Korean Regulators Clear Masimo PVI(R) 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
"We're excited to see another major country approve for clinical use another one of our important noninvasive, physiological measurements," said
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,
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,
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