Business Wire

New Study Investigates the Utility of Home Monitoring Using Masimo SET® Pulse Oximetry to Screen Children with Down Syndrome for Risk of Obstructive Sleep Apnea Prior to Diagnostic Multichannel Sleep Studies

Del

Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers investigated whether home pulse oximetry monitoring might be a useful initial screening method of determining which children with Down syndrome (DS) – who are at high risk of obstructive sleep apnea (OSA) – be recommended to undergo multichannel sleep studies to diagnose the condition. The home monitoring was conducted using Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry.1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180813005147/en/

Masimo Radical-7® Pulse CO-Oximeter® (Photo: Business Wire)

Masimo Radical-7® Pulse CO-Oximeter® (Photo: Business Wire)

Noting that OSA “can only be reliably diagnosed using multichannel sleep studies, which are expensive, demanding for families and only available in specialist centres,” Dr. Hill and colleagues at the University of Southampton and Southampton Children’s Hospital sought to determine whether home pulse oximetry monitoring could identify children at high risk of OSA, and in particular which parameters could most sensitively detect this risk, as an initial screening step. To that end, they studied 161 children with DS, aged 0.5 to 6 years, of whom 25 were separately diagnosed with OSA. The patients were monitored overnight using Masimo Radical-7® Pulse CO-Oximeters®, with pulse oximetry sensors placed on the great toe. Recorded measurements included: total artifact-free time analyzed, mean oxygen saturation (SpO2), minimum SpO2, 3% oxyhemoglobin desaturation index (ODI), delta 12s index (the absolute difference between successive 12 second interval recordings, a measure of baseline SpO2 variability) and the number of minutes per hour that SpO2 was below 90%.

Receiver operating curves (ROC) and area under the curve (AUC) statistics were calculated to determine which measurements, alone and in combination, best predicted OSA status. During data analysis, researchers were blinded to which children had separately received a diagnosis of OSA. The researchers found that “the greatest AUC was achieved by the delta 12s index. At a threshold of >0.555, this identified 23/25 (sensitivity 92%) OSA cases and 89/136 true negatives (specificity 65%). The same sensitivity was achieved for 3% ODI with marginally lower specificity of 63% (86/136 true negatives).” The combined model (delta 12s index, 3% ODI, mean and minimum SpO2) detected all true positives (100% sensitivity) but with lower specificity (53%). This result would lead 60% of the sample population (12 true positives and 18 false negatives) to confirmatory multichannel studies.

The researchers concluded that “universal screening for OSA in children with DS using simple pulse oximetry parameters could halve the number of children requiring specialist multichannel studies. Pulse oximetry is widely available, well tolerated, readily acquired in the home and its adoption could reduce the burden on health services and families alike.”

The researchers noted that “our findings specifically apply to parameters generated by Masimo oximeters and cannot be generalised to other devices. Masimo technology extracts motion artefact, this is important in children with DS who are restless sleepers.” They also noted that “the use of a retrospective clinical dataset, with anonymous data shared for this analysis, limits our information on the wider sampling frame, demographic and clinical characteristics of these children.”

Masimo pulse oximetry is not cleared in the United States to screen children with Down syndrome for risk of obstructive sleep apnea.

@MasimoInnovates | #Masimo

Reference

  1. Hill C, Elphick H, Farquhar M, Gringras P, Pickering R, Kingshott R, Martin J, Reynolds J, Joyce A, Gavlak J, and Evans H. Home oximetry to screen for obstructive sleep apnoea in Down syndrome. Arch Dis Child. doi:10.1136/archdischild-2017-314409.

About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect® (MOC-9®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor, iSpO2 ® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

  1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
  2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
  3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
  4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
  6. Estimate: Masimo data on file.
  7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

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 include, among others, statements regarding the potential effectiveness of Masimo SET® and Radical-7®. 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 regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SET® and Radical-7, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; 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.

Contact information

Media Contact:
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Interxion Announces Direct Connectivity to Google Cloud Platform across Its European Footprint14.8.2018 08:00Pressemelding

INTERXION HOLDING NV (NYSE: INXN), a leading provider of carrier and cloud-neutral colocation data centre services in Europe, today announced that dedicated access to Google Cloud Platform (GCP) is now available across its European footprint through Cloud Connect, Interxion’s multi-cloud interconnection platform. With Google Cloud deploying its Cloud Interconnect points of presence (PoPs) in Interxion’s Paris, Marseille, Frankfurt and Stockholm data centres, customers can now directly connect to Google Cloud Platform from these locations. Moreover, because Interxion is a partner of Google Cloud’s newly launched Partner Interconnect service, customers can also connect from any of Interxion’s data centres across Europe via Cloud Connect. Customers using this service benefit from fully redundant, instant access to GCP from multiple metropolitan areas, ensuring a 99.99% availability SLA without the complexity and costs of having to build a networking solution themselves. “We are seeing str

Lumileds Wins Jury Verdict of Liability for Intellectual Property Theft Against Elec-Tech International Co., Ltd., Donglei Wang, and Gangyi Chen13.8.2018 22:45Pressemelding

On August 10, 2018, a jury of six men and six women rendered a verdict in favor of one the world’s leading LED companies, Lumileds LLC, based in San Jose, finding that a Chinese competitor stole trade secrets related to Lumileds core technology for making high power LEDs used in flash phones, automotive headlights, and general illumination. The case, Lumileds LLC v. Elec-Tech International Co., Ltd., Donglei “Tony” Wang, and Gangyi Chen, Superior Court of the State of California, County of Santa Clara, found the defendants liable for damages in intellectual property theft. The jury awarded Lumileds $66 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180813005694/en/ Mark Adams, Chief Executive Officer at Lumileds Inc. (Photo: Business Wire) The jury concluded that ETI, Wang and Chen misappropriated Lumileds trade secrets, took them to China, and used them to develop ETI’s LED technology. The award of $66 million is t

Growing Turkish Lira Crisis Drives Investors to Seek Safe Haven in Gold13.8.2018 13:34Pressemelding

The currency crisis engulfing the Turkish Lira is likely to intensify this week as the contagion becomes more widespread around the world. The volatility on the currency exchanges has led investors to pursue the stability offered by safe havens such as gold, which saw a hike in value by 0.4 per cent coinciding with the crash of the Lira. 1 Tom Coughlin, CEO of Kinesis, the bullion backed blockchain monetary system, comments: “The sharp rise in the price of gold seen in the past few days off the back of the Turkish Lira crisis, reflects a rising trend amongst investors wanting to protect their investments, from volatility caused by political instability. This is supplemented by the growing trend of decentralisation which has driven the underlying price of gold up 2% since the start of the year.” Investment in blockchain has doubled in the past year, with 82 per cent of ICO investors citing decentralisation as the main driver behind their investment. 2 Despite this trend, blockchain inve

Seoul Semiconductor’s Innovative SunLike LEDs Earn Industry Recognition in 2018 IES Progress Report13.8.2018 13:00Pressemelding

Seoul Semiconductor (KOSDAQ 046890), a leading global innovator of LED products and technology, has announced that its SunLike Series natural spectrum LEDs, powered by TRI-R, were recognized in the 2018 Illumination Engineering Society (IES) Progress Report, presented on August 10, 2018 at the IES Annual Conference in Boston, MA. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180813005229/en/ Seoul Semiconductor’s SunLike was recognized in the 2018 IES Progress Report (Graphic: Business Wire) As the recognized technical and educational authority on illumination, IES annually announces significant new advancements in lighting products, research, publications, and design tools in its IES Progress Report. Acceptance is based on an impartial judging process used by the committee to evaluate each submission on its uniqueness, innovation and significance to the lighting industry. SunLike Series natural spectrum LEDs are the world’

Skunkworks Surfing Co. Co-Founders Appointed to be Endowment for Clean Oceans Judges13.8.2018 11:07Pressemelding

The Endowment for Clean Oceans (ECO) announced that Skunkworks Surfing Co. Co-Founders CEO Chris and Ricky Martin have been selected and they have accepted to be ECO judges. Chris will serve on the Science and Tech Committee, and Ricky on the Entrepreneur Committee. An entrepreneur’s survival depends on their ability to execute their technical vision. “They have the sort of innovative entrepreneur and plastic materials technical expertise we are looking for to be ECO judges,” said Daniel Perrin, Founder and CEO of ECO. The role of the Entrepreneur Committee is to judge each entry to ECO’s two contests for scalability and executability. The Scientific and Technical Committee evaluate each entry from that perspective. “We are extremely excited to be part of this important and historic work,” said the Martin brothers. ECO’s contests are simply to provide a $1 million prize for an actionable and scalable plan to remove the micro and macro pieces of plastic from the ocean, and for the $5 mi

Calvin Klein Fragrances Releases CALVIN KLEIN WOMEN Global Television Advertising Campaign Featuring Actors Lupita Nyong'o and Saoirse Ronan13.8.2018 11:00Pressemelding

Calvin Klein, Inc., a wholly owned subsidiary of PVH Corp. [NYSE: PVH], and Calvin Klein Fragrances, a division of Coty Inc. [NYSE: COTY], today revealed the worldwide television advertising campaign for CALVIN KLEIN WOMEN, the first CALVIN KLEIN fragrance to be developed under the vision of Chief Creative Officer Raf Simons. The campaign features Lupita Nyong'o and Saoirse Ronan. Directed by artist Anne Collier with creative direction from Lloyd & Co., the television campaign unfolds into a series of vignettes that provide a glimpse into Lupita Nyong'o’s and Saoirse Ronan’s creative inspirations. An extension of the print campaign, the commercial follows both women as they reflect on and embrace figures from the past that have inspired them and shaped their identities as women. Viewers see Saoirse playing a Nina Simone record and sharing admiration for Sissy Spacek, while referencing her on the cover of a vintage magazine, while Lupita draws inspiration from beautiful collaged photogr