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New Clinical Study Shows Masimo SET® Significantly Outperforms Other New Generation Pulse Oximeters in the Monitoring of Sick Newborns
Clinical Study Shows Masimo SET Is an Order of Magnitude Better in Rejecting False Alarms and Detecting True Alarms Compared To N-395, MARS, & Viridia Rev. C.0
Washington D.C., December 10, 2001 - William W. Hay, Jr. MD, Donna J. Rodden, RN, BSN, Shannon M. Collins, RN, BSN, Diane L. Melara, RN, BSN, Kathy A. Hale, RN, BSN, and Lucy M. Fashaw RN, BSN from the Neonatal Clinical Research Center, Department of Pediatrics, University of Colorado Health Sciences Center, Denver, Colorado, reported their clinical study results of evaluating the N-200 and new generation pulse oximeters as compared with Masimo SET pulse oximetry technology in the Neonatal Intensive Care Unit (NICU) at the 2001 Hot Topics in Neonatology meeting. The purpose of the study was to determine the impact of Masimo SET pulse oximetry technology in addressing two major concerns for clinicians in the NICU: the incidence of false alarms and the ability to detect true hypoxemia (dangerously low oxygen saturation) and bradycardia (dangerously low pulse rate). The study reported that the Masimo SET pulse oximeter had over 90% fewer false alarms and data drop outs than the Nellcor N-395, Novametrix MARS, and Philips Viridia pulse oximeters.
A total of 33 non-sedated NICU infants, between 900 to 2710 grams who were on supplemental oxygen and/or mechanical ventilation were studied. All data were acquired via a computer operated by trained neonatal clinical research nurses, and the simultaneous performance of N-200 and Masimo SET and four new generation pulse oximeters (Masimo SET, Nellcor N-395, Novametrix MARS, and Philips/Agilent/HP Viridia 24C rev C.0) were compared. The Masimo SET technology not only displayed dramatically fewer false alarms and false bradycardias, but also displayed significantly better performance in detecting true hypoxemias and bradycardias, while showing zero instances of frozen pulse rate. Masimo SET had over 90% less false alarms than all other pulse oximeters, including the N-200, N-395, MARS and Viridia. Masimo SET also detected 90% more true alarms and true changes in physiology than all the other pulse oximeter technologies, including all of the new generation pulse oximeters, claiming equivalent performance to Masimo SET. The new generation results reported by Dr. Hay's team are presented in the following table:
The Researchers concluded, "Masimo SET pulse oximetry recorded markedly fewer false SpO2 and PR alarms and identified more true hypoxic and bradycardic events than either conventional or other new generation pulse oximeters. This reduced frequency of alarms should improve the accuracy of oxygen administration to newborns." The authors further stated, "Routine use of Masimo SET pulse oximetry in the NICU should improve clinician confidence in this parameter leading to more accurate administration of oxygen with possible reductions in hypoxic (e.g., pulmonary hypertension) and hyperoxic (e.g., retinopathy of prematurity (ROP)) pathology."
"In 1996, 1997, and 1998, when Kontron, NEC Medical (now part of GE Medical) and Datascope, first introduced Masimo SET in Europe, Asia, and America, respectively, a breakthrough in medicine was made, finally pulse oximetry could be relied upon to report accurate oxygen saturation and pulse rate. Since then, more than 35 companies are providing Masimo SET pulse oximetry in myriad of configurations to the clinical community; and clinicians, patients and families of patients are benefiting from their offerings, stated Kevin Mosher, Vice President of Masimo.
Joe E. Kiani, Chief Executive Officer of Masimo added "Given that the standards for pulse oximetry have changed with the advent of Masimo SET, a few companies using ideas from Masimo, have introduced products to compete with Masimo SET. To promote their products, these companies have produced internal, and simulated studies which purportedly show their products are as good as Masimo SET. Unfortunately for clinicians and patients, as can be seen from this and other independent clinical studies, other pulse oximeter technologies not only continue to report high levels of false alarms, but miss many true critical alarms, which both have the potential to endanger patients".
Clinical Studies Show Dramatic Cost Reduction & Clinician Satisfaction Following Conversion to Masimo SET® Pulse Oximetry
Studies Conducted at St. Vincent Hospital Reveals 58% Reduction in Sensor Consumption
San Antonio, Texas, December 3, 2001 – Tom Noblet, RRT, Neonatal Intensive Care Unit from St. Vincent Hospital, Indianapolis, Indiana, at the 2001 Annual American Association of Respiratory Care conference presented results of studies investigating the financial implications of utilizing Masimo SET pulse oximetry technology and its clinical impact. The studies found that Masimo sensors lasted 11.5 days on average, which is 2.4 times longer than the conventional pulse oximetry sensors they were using. The study also reported a remarkable 58% reduction in sensor consumption, which was attributed to the increased durability of the Masimo sensors and the ease of acquiring initial oximetry readings with Masimo SET technology.
St Vincent Hospital, a 600+ bed hospital, including a 39-bed, level III Neonatal ICU (NICU), converted the entire hospital to Masimo SET one year ago. The conversion was completed with Masimo’s Radical pulse oximeter, which, in addition to satisfying the hospital’s needs for single parameter and handheld units, was also able to upgrade the existing multi-parameter monitors.
Mr. Noblet evaluated the number of sensors utilized per patient admission for a three-month period of time, and compared the results to the three-month period prior to conversion. Mr. Noblet also surveyed the staff (RNs, RRTs, and MDs) to determine the clinical impact of the Masimo SET technology.
When surveyed, 91% of the staff reported they had a greater sense of patient safety since changing to Masimo SET pulse oximetry. 96% of the staff reported that changing to Masimo SET pulse oximetry has resulted in less handling of infants to “fix or adjust” sensors in order to obtain reliable saturation values, and 83% indicated that if they transferred to another nursing unit, they would encourage them to use Masimo SET pulse oximetry. Mr. Noblet concluded, “After having used Masimo SET pulse oximetry in our NICU, our staff perceives greater patient safety and staff satisfaction from this new technology. In our experience, Masimo oximetry sensors significantly reduce the cost of oximetry monitoring. We attribute this to their increased durability and ease of acquiring initial oximetry readings.”
Two New Clinical Studies Demonstrate Improved Patient Care Due to Advanced Accuracy of Masimo SET® Pulse Oximetry
Faster Patient Weaning and Fewer Blood Gas Measurements Reported in University of Virginia Health System Studies
San Antonio, Texas, December 2, 2001 – Stephanie K. Rostow, RRT, and Charles G. Durbin, Jr., MD, Professor of Anesthesiology and Surgery, University of Virginia Health System, Charlottesville, Virginia, at the 2001 Annual American Association of Respiratory Care conference presented results from two studies that investigated changes in caregiver behavior using next-generation, Masimo SET pulse oximetry technology. The studies found that caregivers weaned patients 68% faster, while administering 34% fewer arterial blood gas draws (ABGs), when monitoring with the Masimo SET pulse oximeter as compared with the conventional pulse oximeter.
Dr. Durbin and Miss Rostow conducted the studies on 86 adult patients following coronary artery bypass grafts (CABG) surgery. On arrival in the intensive care unit (ICU), both a Masimo SET pulse oximeter and a conventional pulse oximeter were attached to the same hand of each patient. Caregivers were only permitted to see the output of one of the pulse oximeter monitors on a computer display at any given time, and their behavior was recorded throughout the duration of the studies. The first study focused on the accuracy of each of the pulse oximeters by comparing the actual results of each ABG (SaO2) to the arterial saturation as reported by the pulse oximeter (SpO2). The second study focused on caregiver behavior resulting from their confidence in the oximeter readings, and measured by the number of ABGs they administered and patient weaning time from high FiO2 (administered oxygen).
Comparisons to the actual ABG saturations (SaO2) revealed that Masimo SET was 35% more accurate than the conventional pulse oximeter. Additionally, the conventional pulse oximeter demonstrated a bias greater than 5% of the actual ABG five times more often than Masimo SET. The differences in caregiver behavior were equally dramatic. When relying upon the Masimo SET pulse oximeter, patients were weaned from high FiO2 in 32% of the conventional pulse oximeter weaning time, and received 34% fewer ABGs. The studies’ authors concluded, “This study shows that clinicians learned to identify better monitoring technology. This experimental design (randomized patients and blinded clinicians [permitted to see one oximeter at a time]) is a powerful method to evaluate the impact of new technology.”
The Huntington’s Disease Society of America Honors CEO of Masimo with Distinguished Leadership Award
Irvine, California November 19, 2001 – Joe E. Kiani, President & CEO of Masimo Corporation, was presented with the Huntington’s Disease Society of America’s (HDSA) Distinguished Leadership Award at the First Annual HDSA Orange County Celebration of Hope Dinner last week. The HDSA Distinguished Leadership Award is a nationally recognized award associated with the Celebration of Hope Dinners, which benefit HDSA Centers of Excellence in cities around the country. The award is presented to individuals who have had a positive impact in their communities, and for the significant contributions they have made in their chosen fields.
Mr. Kiani was recognized for his accomplishments in founding Masimo Corporation, the innovator of Masimo SET – Signal Extraction Technology – which is used in the healthcare field as the premier noninvasive patient monitoring technology. Since its worldwide market release in 1998, Masimo SET has emerged as the preeminent pulse oximetry (measuring a patient’s arterial blood oxygen saturation) technology, particularly under the most challenging conditions of patient motion and low perfusion (low blood flow). Other recipients of the Distinguished Leadership Award included:
"Huntington’s Disease is a degenerative, fatal genetic disorder that can absolutely devastate families who are affected by it," said Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. "I am honored to receive the Distinguished Leadership Award, but, more importantly, I am hopeful that events such as the Celebration of Hope dinners, will serve to bring awareness and support in the fight to end Huntington’s Disease."
Huntington’s Disease (HD), named for Dr. George Huntington who first discovered the disease in 1872, is a fatal and degenerative brain disorder for which there is, at present, no effective treatment or cure. HD, which is passed down to 50% of the children of a parent having the disorder, slowly diminishes the affected individual’s ability to walk, talk and reason. The Huntington’s Disease Society of America is dedicated to providing support and education to the families affected by this life-altering illness, and to ultimately finding a cure. HDSA Centers of Excellence provide clinical care, counseling, referrals and education for individuals with HD and their families. HDSA Centers of Excellence are supported through Celebration of Hope events and through the generosity of the community and HD family and friends.
New Patient Monitoring Technology from GE Provides Clinicians with Critical, Uninterrupted Flow of Patient Information for More Accurate Decision Making
Technology Combines Major Vital Signs Monitoring into Single Device
Milwaukee, Wis. (November 12, 2001) - Now clinicians have access to a single bedside monitoring device that monitors critical patient vital signs using the most advanced technology available today.
The technology, introduced by GE Medical Systems Information Technologies, for the first time combines "best-in-class technologies", including ECG, respiration, blood pressure, temperature, noninvasive blood pressure and pulse oximetry together into a single device for complete patient bedside monitoring in intensive care, critical care, the operating room, and anywhere in the hospital during transport.
The combined device, called TRAM® Multiparameter Module, provides clinicians with more complete, accurate information, so they can make better, timely decisions for patients. It includes advanced pulse oximetry technology from Masimo, called Masimo SET®, which can help clinicians treat patients by significantly reducing false alarms, and more accurately measuring patients with poor perfusion or weak pulses.
According to Diane Penzkowski, clinical manager for the cardiac care unit at St. Mary's Medical Center, Racine, Wis., the new TRAM module will have complete, accessible patient data at the bedside and will improve quality of care in her department. "The small, lightweight module will come in handy for continuous monitoring during transport situations," said Penzkowski.
The TRAM module was developed to meet these workflow and timely decision-making needs of the healthcare community, according to Kevin King, vice president of Clinical Systems at GE Medical Systems Information Technologies. "Since the beginning of computerized vital signs monitoring, clinical decisions have been made using up to five different monitoring devices in a single patient room, all extracting different data from the patient, which then requires the merger and analysis of this information to make a confident clinical decision," said King.
"Now these different vital signs 'best in class' technologies are integrated into a single, advanced acquisition device, which is the first step in the ability to provide 'real-time', continuous data to clinicians. Together with communications networks and information systems, this device will enable clinicians to enhance their workflow and clinical needs, helping them make the most informed and timely decisions for patients."
According to King, the TRAM Multiparameter Module enhances GE's suite of gold standard cardiac algorithms in its monitoring systems. The complete feature set for the TRAM Multiparameter Module includes:
The compact, flexible TRAM module can be used with new or existing SOLAR® patient monitors and the Prucka MAC®-Lab cardiac cath lab physiological monitoring system. The modules also serve as intra-hospital transport monitors when combined with the Smartpac® display, which eliminates the need to reconnect patient cables, providing simultaneous, uninterrupted monitoring during transport.
GE Medical Systems Information Technologies provides healthcare systems with advanced software and technologies to improve their clinical performance. The Company's expertise spans the areas of cardiology, patient monitoring, image management, clinical communications, clinical information systems and Six Sigma-based management tools to enable a real-time, integrated electronic medical record. GE Medical Systems Information Technologies is a business of GE Medical Systems, an $8 billion global leader in medical imaging and technology. Additional information about GE Medical Systems can be found at www.gemedicalsystems.com.
The University of Medicine and Dentistry of New Jersey's University Hospital Completes Hospital-Wide Conversion to Masimo SET Pulse Oximetry
Hospital Cites Performance and Cost Reduction as Key Benefits
Irvine, CA, November 8, 2001 - Masimo Corporation, the innovator of Signal Extraction pulse oximetry technology, announced the successful full-house conversion of The University of Medicine and Dentistry of New Jersey's (UMDNJ) University Hospital, to Masimo SET® pulse oximetry technology. Key factors in the conversion were Masimo SET's superior clinical performance versus conventional pulse oximetry, its ability to serve as a turnkey solution, and its ability to reduce costs.
Peter Fine, M.D., Director of Equipment for Anesthesiology, was looking for a pulse oximetry technology that provided more accurate readings and less false alarms, particularly in situations of patient motion and low perfusion (low blood flow to the sensor site). "I found out Protocol, Datascope and GE (Medical Systems Information Technologies), all were incorporating the [Masimo SET] technology, and that made the difference," Dr. Fine said. Masimo's RadicalT Signal Extraction pulse oximeter, which serves as a standalone pulse oximeter, a handheld pulse oximeter, or, with Masimo's unique SatShareT interface, as a simple, inexpensive means of upgrading a hospital's existing multi-parameter monitors, rounded out the hospital-wide conversion.
UMDNJ indicated that physicians no longer "second guess" their pulse oximeter readings since the conversion to Masimo SET Technology. More important, Dr. Fine points out that the physician is completely focused on the patient, and not concerned with malfunctioning equipment. "Recently, we were working on a premature infant who had a very difficult airway. The anesthesiologists couldn't hear her breathing. We spent a lot of time working to secure the airway. It was amazing, the one thing we never thought about was the pulse oximeter not working. We could finally concentrate on what was going on clinically," said Dr. Fine.
UMDNJ's University Hospital has found an additional benefit with Masimo SET pulse oximetry; reduced sensor usage and cost savings. Carolyn Ricks, Value Analysis Facilitator at UMDNJ, stated, "Sensor utilization will be significantly reduced because of the quality of the sensors and the speed at which the sensor extracts the signal." Miss Ricks points out that UMDNJ University Hospital spent a half a million dollars on sensors last year. Dr. Fine commented, "We were having a dramatic problem with disposable sensors where we would have to place two, three, four times per patient, and still not acquire a reliable signal. Since switching to Masimo sensors, physicians at UMDNJ need only apply one sensor to get a reliable reading." Based on Miss Ricks' research, the hospital should achieve a $180,000 savings in sensors in the first year alone.
The conversion was a great success, and the hospital was as impressed with the support as it was with the technology. "Masimo has brought a great customer service value to us and we definitely view Masimo as partners, not just a vendor," Miss Ricks commented. Added Brian X. Weaver, BS, RRT, RPFT, "In addition to providing a superior pulse oximetry product, Masimo has also demonstrated a keen interest in listening to and, more importantly, responding to their customer's inputs. During the conversion to Masimo SET at UMDNJ, I made two suggestions I thought might improve their sensors and cables. To my surprise, one suggestion has already shown up in their product, and the other is due out soon! It's no wonder they're delivering products and technology that so closely meets the needs of their customers."
"To see the adoption of our technology by a prominent teaching hospital such as UMDNJ is truly rewarding," stated Kevin Mosher, Marketing Executive at Masimo Corporation. "Going through such a process is certainly a challenging endeavor, yet UMDNJ's dedicated staff was determined to provide the best care possible and stayed with the process. We are thankful that we have been able to help UMDNJ to continue its mission of providing the optimum in patient care.
As the core teaching facility of the UMDNJ - New Jersey Medical School, The University Hospital is the center of referral for many of New Jersey's most advanced medical services and specialty programs. The hospital is staffed by 300 full-time attending physicians who are also faculty members of the New Jersey Medical School. The University has more than 19,000 admissions, 2,700 births, and 215,000 outpatient visits annually. University Hospital incorporates a formal review process, headed by a Value Analysis Coordinator, that evaluates any new equipment brought into the hospital. The review process spans all clinical departments, purchasing and administration, and places particular emphasis on those products that improve patient care while containing or reducing costs.
Audie Lewis Consulting Releases Independent Quality/Benefits Audit on Masimo SET Pulse Oximetry
Masimo receives the highest Audie Lewis customer satisfaction rating ever, 9.75
Irvine, CA, October 24, 2001 - Audie Lewis Consulting, Inc, a consulting organization serving hospitals, published its audit report this week on Masimo Signal Extraction Technology, Masimo SET. The audit report, which concluded that none of the other pulse oximetry technologies matched the quality and clinical benefits of Masimo SET, provided an overall assessment of "Outstanding." Masimo also received high grades for Masimo SET's cost reduction impact to hospitals, and the highest rating ever for customer satisfaction.
Audie Lewis Consulting's independent audit assessed Masimo SET technology and its claims of improving care, reducing medical errors and reducing cost of care, as well as the company's product offerings, manufacturing capabilities, service quality and overall business environment. The analysis involved a comprehensive look into the pulse oximetry marketplace and Masimo SET technology, including its comparison to all other available pulse oximetry technologies, and its impact on patient welfare and healthcare costs. The audit was conducted over several months.
The Audie Lewis audit not only concluded that Masimo's claims of product superiority for patients with motion and low perfusion were thoroughly tested and validated, but further stated that "Audie Lewis Consulting believes any person and/or organization can easily validate Masimo's claims to have created a pulse oximetry technology that is far superior to any existing technology in the marketplace." The study also determined that Masimo's technology contributed to what it called "Clinical Practice/Treatment Shifts." Specifically, the audit found users of Masimo SET pulse oximetry technology realized a lower rate of arterial blood gas draws (ABGs), which are often used to validate the readings of their pulse oximeters. The study further showed a decline in the administration of O2 due to a more accurate understanding of the patient's true saturation levels, as well as patients being weaned from the ventilator more quickly, thus reducing length of stay. Audie Lewis also found a dramatic reduction in sensor usage amongst Masimo SET users, citing the durability of Masimo's sensors, and reporting that clinicians no longer needed to use three or four sensors on a patient in order to get a reliable reading. The audit validated Masimo's claims of reducing healthcare costs while improving patient care, stating, "Masimo's technology reduces sensor usage and eliminates the need for wasteful practices. Masimo SET is raising the standard of care for patients.a positive impact on patient safety is especially prevalent within the higher risk categories such as those in cardiac treatment areas, neonatal intensive care units, respiratory therapy and similar at-risk patients."
"Mr. Audie Lewis is to hospital process improvement as Dr. Edward Deming was to manufacturing process improvement," stated Joe E. Kiani, Chief Executive Officer of Masimo Corp. "Similar to what Dr. Deming has done for major manufacturing companies, Mr. Lewis offers realizable and sound advice on how to turn unprofitable hospitals and overworked hospital staff into profitable hospitals with efficient clinical staffs focused on quality of patient care. During the Audie Lewis audit period, we recognized the value Audie Lewis brings to hospitals that are trying to reach profitability while improving their level of care. I expect Mr. Lewis will be the recipient of many accolades and much appreciation, not only for what he has done to date, but for what he will continue to do for hospitals and patient care with his subtle but profound techniques for reducing hospital cost while maintaining, if not improving, the level of care."
"For us at Masimo, the most gratifying part of this audit was to hear what some of our customers told Audie Lewis Consulting: 'The learning curve is well worth the transition'; 'Functions best and support is excellent with Masimo'; 'Called company with a problem at 4:30pm yesterday, 10:30 this morning had a replacement unit from Masimo-they solved the problem immediately'; 'Step-down-unit - it is like walking into a library - no more noisy alarms'. we thank our customers and our dedicated team at Masimo," concluded Mr. Kiani.
Audie Lewis Consulting, Inc. is a privately held research and consulting firm that exists to help health care organizations solve out of control operating costs so that the quality of patient care can be improved to its maximum extent. To this end, Audie Lewis Consulting develops Lean Logistics business improvement methodologies and best-in-class technology integration practices that promote profitability and sustainability for the industry. The firm provides a wide range of consulting products and services, critical investigative research, organizational/executive training and similar supportive roles nationally and internationally. For more information about this company and their current business operations visit them on the world-wide-web at www.audielewisconsulting.com.
Audie Lewis' latest book, Streamlining Health Care Operations: How Lean Logistics Can Transform Health Care Organizations, published by Jossey-Bass and the American Hospital Association (AHA) Press (May 2001) addresses methods, processes and strategies for improving the operational performance of health care organizations so that they can maximize revenues and drastically reduce operating costs. It is a highly practical guide to cutting costs and improving performance and has been endorsed by some of the most respected names and organizations in the industry. For more information visit www.josseybass.com.
Copies of the Audie Lewis Consulting audit of Masimo Corporation can be obtained by e-mailing firstname.lastname@example.org, or by writing Audie Lewis Consulting, Inc. 11500 Villa Grand, Suite 313, Fort Myers, FL 33909. The cost of an individual report is $100.
Masimo SET Delivers Unprecedented Accuracy & Reliability Under Challenging Conditions
New Orleans, LA, October 16, 2001, Two independent studies validating Masimo SET as the performance leader in pulse oximetry were presented during a special lecture series on technology, monitoring and equipment, and a Refresher Lecture titled "Advances in Oxygen Monitoring", at the Annual meeting of the American Society of Anesthesiologists (ASA) in New Orleans. Both studies tested the performance of multiple oximeters claiming accuracy during motion and low perfusion on volunteers during normoxia (room air) and hypoxia (low oxygenation). Although the studies were done at different research centers, the results of the studies were consistent, demonstrating that only Masimo SET delivered on its claims of superior performance for reliability, sensitivity and specificity during challenging conditions.
Steven J. Barker, PhD, MD, Professor and Head of Anesthesiology at the University of Arizona College of Medicine, presented results from their latest pulse oximetry performance study comparing the performance of the latest models of pulse oximeters that claim to be motion tolerant. In the study, entitled "The Performance of Six 'Motion-Resistant' Pulse Oximeters during Motion, Hypoxemia and Low Perfusion in Volunteers," thirty healthy volunteers breathed hypoxic gas mixtures while undergoing challenging and repeatable persistent motions. The room temperature was held at 15-18 degrees Celsius throughout the study in order to reduce peripheral perfusion and better simulate actual patients with low perfusion. Sensitivity, the ability to detect true alarms; specificity, the ability to reject false alarms; and drop-out, the time the monitor would not operate, were analyzed for all monitors. The Masimo SET pulse oximeter displayed the best overall performance with a sensitivity of 99%, a specificity of 97% and no incidence of dropout. In contrast, the Nellcor N395 showed a sensitivity of 70%, specificity of 73% and a dropout of 4%, while the Novametrix MARS showed a sensitivity of 40% and a specificity of 42% and a dropout of 2.4%. The other pulse oximeters tested also had lower scores for sensitivity and specificity as compared with the Masimo SET unit.
Nitin Shah, MD, Sara Clack, RA, Trang Hoang, MD, and Bhavna Gupta, MD from the Department of Anesthesiology, University of California at Irvine conducted a second study entitled, "A Comparison of Four Major Brands of Pulse Oximeters with Masimo SET Pulse Oximetry during Motion and Low Perfusion under Normoxic and Hypoxic Conditions in Human Volunteers." In a room that was cooled to a temperature of 16 - 18 degrees Celsius to reduce peripheral perfusion, simulating sick patients with low perfusion, adult volunteers breathed hypoxic gas mixtures while undergoing challenging and repeatable persistent motions. Again, the Masimo SET pulse oximeter performed the best of all five pulse oximeters tested, with a sensitivity of 96% and a specificity of 87%. In contrast, the Nellcor N395 had a sensitivity of 54% and a specificity of 67%, while the Novametrix MARS showed a sensitivity of 18% and a specificity of 29%. The other pulse oximeters tested also had lower scores for sensitivity and specificity as compared with the Masimo SET unit. Dr. Shah's results appear to be consistent with those of Barker, above.
Clinical Studies Comparing Leading Pulse Oximetry Technologies Find Masimo SET Has Best Performance
Masimo SET outperforms other technologies in three studies investigating the reliability of pulse oximetry under challenging conditions
New Orleans, LA, October 15, 2001, Three studies validating Masimo SET as the performance leader in pulse oximetry were presented during a special lecture series on technology, monitoring and equipment at the Annual Meeting of the American Society of Anesthesiologists (ASA) in New Orleans. Two of the studies compared Masimo SET against conventional pulse oximeters under a variety of challenging conditions including motion, low perfusion and hypothermic cardiopulmonary bypass (CPB). A third study investigated recovery times for the accurate display of SpO2 and pulse rate after motion induced failure of pulse oximeters. In all cases, Masimo SET dramatically outperformed all other conventional pulse oximeters in a clinically significant manner.
A team of researchers led by Nitin Shah, MD, from the Department of Anesthesiology, University of California at Irvine, presented results from a new study comparing the performance of five pulse oximeters that claim to be motion and low perfusion tolerant on both oxygen saturation (SpO2) and pulse rate. The study concludes that Masimo SET® performed the best of all the models tested in terms of accuracy and reliability during patient motion and low perfusion conditions. Dr Shah’s group also presented a second study investigating the recovery time for the accurate display of SpO2 and pulse rate after motion induced failure of pulse oximeters during conditions of low perfusion. Five pulse oximeters were tested for performance, and the study’s authors again concluded that Masimo SET outperformed all other models for both recovery time and failure rates.
In both studies conducted at UC, Irvine, the Masimo SET Radical was compared with four “next generation” pulse oximeters, including the Nellcor N-395. Patient motion was performed by a repeatable and scientific protocol, and introduced during normoxia (breathing room air). The authors concluded their analysis demonstrated a statistically significant difference between the performance of the pulse oximeters for both SpO2 and pulse rate, and Masimo SET outperformed all systems tested. In the second study, Masimo SET demonstrated a faster mean recovery time for the accurate display of SpO2 and pulse rate versus all oximeters tested, including a 46% faster recovery time versus the Nellcor N395.
In another study, a group of researchers led by Kazuo Irita, MD, Department of Anesthesiology and Critical Care Medicine, Kyushu University School of Medicine, Fukuoka, Japan, presented a new study comparing the performance of the Masimo SET Radical pulse oximeter and a conventional pulse oximeter during hypothermic cardiopulmonary bypass (CPB). Eighteen patients were studied and the Masimo SET pulse oximeter displayed accurate SpO2 values when the conventional pulse oximeter couldn’t during mild hypothermic CPB, indicating that Masimo SET is more useful for monitoring SpO2 during low perfusion. The authors used the roller pump generated CPB device, which had pulsatility sufficient enough to enable the Masimo SET pulse oximeter to display SpO2 even at extremely low mean arterial blood pressure (MABP).
