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Masimo is committed to delivering truthful information on its innovative products supported by scientific evidence.  However, Masimo receives frequent reports of claims made by our competitor that Masimo believes are misleading or false.We address some of these claims here so that customers may review the evidence themselves and make informed decisions.

Covidien Claim
The FACTS

Covidien is the only company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio that is also compliant with ISO 80601-2-61 (International Organization for Standardization) standards for pulse oximetry.

 

  • The ISO 80601 standard does not require performance improvement during motion, but requires the submitter to report the motion frequency and type of motion used for the study. All pulse oximeters that require an FDA submission after the standard has come into effect require reporting per this standard. An examination of the Nellcor/Covidien pulse oximeter FDA submissions shows that their pulse oximetry technology has remained unchanged per their FDA 510K summary. 1,2,3,4
  • Masimo invented measure-through motion and low perfusion pulse oximetry. Masimo was the first company to receive measure-through motion claims from the FDA in 19985 and was the first company to receive measure through-motion and low perfusion claims in 1999.6 Masimo supports all efforts to disclose additional validation methodology and protocols.
  • Masimo and other manufacturers also have newer pulse oximeters that have been subject to this new standard, so the additional claim that Covidien is the only company to receive clearance and compliance is also not factual.
  • This attempt by Covidien to create the illusion of exclusivity by aggregating two criteria and compliance with ISO 80601 is therefore misleading. A realistic comparison of the motion performance, which shows the superiority of the Masimo SET® technology, is illustrated by the plot comparing the performance of Masimo SET®, Nellcor-595 and N-600 devices. Click here for proof
  • Clinical study after study have evaluated the motion and low perfusion comparisons in live clinical settings and the fact is Masimo SET® pulse oximetry technology has consistently outperformed Nellcor/Covidien devices. Masimo is aware of at least 91 independent and objectives studies comparing Masimo and Covidien pulse oximetry technologies. Of the 91 comparative studies, 83 studies favor Masimo SET® pulse oximetry with 8 studies being neutral.
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Covidien Claim
The FACTS

Covidien offers the most accurate pulse oximetry technology that meets all of the CCHD requirements.

 

  • The critical performance requirement for pulse oximetry to be used for CCHD screening is to have the maximum sensitivity and specificity for identifying hypoxia. Studies have shown that Masimo SET® has better sensitivity and specificity for identifying hypoxic events compared to other pulse oximeters.
  • Masimo SET® pulse oximeters and sensors were exclusively used in the two studies (59,876 subjects) that were the basis for the CCHD workgroup recommendations7,8,9 for CCHD screening protocols.
  • There have been five published studies that used Masimo SET® pulse oximeters and sensors on 241,239 subjects, including the largest CCHD screening study to date, which screened over 122,738 subjects.10 These studies showed sufficient performance benefits to permit the worldwide clinical community to recommend CCHD screening with pulse oximetry.7,8,10,11,12
  • In contrast, Covidien also cites five studies using Nellcor pulse oximeters (over 33,000 subjects) for CCHD screening in their marketing materials.13,14,15,16,17 However, three of the five studies may not be appropriately powered to screen newborns for CCHD (2,000 to 3,300 subjects) since CCHD occurs in 1.2 per 1,000 live births.12,13,14,18 Researchers in one of the larger studies (15,233 subjects) concluded that "Our findings do not support a recommendation for routine pulse oximetry screening in seemingly healthy neonates."16
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Covidien Claim
The FACTS

During the BOOST-II trials, Masimo changed their calibration curve due to algorithm issues with the Masimo pulse oximeter.

  • The BOOST-II trial evaluated the impact of adjusting neonatal oxygen therapy to maintain SpO2 in one of two different SpO2 target ranges on the incidence of Retinopathy of Prematurity (ROP) and mortality in pre-term infants.The data generated by the trial prompted Masimo to make a slight change to its calibration curve, which is something each pulse oximeter manufacturer must determine empirically based on clinical data.  No changes were made to Masimo’s algorithm. 
  • As noted by the BOOST-II investigators, this clinical trial exclusively used Masimo SET® pulse oximeters with Masimo SET® technology: “The trials are using Masimo SET Radical pulse oximeters (Masimo, Irvine, California, USA). These oximeters were chosen because they were in widespread use when the trials were planned and are popular because of their ability to measure during patient motion and in circumstances of low perfusion.”
  • No other pulse oximeter technology has been evaluated systematically as in the BOOST-II trial to assess the clinical impact of titrating oxygen therapy to maintain specific SpO2 target ranges.
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Covidien Claim
The FACTS

A published study revealed an artifact in Masimo pulse oximeters that increased saturation values of 87-90% by an additional 2%. For CCHD, an increase from 89% to 91% could mask some cases of CCHD, resulting in false negative screens with the Masimo pulse oximeters.

