Business Wire

New Study Evaluates the Use of Masimo PVi ® to Monitor Volume Status in Spontaneously Breathing Hemodialysis Patients

Share

Masimo (NASDAQ: MASI) announced today the findings of a study published in the Turkish Journal of Emergency Medicine in which Drs. Seda Dağar and Hüseyin Uzunosmanoğlu at the Kecioren Training and Research Hospital in Ankara, Turkey investigated the role that noninvasive, continuous Masimo PVi® might play in monitoring volume status and volume changes in spontaneously breathing patients undergoing hemodialysis (HD).1 The researchers found that there was a “strong correlation” between change in PVi and the volume of fluid removed, concluding that “PVi may provide clinicians with useful information for monitoring the volume status in critically ill patients with spontaneous breathing.”

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210822005033/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Masimo Root® with PVi® (Photo: Business Wire)

More than 100 independent studies have demonstrated the utility of PVi as an indicator of fluid responsiveness.2 Noting that PVi has been studied mostly in mechanically ventilated patients, the researchers sought to investigate its ability to help assess volume changes in spontaneously breathing patients. They enrolled 60 adult patients with end-stage renal disease who received routine HD (during which fluid is removed simultaneously with the removal of waste solutes) and had a median of 3,500 cc of fluid removed during HD. PVi was measured using a Masimo pulse oximetry sensor attached to a Masimo Root® monitor, before and after HD, and changes in PVi were compared to the amount of fluid removed during the session.

The researchers found that mean PVi showed a statistically significant increase after HD, from 20.7% ± 5% to 27.7% ± 6% (p < 0.001). Based on the amount of fluid removed during HD, the change in PVi was statistically significant (p = 0.015) and was strongly correlated to the volume of fluid removed (r = 0.744, p < 0.001).

The researchers concluded, “In the present study, we found that the fluid removed by HD in spontaneously breathing patients caused an increase in PVi and that this increase was strongly correlated with the amount of volume change. Bedside monitoring of PVi, which is a noninvasive, fast, reproducible measurement parameter, may provide the clinicians with useful information for monitoring the volume status and evaluating the effectiveness of volume‑restoration therapy in critically ill patients with spontaneous breathing.”

The accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure, and device-related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi.

In the U.S., PVi is cleared as a noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients.

@Masimo | #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.3 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,4 improve CCHD screening in newborns,5 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.6-9 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,10 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.11 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7® and Radius PPG™, portable devices like Rad-67®, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97®. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, iSirona™, Patient SafetyNet, Replica™, Halo ION™, UniView®, UniView :60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

  1. Dağar S, Uzunosmanoğlu H. Assessment of pleth variability index in volume changes during ultrafiltration process. Turkish Journal of Emergency Medicine. 2021;21:111-6.
  2. Published clinical studies on PVi, with varying results and outcomes, can be found on our website at http://www.masimo.com/evidence/pulse-oximetry/pvi. Studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  3. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  4. 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.
  5. 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.
  6. Taenzer A 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.
  7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  8. McGrath S 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.
  9. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
  10. Estimate: Masimo data on file.
  11. 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 PVi®. 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 PVi, 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; risks related to COVID-19; 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Masimo
Evan Lamb
949-396-3376
elamb@masimo.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

TransferMate Global Payments Selects ComplyAdvantage For The Company’s Award-Winning AML And Risk Screening Solutions22.9.2021 10:57:00 CEST | Press release

Today ComplyAdvantage, a global data technology company transforming financial crime detection announced that TransferMate Global Payments, a leading global B2B-payments technology solution provider, has selected the reg tech innovator’s award-winning customer onboarding, transaction screening and monitoring solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005398/en/ Charles Delingpole, CEO of ComplyAdvantage (Photo: Business Wire) Headquartered out of Kilkenny, Ireland, TransferMate is a subsidiary of Clune Technology Group founded by Terry Clune and is a leading global B2B payments technology firm enabling companies to send and receive cross-border payments faster and easier. Now more than ever before, fast growing enterprises like TransferMate are implementing the best technologies and processes not only to reduce their risk profile as it relates to financial crimes but also to help accelerate service expan

Investable Universe Launches Provocative Polar Futures Media Series22.9.2021 10:15:00 CEST | Press release

The real assets news site Investable Universe announces the launch of Polar Futures, a media series that examines the eight-nation Arctic region’s growing geopolitical importance and its potential for attracting hundreds of billions of dollars in direct investment to develop the region and its bounty of natural resources. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005180/en/ Institutional investors, pension funds and other investors are eyeing the potential of developing infrastructure, shipping, logistics, telecommunications, mining, aquaculture and marine resources and of incubating technologies that aid the transition to renewable energy. Additionally, new trans-Arctic shipping lanes made more accessible by climate change will focus competing political and military interests on the polar zone. Nuanced insights from pivotal figures Against this fluid strategic backdrop, the weekly newsletter and podcast series, c

