Friday, February 27th, 2015

NEUCHATEL, SWITZERLAND -- (Marketwired) -  Masimo

(NASDAQ: MASI) announced today that the Republic of Korea's Ministry

of Food and Drug Safety (MFDS) and the Korean Health Technology

Assessment (HTA) group have cleared Masimo's noninvasive PVI(R) -- a

measure of the dynamic changes in the perfusion index that occur

during one or more complete respiratory cycles -- for clinical use.


Korean regulators determined that PVI is an effective, noninvasive

way to predict fluid responsiveness in mechanically ventilated

patients. Regulators concluded PVI has higher accuracy of diagnosis

compared to static indices (central venous pressure, pulmonary

capillary wedge pressure), and similar accuracy diagnosis with

dynamic indices (cardiac output variability, pulse pressure

variability, blood volume amplitude variability, systolic pressure

variability). They stated: 


"Pleth Variability index (PVI) measurement measures pleth variability

non-invasively with the sensor on the skin of patients, so that there

is no issue for safety. 


"Therefore, PVI is safe and effective as (an) alternative

non-invasive PVI measurement to predict fluid responsiveness of

machine respiration patients who need fluid supply."


Clinicians commonly use fluid administration to improve haemodynamics

before, during and after surgery. Assessment of fluid responsiveness

-- the ability of the circulation system to increase cardiac output

in response to volume expansion -- is essential to guide fluid

therapy and optimize preload.(1) Too little fluid administration can

result in low perfusion in peripheral tissue, but too much fluid

administration can result in patients failing to respond to any

amount of volume expansion,(2,3) as well as fluid overload



This clearance by Korean regulators is similar to the decision of the

French Society for Anaesthesia and Intensive Care (SFAR), which in

2013 added PVI to guidelines for optimal haemodynamic management

during surgery.(6) Similar to Korean authorities, SFAR recommends the

use of "dynamic" parameters such as PVI that measure variations over

the respiratory cycle.


"We're excited to see another major country approve for clinical use

another one of our important noninvasive, physiological

measurements," said Masimo founder and CEO Joe Kiani. "From PVI, to

our rainbow measurements that include noninvasive haemoglobin, carbon

monoxide, and our newest noninvasive parameter, Oxygen Reserve Index

or ORI, that can help clinicians optimize oxygenation before and

during prolonged intubation, Masimo continues to innovate ways to

improve patient outcomes and reduce the cost of care by advancing and

creating new noninvasive measurements."


PVI is available with any Masimo SET(R) or rainbow(R) sensor.


(1) Cannesson M: Arterial pressure variation and goal-directed fluid

therapy. J Cardiothorac Vasc Anesth 24:487-497,2010

(2) Brandstrup B, TonnesenH, Beier-HolgersenR, etal: Effects of

intravenous fluid restriction on postoperative complications:

Comparison of two perioperative fluid regimens: A randomized

assessor-blinded multicenter trial. AnnSurg 238:641-648,2003 

(3) Marik PE, Cavallazzi R, Vasu T, etal: Dynamic changes in arterial

wave form derived variables and fluid responsiveness in mechanically

ventilated patients: A systematic review of the literature. Crit Care

Med 37:2642-2647,2009

(4) Kita T, Mammoto T, Kishi Y. Fluid management and postoperative

respiratory disturbances in patients with transthoracic esophagectomy

for carcinoma. J Clin Anesth. 2002;14(4):252-6.

(5) Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H,

Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH,

Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B,

Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F,

Danish Study Group on Perioperative Fluid T. Effects of intravenous

fluid restriction on postoperative complications: comparison of two

perioperative fluid regimens: a randomized assessor-blinded

multicenter trial. Ann Surg. 2003;238(5):641-8.


(6) Vallet B., Blanloeil Y., Cholley B., Orliaguet G., Pierre S.,

Tavernier B. "Strategy for perioperative vascular filling -

Guidelines for perioperative haemodynamic optimization." Experts'

Formalized Recommendations, French Society of Anaesthesia and

Intensive Care (SFAR), Validation by the administrative council of

SFAR on 19 October 2012. 


About Masimo

Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive

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(R), which virtually eliminated false alarms and

increased pulse oximetry's ability to detect life-threatening events.

More than 100 independent and objective studies have shown that

Masimo SET(R) outperforms other pulse oximetry technologies, even

under the most challenging clinical conditions, including patient

motion and low peripheral perfusion. In 2005, Masimo introduced

rainbow SET(R) Pulse CO-Oximetry technology, allowing noninvasive and

continuous monitoring of blood constituents that previously could

only be measured invasively, including total hemoglobin (SpHb(R)),

oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin

(SpMet(R)), and PVI(R), in addition to SpO2, pulse rate, and

perfusion index (PI). Additional information about Masimo and its

products may be found at


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 of the repeatability of clinical results obtained

using Masimo PVI, risks related to our belief that PVI is an

easy-to-use and cost-effective measure for assessing whether patients

will benefit from fluid administration, risks related to our

assumptions that PVI enables personalized and goal-directed fluid

therapy, 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 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


Masimo, SET, Signal Extraction Technology, Improving Patient Outcome

and Reducing Cost of Care... by Taking Noninvasive Monitoring to New

Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are

trademarks or registered trademarks of Masimo.


Media Contacts: 

Mike Drummond

Masimo Corporation

(949) 297-7434

[email protected]


perfusion index


More Formats