Masimo (NASDAQ: MASI) announced today FDA clearance of
RAS-45, an acoustic respiration sensor for rainbow Acoustic
Monitoring® (RAM®), for infant and neonatal patients. RAM could
previously be used to monitor adult and pediatric patients greater
than 10 kg using RAS-125c and RAS-45 sensors. With clearance of the
RAS-45 sensor for infant and neonatal patients, acoustic
respiration rate measurement is now, for the first time, possible
for patients of all sizes, including neonates, in the United
States.
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the full release here:
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Masimo Root® with Radical-7®, RRa®, and
the RAS-45 Infant/Neonatal Sensor (Photo: Business Wire)
RAM noninvasively and continuously measures respiration rate
using an innovative adhesive sensor with an integrated acoustic
transducer, the RAS-45 and RAS-125c, applied to the patient’s neck
area or, for infant and neonatal patients under 10 kg, the chest.
Using acoustic signal processing that leverages Masimo Signal
Extraction Technology® (SET®), the respiratory signal is separated
and processed to display continuous respiration rate (RRa®) and an
acoustic respiration waveform, a visualization of the vibrations
caused by the patient’s airflow. The acoustic sensor also allows
clinicians to listen to the sound of a patient’s breathing, whether
at the bedside, through a point-of-care device like the Radical-7®
Pulse CO-Oximeter®, or remotely, from a Patient SafetyNet™ view
station.
The RAS-45 sensor for infant and neonatal patients offers
multiple benefits of particular importance for successfully
monitoring these youngest and most fragile patients. With the
clearance for newborns and neonates, RRa’s accuracy range has been
expanded up to 120 breaths per minute, while still providing
accuracy of +/- 1 breath per minute, facilitating accurate
measurement of the higher respiratory rates common in this
population. The sensor itself is significantly smaller than the
RAS-125c sensor, and in fact with a diameter of approximately 2.2
cm without adhesive is only slightly larger than a nickel.
Similarly, it weighs so little, 13 grams, that its presence may be
barely noticeable, and features an adhesive that is transparent,
light, and flexible. The size, weight, and adhesive advantages make
it particularly suitable for the smaller stature and delicate skin
of infants and neonates.
RRa has been shown not only to be accurate1,2 and reliable1, but
also easy-to-use1, easy-to-tolerate1,3, and to enhance patient
compliance with respiration monitoring. In a study comparing
pediatric patient tolerance of sidestream capnography with a nasal
cannula to respiration rate monitoring with an RAS-125c acoustic
sensor, 15 out of 40 patients removed the capnography cannula,
while only one removed the RAM acoustic sensor.3 In a study of 98
patients consciously sedated during upper gastrointestinal
endoscopy, researchers found that RRa monitoring with the RAS-125c
sensor more accurately assessed respiration rate than impedance
pneumography.2
Joe Kiani, Founder and CEO of Masimo, commented, “From the
beginning, we have focused our R&D on neonates and children for
many reasons, including our belief that helping clinicians care for
children will provide more benefit to society. RAM harnesses the
power of our breakthrough signal processing and sensor technology
and applies it to a measurement that has either been unreliable or
difficult to use, respiration measurement, the third vital
sign.”
RAM is available on most rainbow SET™-ready platforms.
Continuous monitoring of respiration rate can be helpful in cases
such as sedation-based procedures and post-surgical patients
receiving patient-controlled analgesia for pain management.4,5
@MasimoInnovates | #Masimo
The use of the trademark Patient SafetyNet is under license from
University HealthSystem Consortium.
References
- Macknet MR et al. Accuracy and
Tolerance of a Novel Bioacoustic Respiratory Sensor in Pediatric
Patients. Anesthesiology. 2007;107:A84 (abstract).
- Goudra BG et al. Comparison of Acoustic
Respiration Rate, Impedance Pneumography and Capnometry Monitors
for Respiration Rate Accuracy and Apnea Detection during GI
Endoscopy Anesthesia. Open J Anesthesiol. 2013;3:74-79.
- Patino M et al. Accuracy of Acoustic
Respiration Rate Monitoring in Pediatric Patients. Paediatr
Anaesth. 2013 Sep 3.
- Stoelting, RK et al. APSF newsletter.
2011. www.apsf.org.
- The Joint Commission Sentinel Event
Alert. Issue 49, August 8, 2012. www.jointcomission.org.
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 9 of the top 10 hospitals listed in the 2018-19 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
- 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.
-
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 RAS-45, RAM®, and
RRa®. 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 RAS-45, RAM, and RRa, 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.
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MasimoEvan Lamb, 949-396-3376elamb@masimo.com
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