  • The BOOST-II Study is referred to once more in this claim. Covidien’s claim is misleading because:
    • The BOOST-II trial evaluated the impact of adjusting neonatal oxygen therapy to evaluate the incidence of Retinopathy of Prematurity (ROP) and mortality in preterm infants not CCHD.
    • Masimo has updated its calibration curve, eliminating the issue.
    • Saturation values of 87 to 90% and 89 to 91% are NOT the target ranges for CCHD screening. CCHD screening is performed on healthy term infants with a target range greater than 95%.
  • Masimo SET® is the only pulse oximetry technology that has had positive impact on preterm infants to significantly reduce Retinopathy of Prematurity (ROP), a devastating blinding disease in preterm infants. Researchers have found that Masimo SET®, in combination with changes in clinical practice, led to a reduction in severe ROP.19
  • We are unaware of any study using Nellcor devices, that has shown the same clinical impact on preterm infants as Masimo SET® pulse oximetry.
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Covidien Claim
The FACTS

Nellcor performs just as well as Masimo during patient motion and low perfusion

  • There have been a total of 91 independent and objective studies that directly compare Masimo SET® and Covidien pulse oximetry technologies. Of the 91 comparative studies, 83 studies favor Masimo SET® pulse oximetry with 8 studies being neutral.
  • In a multicenter study on preterm infants at Emory University, researchers compared Masimo SET® and Nellcor and found that when combined with changes to clinical practice,only with Masimo SET® were they able to obtain significant reductions in severe ROP. In the same study the Covidien technology did not lead to a reduction in severe ROP even when a change in clinical practice was initiated.19
  • A critical performance measure to evaluate pulse oximeter performance is to determine its sensitivity and specificity to hypoxemia. Researchers have shown that Masimo SET® had the best sensitivity and specificity compared to 19 other pulse oximters including Covidien pulse oximeters.22 
  • A more recent study evaluated the Covidien N-600 device with Masimo SET® along with Datex-Ohmeda under motion conditions and found that Masimo SET® had a sensitivity and specificity of 97% and  93% versus Covidien which was at 77% and 67%.23
  • Obtaining reliable SpO2 measurements on pediatric patients with congenital heart disease is challenging.  The Masimo Blue Sensor® is first pulse oximetry sensor designed for cyanotic patients with FDA clearance for accuracy on cyanotic infants as low as 60%. An independent study on infants with CHD compared the accuracy of the Masimo Blue Sensor (with Masimo SET®)  versus the Nellcor Max-I Sensor (with Nellcor N-600 with Lo-Sat) compared to blood gas readings. The Masimo Blue sensor demonstrated the best accuracy (Arms = 3.83) compared to the Nellcor sensor (Arms = 5.71).24
  • Masimo offers hospitals a Performance Superiority Guarantee that Masimo pulse oximeters will outperform Nellcor oximeters on challenging patients. To the best of Masimo’s knowledge, not a single published study concludes that currently available Nellcor technology (N-600/N-600x) performs better than Masimo technology during conditions of motion and low perfusion.
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Covidien Claim
The FACTS

A Nellcor video illustrates that Masimo continues to provide measurements when there is no pulse by exhibiting detection of pulse on a subject while a dual-bladder tourniquet is inflated to 250 mmHg.

  • The video attempts to demonstrate a simulated pulseless and low perfusion state. During a true pulseless state—with sensors properly attached to a patient—it would be impossible for Masimo pulse oximeters to provide any measurement because it requires a pulsatile signal.
  • This video actually confirms the ability of Masimo pulse oximetry technology to accurately measure pulse rate even under very low perfusion. In contrast, the Nellcor pulse oximeter was unable to measure pulse rate under the low perfusion simulation and dashed out during the tourniquet inflation. This video further illustrates our point regarding the superior ability of Masimo pulse oximeters to provide measurements even under the most challenging conditions.
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Covidien Claim
The FACTS

Nellcor uses “cardiac-based” algorithm, while Masimo uses a “saturation-based” algorithm to determine oxygen saturation and pulse rate. Nellcor also states “Signal overprocessing can mask patient events from being displayed, thus driving inconsistent performance.

 

  • As the term Pulse Oximetry indicates, the presence of a pulse (a pressure wave originating from the heart and travelling to the measurement site typically on a digit) is a necessary condition for any pulse oximeter to function. A pulse oximeter uses light absorption information at different wavelengths to determine a saturation value. The presence of the pulse is a necessary pre-requisite in order to obtain the light absorptions to provide a saturation value.27  “Cardiac-based” and “saturation-based” are descriptors coined by Covidien that do not accurately describe the underlying technology and are therefore meaningless.
  • Masimo’s breakthrough SET technology has multiple engines that continuously assess the SpO2 saturation value (all of which require a pulsatile signal). We call these parallel signal processing engines, each of which examines the incoming pulsatile signal and evaluates a saturation value independently.
  • The reason for these engines is that during different operating conditions (motion, low perfusion, etc.) certain techniques used within these engines are better suited to provide a saturation value than others.
  • For example, during motion conditions, both arterial and venous blood move around in the digits and distort the pulsatile waveform, but the DST waveform will be able to distinguish the arterial saturation (higher saturation) from the venous saturation (lower saturation).
  • One of the Masimo parallel engines is the R/IR engine which is similar to the determination of saturation in conventional oximeters and this engine gets used when optimal measurement conditions (no-motion and good perfusion) exist. Other engines are also used to determine the saturation values.
  • Each of these engines is also able to generate a confidence value that allows the Masimo SET® technology to assess the various calculations.
  • The advantage of having the multiple engines is to enable Masimo SET® to continue to provide the appropriate saturation value based upon the operating condition.  For some conditions, the Covidien pulse oximeter will freeze or average the values when challenging conditions persist.
  • There are multiple studies, in multiple populations including adult, pediatric, infant, and neonatal (>3 kg), that conclude Masimo SET® provides more accurate measurements during challenging conditions than all other pulse oximeter technologies. Masimo is aware of at least 91 independent and objective comparison studies of Masimo SET® and Covidien pulse oximetry. Of the 91 comparison studies, 83 conclude positively for Masimo SET®, while 8 are neutral. 
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Covidien Claim
The FACTS

