IRVINE, Calif., Aug. 8, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that it has lifted the voluntary product recall the company imposed on the noninvasive finger sensor of its Pronto-7™ handheld device to improve the product's performance in low ambient temperatures. The Pronto-7 and new finger sensors are pending FDA 510(k) clearance in the U.S.
New product features and enhancements include the addition of Max Sensitivity Mode that allows measurement over a broader range of patients. The addition of three noninvasive sensor sizes permits the instrument to be used on a broader range of finger diameters. Each of the new sensors is color-coded to make size identification easy (Small-Yellow, Medium-Red, and Large-White).
Masimo Founder and CEO, Joe Kiani, stated: "We take the integrity of our design and our promises to our customers seriously. We worked through the recall until we had redesigned the sensor for Pronto-7 so that it would perform as intended in the broadest range of likely ambient temperatures. We are delighted to re-introduce the Pronto-7 and with it the potential impact of noninvasive hemoglobin spot-check measurements that offer healthcare providers around the world the opportunity to transform the way and amount of time it takes to deliver the right care, at the right time to patients. We believe that Pronto-7's latest features and enhancements will help clinicians to better assess more patients and make better clinical decisions based on the availability of these quick and noninvasive hemoglobin measurements."
As part of Masimo's premarket testing and verification process, over 14,443 Pronto-7 measurements were performed on 1,443 subjects at 14 sites and compared to hemoglobin measurements from a venous blood sample analyzed on a hematology analyzer (Coulter Counter). This testing resulted in a product specification of 1.0 g/dL for normal sensitivity mode and 1.1 g/dL for max sensitivity mode. While not a regulatory requirement, prior to lifting the voluntary recall Masimo elected to perform additional testing on Pronto-7 devices and sensors produced at a Masimo manufacturing facility. This additional testing included 474 subjects in three outpatient clinic-type environments. The hemoglobin measurements from the Pronto-7 and a point of care device using capillary blood (Hemocue) were compared to hemoglobin measurements from a venous blood sample analyzed on a Coulter Counter. The Hemocue showed a bias of -0.1 g/dL and a standard deviation of 1.6 g/dL, while the Pronto-7 showed a bias of was -0.1 g/dL and a standard deviation of 1.1 g/dL. Based on the clinical results obtained and positive feedback from clinicians, Masimo has initiated international availability of Pronto-7 in Europe, Middle East, Africa, South America, and Asia (except for countries requiring clearance, such as Japan).
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, Masimo introduced 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 be also 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 belief that repositioning the thermistor solves prior temperature measurement problems, risks related to our assumptions of the repeatability of clinical results obtained using the enhanced 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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