Aqara Introduces Smart Roller Blind Retrofit Solution22.9.2021 10:00:00 CEST | Press release

Aqara, a provider for smart home products, announced the launch of the Aqara Roller Shade Driver E1, a retrofit roller shade controller to automate the existing beaded chain roller shades. The roller shade driver fits beaded cord roller shades with the bead thickness of 3 - 6 millimeter, and works with both plastic and metal beads. The driver has been available on Amazon UK starting from September 22, 2021, and it is expected to land on Amazon France in the next few weeks. It will also be made available via authorized Aqara retailers in Europe and Asia in the following months. Shades are necessary for almost all homes, as they block harmful UV rays, save energy (for ACs and lights) and protect privacy. Automated shades save users the trouble of manually controlling the shades day in and day out, while helping to cut energy bills and enhance indoor comfort. The Roller Shade Driver E1 provides a quick, easy and cost-effective way to automate the existing roller blinds. The installation i

Flawed: Cayman Finance Challenges Credibility Of Tax Justice Network’s Biannual Financial Secrecy Index22.9.2021 09:10:00 CEST | Press release

Cayman Finance has today released a new study that critically assesses the methodology and data used to assess the Cayman Islands in Tax Justice Network’s (TJN) ‘Financial Secrecy Index’ (FSI). Significant flaws in TJN’s choice of data and scoring have rendered the 2020 report an unreliable source for accurate information about the Cayman Islands financial services industry. Future TJN reports’ will also lack credibility without critical changes in the application of their own methodology – and Cayman Finance will continue to scrutinise and analyse future editions to ensure continued accountability. Ahead of the anticipated publication of the other TJN reports this fall, Cayman Finance commissioned the review to analyse the calculations of the previous report published in 2020, which incorrectly placed the Cayman Islands first globally in its secrecy ranking. This analysis, by accomplished economist Julian Morris, identified significant flaws in how TJN applied its own original methodo

Forty Leading Organizations, Including 11 of the 20 Largest Dairy Companies in the World, Among First to Support New Global “Pathways to Dairy Net Zero” Climate Initiative22.9.2021 09:00:00 CEST | Press release

Pathways to Dairy Net Zero, a ground-breaking new climate initiative, is launching today during Climate Week and just prior to the United Nations (UN) Food Systems Summit. Forty leading organizations, including 11 of the 20 largest dairy companies in the world, have already declared their support for the effort. Collectively, these supporters represent approximately 30 percent of total milk production worldwide. The new climate initiative demonstrates the global dairy sector’s commitment to reducing GHG emissions while continuing to produce nutritious foods for six billion people and provide for the livelihoods of one billion people. “Pathways to Dairy Net Zero will accelerate climate efforts already underway and drive further necessary action to reduce dairy’s emissions over the next decades. The dairy sector has a lot to offer to lead this transition,” said Hein Schumacher, Chief Executive Officer of Royal FrieslandCampina and Chairman of Global Dairy Platform. “Mengniu is proud to j

Hughes and SES Demonstrate First Multi-Orbit SATCOM for Remotely Piloted Aircraft22.9.2021 08:50:00 CEST | Press release

Hughes Network Systems, LLC (HUGHES) and SES today announced the successful first demonstration of a new multi-orbit satellite communications (SATCOM) capability for remotely piloted aircraft. Conducted for General Atomics Aeronautical Systems, Inc. (GA-ASI), the demonstration paired Hughes HM series software-defined modems and Resource Management System (RMS) with SES’s satellites that operate in geosynchronous (GEO) and medium earth (MEO) orbits. SES’s unique multi-orbit fleet, which delivers global coverage, high throughput and security, was leveraged to show how unmanned aerial vehicles, such as the GA-ASI MQ-9 series, can maintain crucial connectivity and resiliency, even in contested environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210921006196/en/ Hughes and SES Demonstrate First Multi-Orbit SATCOM for Remotely Piloted Aircraft (Photo: Business Wire) The demonstration replicated a typical unmanned Intellig

LabGenius Appoints Dr. Didier Landais as Chief Operating Officer22.9.2021 06:00:00 CEST | Press release

LabGenius, the machine learning (ML)-driven protein engineering company, has announced the appointment of Didier Landais Ph.D. as Chief Operating Officer. In this role, Didier will leverage his wealth of experience in business and clinical development to lead the commercialization of LabGenius’ drug discovery platform, EVATM. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210921005586/en/ LabGenius Appoints Dr. Didier Landais as Chief Operating Officer (Photo: Business Wire) “I’m delighted that Didier has joined the team,” said Dr. James Field, Founder and CEO of LabGenius. “Didier is a seasoned operator with 30 years of pharmaceutical industry experience and I’m looking forward to working with him as we rapidly grow the company. It’s a testament to the progress we have made at LabGenius and the exciting opportunities we have ahead of us that we were able to attract someone of Didier’s calibre to join us on our journey.” Did

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom