• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Two Clinical Case Reports Demonstrate Trend Accuracy of Masimo Noninvasive and Continuous Hemoglobin and Illustrates Its Use as an Effective Tool for Blood Conservation

Two Clinical Case Reports Demonstrate Trend Accuracy of Masimo Noninvasive and Continuous Hemoglobin and Illustrates Its Use as an Effective Tool for Blood Conservation

October 1, 2010 By MassDevice

PRESS RELEASE

Masimo (NSDQ:MASI) announced today that two new clinical case reports presented at the Society for the Advancement of Blood Management (SABM) Annual Meeting demonstrate that Masimo noninvasive and continuous hemoglobin (SpHb) provides measurements as accurate as invasive laboratory blood tests, offering a “new and effective strategy to facilitate blood conservation efforts and minimize unnecessary transfusions in the intensive care unit (ICU).”  The case report also states that SpHb monitoring contains none of the drawbacks of traditional blood analysis that can impact clinical decisions.

According to Aryeh Shander, MD, Executive Medical Director at the Institute for Patient Blood Management & Bloodless Medicine Surgery and Chief of Anesthesiology and Critical Care Medicine at Englewood Hospital & Medical Center, “In continuing to recognize the negative impact of red blood cell (RBC) transfusion on the critically-ill, our threshold for transfusion is increasing.  Masimo noninvasive and continuous hemoglobin technology offers two significant advantages: the first is the ability to continuously monitor hemoglobin (especially at low levels) as we treat the patient with modalities other than transfusion and the second is the ability to avoid or reduce development of anemia in the ICU patients due to repeated blood draws that cause and aggravate anemia as noninvasive hemoglobin measurement eliminates the need for repeated blood draws in anemic patients.”  

In the first case report presented, researchers at the Englewood Hospital and Medical Center (EHMC) in New Jersey and Mt. Sinai School of Medicine in New York tracked the performance of Masimo SpHb in a severely anemic patient over the course of four days in the ICU.  In comparing SpHb with invasive hemoglobin measurements (tHb), researchers found high correlation with a SpHb bias of 1.26 g/dL and standard deviation of 0.43 g/dL.  Researchers noted that SpHb measurements (ranging from 4.9 to 11.2 g/dL) “exhibited a consistent trend compared to the changes in laboratory hemoglobin measurements” (between 5.2 to 8.1g/dL) over the four-day period, concluding that “the ability to continuously monitor hemoglobin noninvasively may offer a new and effective strategy to facilitate blood conservation efforts and minimize unnecessary blood transfusions in the ICU.”(1)  

In the second case report presented, researchers at Mayo Clinic in Jacksonville, Florida tracked the performance of Masimo SpHb in a patient undergoing high blood loss liver transplantation surgery.  Comparing SpHb with invasive hemoglobin measurements (tHb) led researchers to conclude that Masimo SpHb measurements compared “favorably with the laboratory measured values over a range of 6-12 g/dL.” Researchers also noted the unique advantages of SpHb monitoring in that it provides “results faster and as an instantaneous readout” while the “stored data is easily retrievable enabling post-procedure processing.”  Dr. Klaus Torp, lead researcher and Anesthesiologist at Mayo Clinic, recognizes the importance and impact of SpHb monitoring in surgical patients, offering that “During massive hemorrhage, having the ability to monitor hemoglobin levels in real-time may enable the anesthesiologist to assess and match transfusion needs fast—allowing one to rapidly optimize oxygen delivery, intravascular volume, and avoid over-transfusion.”(2)

Traditional blood analysis has many drawbacks, including complexity, time-consuming turnaround times that can impact clinical decisions, and blood loss due to invasive blood draws that have been found to contribute substantially to the anemic conditions that commonly occur in critically-ill patients—thereby increasing transfusion rates.  Published studies have shown that transfusion of just one or two units of blood significantly increases infection, pneumonia, sepsis, and mortality after surgery.(3,4) These studies also suggest that transfusions and their associated risks could be “largely avoided” through implementation of better blood management techniques and “more appropriate indicators” for transfusions. The ability to continuously and noninvasively trend a patient’s hemoglobin level with Masimo SpHb offers a breakthrough in blood management with the potential to improve clinical decision-making, reduce patient exposure to unnecessary blood transfusions, and preserve precious resources.

“These two case reports clearly demonstrate that Masimo SpHb provides the best available opportunity for reducing and/or eliminating anemia and transfusion related risks in surgical patients in the easiest and quickest possible way,” stated Dr. Shander.

SpHb is available as part of the Masimo rainbow SET platform—the first-and-only technology to noninvasively and continuously measure total hemoglobin (SpHb), oxygen content (SpOC™), carboxyhemoglobin (SpCO), methemoglobin (SpMet), Pleth Variability Index (PVI), and acoustic respiration rate (RRaTM), in addition to the ‘gold-standard’ Measure-Through Motion and Low Perfusion performance of Masimo SET oxyhemoglobin (SpO2), perfusion index (PI), and pulse rate (PR).  

About Masimo (www.masimo.com)

Masimo (NSDQ:MASI) develops innovative 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 demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion.  In 2005, Masimo introduced rainbow Pulse CO-Oximetry™, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb), oxygen content (SpOC™), carboxyhemoglobin (SpCO), methemoglobin (SpMet), and Pleth Variability Index (PVI), in addition to SpO2, pulse rate, and perfusion index (PI).  In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™).  Masimo’s rainbow platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.  Founded in 1989, Masimo has the mission of “Improving Patient Outcome and Reducing Cost of Care … by Taking Noninvasive Monitoring to New Sites and Applications.”

Filed Under: Uncategorized

In case you missed it

  • Shareholder lawsuit over BD’s Alaris pumps recall moves forward
  • Dyad Medical wins FDA clearance for cardiac imaging platform Echo:Prio
  • Outset Medical wins national VA contract
  • Inspire Medical Systems appoints former Zimmer Biomet exec as VP of investor relations
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Acutus Medical ticks up on revenue beat, missed EPS in Q2 results
  • ResMed expects steady growth over the next year
  • Ambu is letting go of 200 employees
  • Medtronic has Class I recall for low-shock risk in ICDs
  • Titan Medical to start manufacturing Enos systems later this year
  • ZimVie sales down more than 11% in Q2 as it streamlines after spinoff
  • Cardinal Health’s CFO to move up to corner office
  • Levita Magnetics raises $26M for Magnetic-Assisted Robotic Surgery platform
  • Data supports use of Channel Medsystems Cerene cryotherapy
  • The 10 largest orthopedic device companies in the world
  • Nanopath raises $10M Series A for women’s health diagnostics
  • Avenda wins FDA IDE nod for AI-enabled prostate cancer therapy

RSS From Medical Design & Outsourcing

  • TE Connectivity opens global medical device prototyping center in Ireland
    TE Connectivity (NYSE:TEL) today announced it opened its global Propelus Prototype Center for medical devices in Galway, Ireland. The $5 million rapid prototyping center was built into its existing manufacturing site in Galway and directly connects TE engineers with customers to reduce development time and increase speed to market for lifesaving and life-improving medical devices. Propelus… […]
  • Contract manufacturer Minnetronix Medical launches its first in-house product, MindsEye
    Minnetronix Medical has launched MindsEye, making it the first medical device that the contract developer and manufacturer has conceived and commercialized. St. Paul-based Minnetronix Medical’s MindsEye is the first expandable brain access port on the market. The FDA cleared the device under the 510(k) pathway in August 2020. The minimally invasive device gives neurosurgeons deep… […]
  • What’s next for Jennifer Fried after leaving Explorer Surgical?
    Explorer Surgical co-founder Jennifer Fried has resigned from the company after selling it to Global Healthcare Exchange in October. Fried announced her departure last week on LinkedIn, saying she’s preparing for her next professional chapter. “It’s bittersweet — I’m so proud of everything our team has built and accomplished,” Fried wrote. “The time has flown… […]
  • The 24 best medical device innovations of 2022
    The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.… […]
  • FDA issues new COVID-19 testing guidance to avoid false negatives
    COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers. The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies… […]
  • Confluent Medical expands Costa Rica manufacturing footprint for nitinol, complex catheter production
    Confluent Medical Technologies this week announced the opening of its new addition to its Costa Rica manufacturing facility. The expansion adds 66,000 sq. ft to its large-scale manufacturing center of excellence in Alajuela, Costa Rica to expand Confluent’s capacity for nitinol component processing and complex catheter manufacturing. “Confluent has experienced consistent and strong growth in… […]
  • FDA’s breakthrough medical device designations tally nears 700
    Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases. According to recent metrics published by FDA, the agency has issued a total of… […]
  • Lifecore Biomedical’s owner plans to go all-in on contract development and manufacturing
    Lifecore Biomedical parent company Landec Corp. (Nasdaq:LNDC) plans to take the subsidiary’s name, leadership and headquarters as its own and sell off food businesses to focus on contract development and manufacturing. Santa Maria, California-based Landec said it will rename itself as Lifecore Biomedical “in the near future” and change its Nasdaq ticker to LFCR. Landec… […]
  • COVID-19 immunity test developers at MIT seek diagnostic manufacturer
    MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA. The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample,… […]
  • GE Healthcare picks AI imaging startups for inaugural Edison Accelerator
    GE Healthcare and Nex Cubed have selected seven companies focused on artificial-intelligence-augmented medical imaging for the first cohort of the Edison Accelerator in Canada. The companies will be matched with mentors and test their technologies with GE’s new Edison Digital Health Platform over the next three months. The program will end with innovation showcase presentations… […]
  • Boston Scientific whistleblower launches corruption investigation
    Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam. Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission. “In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam.… […]

Leave a Reply

You must be logged in to post a comment.

Primary Sidebar

DeviceTalks Weekly

August 12, 2022
DTW – Medtronic’s Mauri brings years of patient care to top clinical, regulatory, scientific post
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy