New Study Investigates the Clinical Utility of ORi™, Masimo Oxygen Reserve Index™, in Obese Patients
Masimo (NASDAQ: MASI) announced today the findings of an abstract presented at the annual meeting of the Society for Technology in Anesthesia (STA) in Miami, Florida. In the study, researchers at the UC Davis School of Medicine evaluated the potential clinical utility of Masimo Oxygen Reserve Index™ (ORi™) as an early warning of impending arterial hemoglobin desaturation in obese patients.1 This is the first published research investigating the utility of ORi in this particular population group.
ORi is a relative indicator of a patient’s oxygen reserve in the moderate hyperoxic region (partial pressure of oxygen in arterial blood [PaO2] in the range of 100 to 200 mmHg). As an “index” parameter with a unit-less scale between 0 and 1, ORi can be trended and has optional alarms to notify clinicians of changes in a patient’s oxygen reserve.
In the prospective, observational study, Dr. Ayala and colleagues analyzed data from 36 adult patients with BMI between 30 and 40 kg/m2 who were scheduled for elective surgical procedures requiring general anesthesia and endotracheal intubation. The patients’ ORi values were measured using a Masimo Root® Patient Monitoring and Connectivity Platform with Radical-7® Pulse CO-Oximeter®. The researchers recorded the time elapsed from the start of ORi alarming (triggered by decrease in the absolute value and rate of change in ORi) to 98% oxygen saturation, and considered this interval to be the average increase in warning time provided by ORi.
The researchers found that among the patients, the average time from the start of ORi alarming to 98% oxygen saturation was 42 ± 49 seconds (ranging from 5 to 255 seconds). Excluding two outliers, the average increase in warning time provided by ORi was 33 ± 23 seconds (ranging from 5 to 107 seconds).
The researchers concluded that the study “demonstrates the ability of ORi to provide advanced warning of arterial desaturation as an adjunct to SpO2 in this high risk patient population. This additional warning time can potentially translate to improved patient safety by allowing earlier calls for help, assistance from a more experienced person, or modification of airway management. For this analysis we defined the advance warning to end at 98% SpO2, with a defined trigger for intervention at 94% SpO2.”
In another study, researchers at Children’s Medical Center in Dallas, Texas concluded that ORi could provide clinicians with a median of 31.5 seconds advanced warning of impending desaturation in pediatric patients with induced apnea after pre-oxygenation.2
UC Davis received funding from Masimo for the ORi study.
ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
@MasimoInnovates | #Masimo
- Ayala S, Singh A, Applegate R, and Fleming N. Oxygen Reserve Index: Utility as Early Warning of Desaturation in Morbidly Obese Patients. Proceedings from the 2018 STA Annual Meeting, Miami, FL.
- Szmuk P et al. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study. Anesthesiology. 4 2016, Vol. 124, 779-784. doi:10.1097/ALN.0000000000001009.
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/cpub/clinical-evidence.htm.
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.
- 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.
- 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.
- 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.
- Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
- 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.
- Estimate: Masimo data on file.
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 ORi™. 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 ORi, 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.
