Extraction technology—a high-performance pulse oximetry technology clinically proven accurate and reliable during periods of patient motion and low-peripheral perfusion. Although other pulse oximetry technologies use only two wavelengths of light to distinguish oxygenated from nonoxygenated hemoglobin, Masimo SET with Rainbow technology uses multiple (7+) wavelengths to noninvasively and continuously measure carboxyhemoglobin and methemoglobin in addition to oxygen saturation, pulse rate, and perfusion index. In addition, when used with Rainbow sensors, the Rainbow monitors employ a new probe-off technology called RAPOD, which can detect when the sensor has come off the patient more reliably than ever before.

Rainbow allows clinicians to be more confident of the accuracy of their SpO2 readings by giving them the ability to frame those measurements with the dyshemoglobins SpCO and SpMet. Neither SpCO nor SpMet can be distinguished from, and are often reported as, SpO2 by all other pulse oximeters, yet both are incapable of transporting oxygen, resulting in reduced blood oxygenation levels that can induce tissue hypoxemia. Peer-reviewed clinical studies have proven that the prevalence and significance of both these dyshemoglobins raise morbidity and mortality across the spectrum of acute care settings.

The Institute for Safe Medical Practice states that "methemoglobinemia is unlikely to be a rare occurrence," while authors from the 2004 Johns Hopkins University School of Medicine study(i) entitled "Acquired Methemoglobinemia," concluded "drugs that cause acquired methemoglobinemia are ubiquitous in both the hospital and the outpatient setting." The Johns Hopkins study had many key findings:

  • Acquired methemoglobinemia is ubiquitous in hospitals, from OR to the General Ward, and is independent of patient's age, from 4 days of age to 86 year of age.

     

  • More than 20 drugs that are used frequently in hospitals cause acquired methemoglobinemia, including 'caine' anesthetics, such as Benzocaine and Lidocaine; heart medications, such as nitroglycerin; inhaled nitric oxide used on premature infants and sometimes cardiac patients; and Dapsone, a powerful anti-infective that is commonly used on organ-transplant, AIDS, and dermatoses patients.

     

  • Methemoglobinemia can cause serious injury and even death, but can be treated if detected. During the study time, there were three near deaths and one death.

     

  • Nearly 20% of patients tested had elevated methemoglobin levels, and 25% of the cases were found accidentally.

     

  • The cost of doing invasive testing of methemoglobin is $35 each time, and during the 28-month period it would have cost the hospital $9 million.

"Before the advent of Masimo SET and Rainbow Technology, it was impossible for clinicians to reliably monitor their patients continuously for methemoglobinemia and carboxyhemoglobinemia, let alone oxygen saturation, and as a result many patients suffered. We are proud to once again bridge the gap between measurement and patient condition, by breaking the technological barriers and introducing SpCO and SpMet," Kiani continued. "But in addition to the current ability to monitor the level of SpCO and SpMet, Masimo is using the additional data delivered by the Rainbow technology platform and sensors to qualify an array of additional clinically valuable measurements. And because Masimo SET with Rainbow technology is designed as a technology platform, hospitals can easily upgrade to these additional new noninvasive clinical measurements when they become available without acquiring new hardware."

The Radical-7 is the "first" pulse oximeter to have a color screen. Additionally, to provide customers with maximum flexibility in their transition to Rainbow technology, each Masimo Radical-7 is fully field upgradeable, so customers can purchase the Radical-7, which comes standard with Masimo SET SpO2, pulse rate, and perfusion index, with Rainbow parameters, at the time of purchase, or have them field installed in the future. In June, Masimo received a prestigious Medical Design Excellence Gold Award for its Rad-57 handheld Pulse CO-Oximeter with Rainbow technology. In addition, the technology received the 2006 Application of Technology award from the Society for Technology in Anesthesia in January and was honored by the American Electronics Association as the Innovative Product winner in the Medical Technology category at its 13th Annual High Tech Awards ceremony in May.

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. In 2005, Masimo introduced Rainbow and with it, 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 on the company's Web site.

Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57, RAPOD, 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 Labs.


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