SOURCE: Masimo

Masimo

February 26, 2015 08:01 ET

Korean Regulators Clear Masimo PVI® for Clinical Use

NEUCHATEL, SWITZERLAND--(Marketwired - Feb 26, 2015) -  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® -- 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 postoperatively.4,5

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® or rainbow® sensor.

1 Cannesson M: Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth 24:487-497,2010
2 Brandstrup B, TønnesenH, 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. doi:10.1097/01.sla.0000094387.50865.23.
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®, 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® 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® 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®), and PVI®, in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at 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 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 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

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.

Contact Information