Evan Lamb, 949-396-3376
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Takeda Receives Clearance from the European Commission for the Proposed Acquisition of Shire plc20.11.2018 17:33 | Tiedote
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION Takeda Pharmaceutical Company Limited (“Takeda”) announces that it has received clearance from the European Commission (the “EC”) for the proposed acquisition of Shire plc (“Shire”) announced on May 8, 2018 (the “Acquisition”). The EC’s approval is conditional on Takeda and Shire fulfilling commitments given to the EC in connection with the clearance. Specifically, in relation to the future potential overlap in the area of inflammatory bowel diseases between Takeda’s marketed product Entyvio (vedolizumab) and Shire’s pipeline compound SHP647, Takeda and Shire have committed to divest the pipeline compound SHP647 and certain associated rights. The divestment of SHP647 and certain associated rights is not a condition to the completion of the Acquisition. SHP647 is an exciting pipeline compound
ResMed Elects Harjit Gill to Its Board of Directors20.11.2018 17:05 | Tiedote
ResMed (NYSE: RMD, ASX: RMD), a leader in cloud-connected medical devices and out-of-hospital software-as-a-service business solutions, today announced it has elected experienced consumer and healthcare executive Harjit Gill to its Board of Directors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181120005179/en/ Harjit Gill, BA (Photo: Business Wire) Ms. Gill was elected by shareholders at its annual shareholder meeting last week in Sydney, Australia. Also, announced at that meeting, Gary W. Pace has retired from ResMed’s board after serving on it since July 1994. Ms. Gill’s appointment and Dr. Pace’s retirement both took effect Thursday, November 15. Ms. Gill has more than 25 years’ experience in health and consumer technology products as an executive, investor and regional business leader spanning Asia, Europe and the Middle East. From 1990 to 2015, she worked for Royal Philips as executive vice president and CEO for Phi
PTC Adds Artificial Intelligence and Generative Design Capabilities to Enhance and Expand its CAD Portfolio with Acquisition of Frustum20.11.2018 15:12 | Tiedote
PTC (NASDAQ: PTC) today announced that it has acquired Frustum Inc., an advanced generative design software company, for approximately $70 million. Frustum’s technology for generative design—an approach that leverages artificial intelligence (AI) to generate design options—is a transformative addition to the PTC Creo portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181120005326/en/ PTC Adds Artificial Intelligence and Generative Design Capabilities to Enhance and Expand its CAD Portfolio with Acquisition of Frustum (Graphic: Business Wire) Based in Boulder, Colorado, Frustum offers patented desktop and cloud-based engineering software that enables designers and engineers to go beyond the limits of their personal experience by leveraging powerful AI capabilities that guide the discovery of high-performance, next-generation product designs. “PTC is pushing the boundaries of innovation with this acquisition,” said Jim
United First Partners Launches UFP Fintech20.11.2018 15:00 | Tiedote
United First Partners (“UFP”), a leading independent Research, Brokerage, Advisory & Investment group is pleased to announce the launch of its latest venture: UFP Fintech. UFP Fintech invests in early stage Fintech, Proptech and Legaltech startups. Under the leadership of the entity’s CIO Christophe Petetin, a veteran investor in the Fintech space with an unparalleled investment track record in Fintech start-ups, UFP Fintech aims to become a global leader in Early Stage Fintech Investments. In recent years, Christophe and the UFP Fintech team have seeded a major unicorn and several other market leading entities. Christophe is a premier Fintech thought leader, who also acts in an advisory capacity to governmental and regulatory bodies, such as the FCA and ISO 20022 to create the next generation of standards for Fintech, payments, data, securities & digital currencies. Christophe commented “The financial industry is getting rebuilt from the ground up creating unprecedented opportunities.
LEO Pharma and PellePharm Announce $760 Million Collaboration to Advance Innovative Therapies for Rare Skin Diseases20.11.2018 14:00 | Tiedote
Danish dermatology specialists LEO Pharma and California rare disease pioneers PellePharm today announced a strategic development and commercialization collaboration to address unmet medical needs across various skin diseases with no approved treatments, advancing innovation and access to potential therapies for patients with life-altering conditions, such as Gorlin Syndrome and High Frequency Basal Cell Carcinoma (BCC), two distinct and rare forms of skin cancer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181120005227/en/ “We are very excited about the partnership with PellePharm, who are pioneers in Gorlin Syndrome and experts in rare skin diseases. Supporting our ambitious 2025 strategy, it marks LEO Pharma’s entrance in rare skin diseases and it offers a unique opportunity to bring the first treatment forward to people suffering from a very severe skin disease for which there currently are no approved therapies,” sai
IDEMIA Provides SK Telecom in South Korea with GMSA Compliant Smart Connect Solution to Activate and Manage eSIM Device Lifecycles20.11.2018 12:00 | Tiedote
IDEMIA, the global leader in Augmented Identity, is proud to have been selected by SK Telecom, the number one telecommunication operator in South Korea, to launch the first eSIM Connected watch based on GSMA Consumer standards. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181120005231/en/ Crédits : IDEMIA As a leading actor in the telecom field, IDEMIA is at the forefront of the digital revolution and is committed to bringing protected and convenient experiences to mobile operator customers. Leveraging its industrial leadership and appetite for innovation, IDEMIA will be providing SK Telecom its GSMA compliant solution. Based on IDEMIA’s Smart Connect Subscription management solution also known as remote SIM provisioning, the technology remotely connects the eSIM of the smart watch to the SK Telecom’s network without inserting a physical SIM card. This technology is also compliant with the latest GSMA standards ensuring in
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme