Press release
Masimo PVi® Receives FDA Clearance as an Indicator of Fluid Responsiveness on Mechanically Ventilated Patients
IRVINE, Calif.--(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) today announced that PVi® has received FDA clearance as a continuous, noninvasive, dynamic indicator
About this update from Masimo Corporation
[{"type":"text","content":" IRVINE, Calif.--(BUSINESS WIRE)--\nMasimo (NASDAQ: MASI) today announced that PVi® has received FDA clearance as a continuous, noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. PVi, or pleth variability index, is a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200814005094/en/Masimo Root® with PVi® and SpHb® (Photo: Business Wire)\n\nWilliam C. Wilson, MD, MA, Chief Medical Officer at UCI Health, said, “Anesthesiologists and critical care physicians have long recognized the importance of dynamic measures of intravascular volume and fluid responsiveness. Previously this data could only be acquired using an invasive arterial line, and/or additional sophisticated devices. With the Masimo pleth variability index (PVi), one can now obtain this essential data using the pulse oximeter probe and following the continuous readout on the monitor. The PVi technology has undergone rigorous peer-reviewed evaluation, and demonstrated efficacy in determining adequacy of intravascular volume for guiding goal-directed therapy. The recent clearance of the Masimo PVi system will serve as another major breakthrough in promoting patient safety.”\n\n\nAvailable alongside Masimo SET® pulse oximetry and rainbow® Pulse CO-Oximetry on a variety of 2-LED, 4-LED, and 8-LED Masimo sensors, PVi is an index between 0 and 100 that is calculated using a proprietary algorithm based upon the relative variability of the pleth waveform.\n\n\nHospital protocols such as Enhanced Recovery After Surgery (ERAS) and Goal-directed Therapy (GDT) recommend fluid management as part of larger initiatives designed to improve patient care and safety. Fluid management protocols look to balance fluids by identifying when patients may be fluid responsive. The utility of PVi as a fluid responsiveness indicator has been demonstrated in more than 100 independent, published studies, including in ERAS and GDT protocols.1 For example:\n\n\n\nERAS: In a study of 109 patients undergoing colorectal surgery, researchers found that the implementation of an ERAS protocol which included PVi led to substantial reductions in lengths of stay (from a median of 5 days to 3 days...