• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA

    LifeQ Unveils New 24-Hour Sleep Solution

    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll

    EvoEndo Names CEO and Chief Operating Officer

    Electromedical Products International Forms Scientific Advisory Board
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Computer Concepts for Medical Device Design

    IVD Manufacturers Are Being Put to the Test

    The New State of Medtech Outsourcing

    The Changing Face of Medtech Surface Treatment

    The Totally Tubular Technologies that Support Medical Devices
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Checking Up on Surgical Robotics

    Building a Network: How Synchron Is Developing a New Device—and a New Market

    Six Lessons Learned on Developing a Strong Company Culture

    As Hiring Slows, Companies Look Inward to Fulfill Talent Needs

    Artificial Intelligence: Medtech Opportunity or Health Danger?
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Medbio LLC

    LEMO USA Inc.

    JBC Technologies

    Cirtec Medical

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    6 Considerations for Companies on the Cusp of Being Acquired

    3 Key Elements to Consider When Managing a Medtech Sales Force

    Tech-Enabled Virtual Speech Therapy Improves Speech & Communication Skills

    Practical Strategies for Digitization and Integration in Medtech Manufacturing

    Sensors: The Heart of Minimally Invasive Equipment Technology
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    LEMO USA Inc.

    JBC Technologies

    Cirtec Medical

    Fusion Biotec Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA Clears Masimo's PVi Perfusion Measure for Mechanically Ventilated Patients

    PVi, or pleth variability index, is a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.

    Business Wire08.14.20
    Masimo announced 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.
     
    William C. Wilson, M.D., 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.”
     
    Available 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.
     
    Hospital 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:
     
    • ERAS: 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), complication rates (from 30.1 percent to 14.7 percent), and costs per patient (from mean cost at 30 days of $20,435 to $13,306 per patient)—in addition to improved patient satisfaction.2
    • GDT: In a study of 82 patients undergoing major abdominal surgery, researchers found that GDT with fluid management using PVi reduced the volume of intraoperative fluid infused and reduced intraoperative and postoperative lactate levels.3
     
    In addition, PVi has been used in combination with Masimo’s noninvasive, continuous hemoglobin monitoring technology (SpHb). In a study published last year involving 18,716 surgical patients at a hospital in Limoges, France, researchers investigated the effects of implementing a hospital-wide protocol for fluid management and blood administration using PVi and SpHb. The researchers found that use of an integrated GDT algorithm using both PVi and SpHb led to earlier transfusion and fewer units of blood transfused, as well as a 33 percent lower mortality rate 30 days after surgery and a 29 percent lower mortality rate 90 days after surgery. A year after the study ended, when the hospital did not use PVi and SpHb technology, the mortality rate returned to levels similar to those found before implementation of the GDT protocol.4
     
    Stephen Weston, M.D., Health Sciences Associate Clinical Professor and Medical Director, Operating Room Support Services, Department of Anesthesia and Perioperative Care at the University of California, San Francisco, said, “At UCSF we display PVi on all of our Masimo pulse oximeters. PVi is a great tool for helping to assess the patient’s fluid status. Having a fluid responsiveness monitor incorporated into something as ubiquitous as pulse oximetry allows us to monitor fluid responsiveness universally. I integrate PVi into my routine sweeps of the hemodynamic data in the operating room, and we’ve rolled out this functionality to the intensive care units as well. Without PVi, I feel that I’m flying a little bit blind.”
     
    Joe Kiani, Founder and CEO of Masimo, said, “We are thrilled that at long last we are able to offer clinicians and patients in the U.S. the full benefits of PVi monitoring. Multiple studies have shown how this breakthrough noninvasive indicator of fluid responsiveness can help improve outcomes and reduce costs on mechanically ventilated patients—with no more equipment needed than a software upgrade with most existing Masimo SET and rainbow platforms and the existing Masimo SET sensors that so many top hospitals around the world already use for pulse oximetry.”
     
    The accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure, and device-related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi.
     
    SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
     
    The GDT and ERAS studies summarized above were conducted on patients undergoing specific types of procedures and following specific fluid management protocols. The results may not be reflective of all cases and the described GDT and ERAS protocols may not be appropriate for all types of patients and procedures.
     
    References
    1 Published clinical studies on PVi, with varying results and outcomes, can be found on our website at http://www.masimo.com/evidence/pulse-oximetry/pvi. Studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
    2 Thiele RH et al. Standardization of care: impact of an enhanced recovery protocol on length of stay, complications, and direct costs after colorectal surgery. J Am Coll Surg. 2015 Apr;220(4):430-43.
    3 Forget P et al. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4.
    4 Cros J et al. Continuous hemoglobin and plethysmography variability index monitoring can modify blood transfusion practice and is associated with lower mortality. J Clin Monit Comp. 3 Aug 2019. https://doi.org/10.1007/s10877-019-00367-z.
    Related Searches
    • Patient Monitoring
    Related Knowledge Center
    • Patient Monitoring
    Suggested For You
    Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    Masimo Masimo's Rad-G With Temperature Earns CE Mark
    FDA OKs Masimo’s Rad-G Pulse Oximeter FDA OKs Masimo’s Rad-G Pulse Oximeter
    Masimo Expands the Masimo SafetyNet Remote Patient Management Solution Masimo Expands the Masimo SafetyNet Remote Patient Management Solution
    Masimo Introduces Neurostimulation Device for Opioid Withdrawal Symptoms Masimo Introduces Neurostimulation Device for Opioid Withdrawal Symptoms
    Innovative Health Cleared by FDA to Reprocess Transseptal Needles Innovative Health Cleared by FDA to Reprocess Transseptal Needles
    FDA Authorizes New Quest Lab Technique to Boost COVID-19 Testing Capacity FDA Authorizes New Quest Lab Technique to Boost COVID-19 Testing Capacity
    ZOLL Receives FDA Premarket Approval for AED With Enhanced Real CPR Help ZOLL Receives FDA Premarket Approval for AED With Enhanced Real CPR Help
    FDA Grants Breakthrough Device Designation for Ethicon’s Microwave Ablation Technology FDA Grants Breakthrough Device Designation for Ethicon’s Microwave Ablation Technology
    Beckman Coulter Receives FDA Clearance for Automated Microplate System Beckman Coulter Receives FDA Clearance for Automated Microplate System
    OraRisk COVID-19 RT-PCR Test Receives EUA OraRisk COVID-19 RT-PCR Test Receives EUA
    Paige’s FullFocus Viewer Cleared by FDA Paige’s FullFocus Viewer Cleared by FDA
    BD Helps U.S. Government Increase COVID-19 Testing Capacity BD Helps U.S. Government Increase COVID-19 Testing Capacity
    Combination Products Update—Mike on Medtech Combination Products Update—Mike on Medtech
    Getinge Getinge's Servo-air Mechanical Ventilator Receives 510(k) Clearance

    Related Breaking News

    • Patient Monitoring
      Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe

      Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe

      Uses 12 LEDs to simultaneously offer 12 blood constituent parameters noninvasively and continuously.
      Business Wire 09.13.21

    • Masimo

      Masimo's Rad-G With Temperature Earns CE Mark

      Rad-G can be converted from a handheld spot-check device into a continuous monitoring device, in the absence of other multi-parameter monitors.
      Michael Barbella, Managing Editor 03.24.21

    • Patient Monitoring
      FDA OKs Masimo’s Rad-G Pulse Oximeter

      FDA OKs Masimo’s Rad-G Pulse Oximeter

      Rugged handheld device provides clinically proven Masimo SET pulse oximetry and respiration rate monitoring.
      Business Wire 09.28.20


    • Patient Monitoring
      Masimo Expands the Masimo SafetyNet Remote Patient Management Solution

      Masimo Expands the Masimo SafetyNet Remote Patient Management Solution

      The Radius Tº Wearable Temperature Sensor automates remote monitoring of patient temperature status.
      Business Wire 09.21.20

    • Masimo Introduces Neurostimulation Device for Opioid Withdrawal Symptoms

      Masimo Introduces Neurostimulation Device for Opioid Withdrawal Symptoms

      Bridge device was found to reduce opioid withdrawal symptoms within 15-30 minutes and provide continuous relief for as long as it was applied.
      Business Wire 08.28.20

    Loading, Please Wait..

    Trending
    • Healthcare Changes Prompt Medtronic To Merge Sales Force Medtronic, Inc. Is Combining Its U.S. Ca
    • Philips Names New Supervisory Board Chairman
    • A New Approach To Post-Market Surveillance
    • FDA Clears Sanara MedTech's Advanced Surgical Solution
    • Titan Medical Licenses Most IP To Intuitive; CEO Steps Down
    Breaking News
    • CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    • LifeQ Unveils New 24-Hour Sleep Solution
    • Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    • EvoEndo Names CEO and Chief Operating Officer
    • Electromedical Products International Forms Scientific Advisory Board
    View Breaking News >
    CURRENT ISSUE

    May 2023

    • Computer Concepts for Medical Device Design
    • IVD Manufacturers Are Being Put to the Test
    • The New State of Medtech Outsourcing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Stefan Pasiakos, PhD, Selected to Lead NIH Office of Dietary Supplements
    Verdure Sciences Receives Award for Sustainable, Ethical Turmeric Sourcing
    BGG Receives Patent for Saw Palmetto ID Method
    Coatings World

    Latest Breaking News From Coatings World

    Indorama Ventures and Carbios Reaffirm Partnership to Build PET Biorecycling Plant
    AkzoNobel Powder Coatings Enhances Digital Services with Launch of My Interpon Portal
    PPG Opens Color Creation Lab with Chery Automobile in China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    CardioRenal’s TENOR Device Receives Breakthrough Device Designation from FDA
    LifeQ Unveils New 24-Hour Sleep Solution
    Babson Diagnostics Welcomes New Clinical Advisor, Andrew Carroll
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Terran Biosciences, Pierre Fabre Ink Exclusive Licensing Deal for Idazoxan
    ASM Research Chemicals Launches Development Packs for API Manufacturing
    WuXi Increases Manufacturing Capacity in Germany
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    L'Oréal North Asia President Discusses China's Consumer Sector Recovery & Premium Beauty Trends
    Kiehl’s Celebrates Pride by Supporting The Trevor Project
    L’Oréal & UNESCO Announce 2023 Laureates of the For Women in Science International Awards
    Happi

    Latest Breaking News From Happi

    Olay Rolls Out Sensitive Skin Line
    World Taste & Smell Association's June 6 Webinar Looks at Smell and Multisensory Design
    Azelis Americas Opens New Application Labs for Personal Care, Home Care and Industrial Cleaning
    Ink World

    Latest Breaking News From Ink World

    Mactac Acquires Canadian Roll Label Distributor Label Supply
    WestRock Advances its Commitment to a Sustainable Future
    Roland DGA Announces Key Service Department Personnel Changes
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Schreiner's Pharma-Comb IL Label supports clinical trial cancer medication
    First Anytron ANY-JET III digital label press installed in Korea
    FPA announces Kasie Fairbarn as elected ELC co-chair
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Harper Hygienics Launches Hemp-Based Intimate Care Wipes
    What You’re Reading on Nonwovens-Industry.com
    Biodiapers Signs Agreement with Sicam
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Augmedics Debuts New Features, Indications for xvision Platform
    Artelon Closes $20M Series B Funding
    Orthofix Unveils Seven-Year Outcome Data for M6-C Artificial Cervical Disc
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    DIC Acquires Photoresist Polymers Manufacturer PCAS Canada
    Arkema Collaborates with Habitat for Humanity Philadelphia
    Vitesco Technologies, onsemi Sign SiC Long-Term Supply Agreement

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login