The Nellcor N-600x is accurate on cyanotic infants from 60% to 100% at plus or minus 3%.

 

  • Obtaining reliable SpO2 measurements on pediatric patients with congenital heart disease is challenging.Masimo recognized the need to develop a specific sensor for cyanotic patients and developed the Blue Sensor®. The Masimo Blue Sensor is the first pulse oximetry sensor designed for cyanotic patients with FDA clearance for accuracy on cyanotic infants as low as 60%.

    Masimo recognized the need to develop a specific sensor for cyanotic patients and developed the Blue Sensor®. The Masimo Blue Sensor is the first pulse oximetry sensor designed for cyanotic patients with FDA clearance for accuracy on cyanotic infants as low as 60%.

  • An independent study on infants with CHD compared the accuracy of the Masimo Blue Sensor  (with Masimo SET®) with the Nellcor Max-I Sensor (with Nellcor N-600 with Lo-Sat) compared to blood gas readings. The Masimo Blue Sensor demonstrated the best accuracy (Arms = 3.83) compared to the Nellcor sensor (Arms = 5.71 ).22
  • Nellcor claims to be accurate on cyanotic infants from 60% to 100%, however, the clinical validation involved testing on healthy adult subjects not cyanotic infants. Nellcor implies that since their technology has in the past been validated down to 60% on healthy adult subjects, that it will perform equally as well on patient (i.e., infants) in that hypoxic zone.
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References

  • 1 Covidien 510(k) summary- K123581
  • 2 Covidien 510(k) summary - K130320
  • 3 Covidien 510(k) summary - K141542
  • 4 Covidien 510(k) summary - K142865
  • 5 Masimo 510(k) summary - K973887
  • 6 Masimo 510(k) summary - Kpp2238
  • 7 de-Wahl Granelli AD et al. BMJ. 2009;338.
  • 8 Ewer AK et al. Lancet. 2011 Aug 27;378(9793):785-94.
  • 9 Kemper et al. Pediatrics. 2011: Vol 128; No 5: pp e1259-67.
  • 10 Zhao Q-m et al. The Lancet, Early Online Publication, 23 April 2014. doi:10.1016/ S0140-6736(14)60198-7.
  • 11 Meberg A et al. Acta Paediatr. 2009 Apr;98(4):682-6.
  • 12 de-Wahl Granelli A et al. Acta Paediatr. 2007 Oct;96(10):1455-9.
  • 13 Hoke TR et al. Pediatr Cardiol, 2002 Jul-Aug. 23(4): p. 403-9.
  • 14 Reich JD et al. J Pediatr, 2003 Mar. 142(3): p. 268-72.
  • 15 Arlettaz R et al. Eur J Pediatr, 2006 Feb. 165(2): p. 94-8.
  • 16 Sendelbach DM et al. Pediatrics, 2008 Oct. 122(4): p. e815-20.
  • 17 Walsh W. J Perinatol, 2011 Feb. 31(2): p. 125-9.
  • 18 Govindaswami, B. Neoreviews 2012;13;e724; Wren, Arch Dis Child Fetal Neo Ed. 2008
  • 19 Castillo A et al. Acta Paediatr. 2011 Feb;100(2):188-92
  • 20 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm309106.htm
  • 21 http://www.auntminnie.com/index.aspx?sec=ser&sub=def&pag=dis&ItemID=82583
  • 22 Barker SJ. Anesth Analg. 2002 Oct;95(4):967-72
  • 23 Shah N et al. J Clin Anesth. 2012 Aug;24(5):385-91
  • 24 Cox PN. New pulse oximetry sensors with low saturation accuracy claims- A clinical evaluation. Respir Care. 2006;51:OF-06-160
  • 25 Barker SJ MS. A Comparison of Nellcor N-395, N-595 and Masimo Radical Pulse Oximeters during motion and hypoxemia. Anesth Analg. 2003;97:A9
  • 26 All studies available at http://www.masimo.com/cpub/clinical-evidence.htm
  • 27 Moyle, J. (2002). Pulse Oximetry. London: BMJ Books.