BMEYE Receives CE Mark to Launch First Noninvasive Cardiovascular Monitor with Masimo Rainbow SET(R) Pulse CO-Oximetry(TM) Techn
January 21 2010 - 11:00AM
PR Newswire (US)
Incorporating Masimo's Breakthrough Noninvasive Hemoglobin and
Oxygen Saturation Measurements, ccNexfin Debuts to European Market
AMSTERDAM, and IRVINE, Calif., Jan. 21 /PRNewswire-FirstCall/ --
BMEYE B.V., the innovators of combined noninvasive, beat-to-beat
blood pressure and cardiac output monitoring, and Masimo
(NASDAQ:MASI), the inventor of Pulse CO-Oximetry and
Measure-Through Motion and Low-Perfusion pulse oximetry, jointly
announce today CE Mark certification and the European launch of the
BMEYE ccNexfin--the first noninvasive cardiovascular monitor with
Masimo Rainbow SET Pulse CO-Oximetry technology. The combination of
two innovative noninvasive technologies--BMEYE for cardiovascular
monitoring and Masimo Rainbow SET for hemoglobin and oxygen
saturation monitoring--provides real-time, beat-to-beat
measurements of cardiac, circulatory, and pulmonary parameters,
which may enable clinicians to detect impending cardiovascular
crisis before organ injury ensues. The ccNexfin with Masimo Rainbow
SET offers some of the most advanced cardiovascular monitoring
capabilities available today. It utilizes a single sensor finger
cuff (BMEYE) and finger sensor (Masimo Rainbow SET) to capture and
continuously measure beat-to-beat blood pressure (sys/dia), mean
arterial pressure (MAP), cardiac output (CO), stroke volume (SV),
systemic vascular resistance (SVR), derivative of pressure (dP/dt),
noninvasive hemoglobin (SpHb), oxygen saturation (SpO2), and
perfusion index (PI). This detailed data allows clinicians to
predict and proactively address the early signs of hemodynamic
instability during critical situations rather than reacting to late
indicators and their effects. "ccNexfin is a unique noninvasive,
beat-to-beat, and user friendly cardiovascular monitor that
delivers a patient's full hemodynamic profile based on real-time
data," stated Rob de Ree, CEO of BMEYE. "Masimo Rainbow SET Pulse
CO-Oximetry plays an integral role in the delivery of this rich
hemodynamic data stream by providing critical information about
oxygen delivery at the tissue level, which is an essential
component of accurate hemodynamic assessment." Assessment of
hemodynamic status is a cornerstone of critical care medicine,
routinely used to evaluate, diagnose, and direct therapy to manage
the care of at-risk and critically-ill patients. Hemodynamic
monitoring--the direct measurement of blood pressure inside the
veins, heart and arteries in relation to cardiac output and
systemic vascular resistance--allows clinicians to assess the
cardiovascular system and identify early circulation changes that
reflect small changes in the way the heart is working to deliver
blood and oxygen to tissues and organs. Hemodynamic monitoring has
traditionally relied upon invasive, costly, intermittent, or
unreliable methods to assist clinicians in maintaining adequate
oxygen delivery and tissue perfusion to prevent hypoxia and its
irreversible damage. The integration of ccNexfin and Masimo Rainbow
SET technologies into the emergency department, intensive care
units, and anesthesiology care areas has the potential to
facilitate earlier diagnosis and the delivery of protocol- and
goal-directed therapies that improve patient safety and clinical
outcomes. Masimo Founder and CEO, Joe Kiani, stated, "The risks and
costs associated with invasive hemodynamic monitoring techniques
leaves many high-risk patients underserved at a time when assessing
hemodynamic stability is most needed. The synergistic combination
of BMEYE and Rainbow SET means that continuous, noninvasive
hemodynamic monitoring can benefit more patients at all points
along the care path." About BMEYE BMEYE, a Dutch company based in
Amsterdam, The Netherlands, develops innovative medical devices
with broad application in clinical settings that require
cardiovascular monitoring. Specifically, BMEYE produces patient
monitors that noninvasively measure continuous blood pressure and
cardiac output. BMEYE's mission: BMEYE is the premier provider and
will set the standard of noninvasive, beat-to-beat, user-friendly
cardiovascular monitoring systems, to improve patient care and
reduce healthcare costs. About Masimo Masimo (NASDAQ:MASI) develops
innovative monitoring technologies that significantly improve
patient care--helping solve "unsolvable" problems. In 1995, the
company debuted Measure-Through Motion and Low Perfusion pulse
oximetry, known as Masimo SET®, which virtually eliminated false
alarms and increased pulse oximetry's ability to detect
life-threatening events. More than 100 independent and objective
studies demonstrate Masimo SET provides the most reliable SpO2 and
pulse rate measurements even under the most challenging clinical
conditions, including patient motion and low peripheral perfusion.
In 2005, Masimo introduced Masimo Rainbow SET® Pulse
CO-Oximetry(TM), allowing noninvasive and continuous monitoring of
blood constituents that previously required invasive procedures,
including total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)),
carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI®, in
addition to SpO2, pulse rate, and perfusion index (PI). In 2009,
Masimo introduced Masimo Rainbow SET® Acoustic Monitoring(TM), the
first-ever noninvasive and continuous monitoring of acoustic
respiration rate (RRa). Masimo's Rainbow platform offers a
breakthrough in patient safety by helping clinicians detect
life-threatening conditions and helping guide treatment options.
Founded in 1989, Masimo has the mission of "Improving Patient
Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring
to New Sites and Applications." Additional information about Masimo
and its products may be found at http://www.masimo.com/. 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 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 timing and market availability of ccNexfin with
Masimo Rainbow SET, risks related to our assumptions that the
integration of Masimo Rainbow SET with ccNexfin provides advanced
noninvasive and continuous hemodynamic monitoring capabilities that
have the potential to improve patient safety and outcomes by
assisting in the delivery of protocolized, goal-directed therapies,
risks related to our belief that the combination of Masimo Rainbow
SET and ccNexfin will enable clinicians to detect impending
cardiovascular crisis before organ injury ensues, 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
http://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
forward-looking 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. Media Contacts: Dana Banks
Masimo Corporation +1 (949) 297-7348 Masimo, SET, Signal Extraction
Technology, Improving Outcomes and Reducing Cost of Care by Taking
Noninvasive Monitoring to New Sites and Applications, Rainbow,
SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57, Rad-9,
Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are
trademarks or registered trademarks of Masimo Corporation.
DATASOURCE: Masimo; BMEYE B.V. CONTACT: Dana Banks of Masimo
Corporation, +1-949-297-7348 Web Site: http://www.masimo.com/
Copyright