United Kingdom's National Health Service Includes Masimo Pleth Variability Index® as "High Impact Innovation" for Intra Operative Fluid Management
Released as Part of Intra Operative Fluid Management Technologies Adoption Pack
LONDON, June 11, 2012 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today the National Health Service Technology Adoption Centre in the United Kingdom is advising hospitals to use Intraoperative Fluid Management Technologies as a way to improve patient outcomes, and included Masimo's noninvasive and continuous Pleth Variability Index (PVI®) among technologies available for helping clinicians manage fluid during surgeries.
"The use of Intraoperative Fluid Management Technologies (IOFMT) enables closer monitoring and management of patients' hydration status during major and high-risk surgery," the centre said in its Adoption Pack report. "Evidence shows that the use of this technology can facilitate improved outcomes for patients and benefits for the health economy."
The centre investigates, qualifies and supports new and innovative technologies that demonstrate benefits to patients and hospitals. The centre did not endorse one specific fluid-management tool. However, no other pulse oximetry technologies were included other than Masimo PVI.
Masimo PVI has been shown to help clinicians assess fluid responsiveness in adult surgical and intensive care patients under mechanical ventilation.(1,2) Two studies have shown that PVI helps clinicians assess fluid responsiveness similarly to a more invasive and costly technology (Edwards Vigileo Monitor, Flo Trac catheter).(3,4) Masimo PVI has also been shown to help clinicians improve fluid management to decrease patient risk in a randomized controlled trial.(5)
Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality.(6) Traditional invasive measurements such as central venous pressure are not reliable to predict whether a patient will benefit from fluid administration. Newer advanced monitoring technologies that have been shown to help clinicians assess fluid responsiveness and improve fluid management are invasive, complex, and/or costly. In contrast, Masimo PVI is noninvasive and easy to use, and has no incremental procedural cost because pulse oximetry monitoring is already performed on all surgical and intensive care patients. Once Masimo SET® pulse oximetry with PVI monitoring is available in a hospital, it can be considered in all patients in which an invasive arterial line or more complex or costly monitoring technologies may not be justified.
PVI is available on the Radical-7™ and Rad-87™ as well as select multiparameter patient monitors, such as Drager's Infinity® M540 and Welch Allyn's Connex® Vital Signs Monitor as part of Masimo rainbow® SET Pulse CO-Oximetry™ – the first-and-only technology platform to noninvasively measure blood constituents and fluid responsiveness that previously required invasive procedures, including: noninvasive and continuous total hemoglobin (SpHb™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and acoustic respiration rate (RRa™), in addition to the Measure-through Motion and Low-Perfusion performance of Masimo SET oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index.
Joe Kiani, Masimo's Founder and CEO said, "We applaud NHS' leadership in identifying processes and new technologies that can help advance medicine. Too many surgeries are performed throughout the world without assessing how patients will respond to fluid administration. The NHS's call for adoption of technologies to improve fluid management during surgeries is expected to improve patient outcomes. PVI is yet another innovation from Masimo that can play a major role in helping care providers around the world deliver better, more cost-effective care."
(1) Cannesson M., Desebbe O., Rosamel P., Delannoy B., Robin J., Bastien O., Lehot JJ. "Pleth variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre." British Journal of Anaesthesia August 2008; 101(2):200-6. Available online here.
(2) Loupec T., Nanadoumgar H., Frasca D., Petitpas F., Laksiri L., Baudouin D., Debaene B., Dahyot-Fizelier C., Mimoz O. "Pleth Variability Index Predicts Fluid Responsiveness in Critically Ill Patients." Crit Care Med. 2011 Feb;39(2):294-9.
(3) Zimmerman M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B., and Wiesenack C. "Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically-ventilated Patients Undergoing Major Surgery." European Journal of Anaesthesiology June 2010; 27(6):555-61. Available online here.
(4) Fu Q., Mi WD., Zhang H. "Stroke Volume Variation and Pleth Variability Index to Predict Fluid Responsiveness During Resection of Primary Retroperitoneal Tumors in Hans Chinese." BioScience Trends. 2012; 6(1):38-43 DOI: 10.5582/bst.2012.v6.1.38. Available online here.
(5) Forget P, Lois F, De Kock M. "Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management." Anesthesia & Analgesia. 2010 Oct;111(4):910-4.. Published online here.
(6) Bundgaard-Nielsen M et al. Acta Anaesthesiol Scand. 2007; 51(3):331-40
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive 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®, which 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 reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, the company introduced Masimo Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can also be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo 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.
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions of the repeatability of clinical results obtained using the new Masimo Pronto-7 and noninvasive sensor sizes, risks related to our belief that the Pronto-7 enables quick and easy noninvasive spot-checking of hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index at the point-of-care for all patients, as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
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