Kevin Mosher, Marketing Executive of Masimo, commented; “Historically, pulse oximeter measurements have been prone to errors when patients move or are poorly perfused. Masimo innovated Signal Extraction Technology, which allowed for the first time pulse oximeters to be reliable even during motion and low perfusion. Many companies, including Atom, Datascope, GE Medical Systems, and Zoll, have licensed Masimo SET, and are delivering this truly breakthrough technology to their customers. Growing body of clinical evidence, clearly demonstrate that no other company or technology can deliver the superior performance of Masimo SET pulse oximetry, which has been linked to reduced medical errors, improved outcome and reduction in cost of care.”
Metasensors and Masimo Sign License and Development Agreement
Irvine, CA, September 7, 2001 -- Metasensors(tm), Inc., a medical technology company headquartered in Rockville, Maryland, and Masimo Corporation, innovator of motion and low perfusion-tolerant pulse oximetry technology, announced a license and development agreement to incorporate the Masimo Signal Extraction Technology (Masimo SET) with Metasensors' microfluidic technology based products. The combined OEM products will subsequently be licensed by Metasensors and Masimo to leading companies around the world.
Metasensors' cardiac output monitor, the metaCOM, will be the first product to feature both Metasensors' proprietary microfludic technology and Masimo SET pulse oximetry in one unit. One international medical technology company has already licensed the combined offering. "The metaCOM technology measures cardiac output noninvasively using a unique analytical algorithm," stated Will Moore, Chief Executive Officer of Metasensors. "Our noninvasive cardiac output algorithm requires accurate arterial oxygen saturation measurements. We chose Masimo's SET pulse oximetry platform because of its unprecedented fidelity during all conditions, even under motion and low perfusion. The combination of these two premier technologies in one completely noninvasive module represents a major breakthrough for healthcare providers seeking reliable, economical solutions for patient monitoring."
"We are delighted that Metasensors has adopted Masimo SET as their pulse oximetry technology for their breakthrough products based on their microfluidic technology," said Joe E. Kiani, Chief Executive Officer of Masimo. Metasensors' microfluidic monitoring technology represent performance and cost cutting innovation that truly sets its products apart from the competition. We expect that the Metasensors' noninvasive cardiac output monitor, metaCOM, featuring Masimo SET, will help healthcare providers take better care of their patients with an easy to use and reliable cardiac output monitor."
Metasensors designs and develops data analysis OEM modules for patient-monitoring products to be used in critical healthcare applications based on its proprietary microfluidic technology. Metasensors' technology enables real-time, continuous measurement of gas physical properties on a common, application-independent, electronic platform using a single sensor. Metasensors initial products will target markets for noninvasive breath-by-breath monitoring of cardiac output, cardio-pulmonary function, metabolic rate, pulmonary function, anesthesia gas, and respiratory gas, and property compensated flow meters. More information on Metasensors and their products can be found on the company's website at www.metasensors.com.
BITMOS GmbH and Masimo Corporation Announce Licensing Agreement
IRVINE, Calif., Aug. 28 -- German Medical Device manufacturer, BITMOS GmbH (Dusseldorf, Germany) and California medical technology company, Masimo Corporation (Irvine, CA) today announced a purchasing and licensing agreement under which BITMOS will integrate Masimo Signal Extraction pulse oximetry technology into a new line of stand alone pulse oximeters. BITMOS, a well-established manufacturer of medical devices for the European OEM market, plans to launch the new line of pulse oximeters, called the poxy805, in the fourth quarter of 2001. The poxy805, developed around the highly proprietary Masimo SET pulse oximetry platform, will be the first BITMOS-branded medical device targeted to end-users, such as sleep laboratories, clinics and for homecare. BITMOS also plans to integrate Masimo SET into other new products such as the new line of cardiorespiratory monitors in the future
"In designing our new line, we looked at the pulse oximetry technology offered by all pulse oximetry companies that claim to work during motion and low perfusion," stated Dirk Westhues, Chief Executive Officer of BITMOS GmbH. "Our experience is mirrored by the large number of independent clinical studies that found Masimo SET to be dramatically more sensitive, specific and reliable than other pulse oximetry technologies offered by any other vendor. The BITMOS philosophy is to incorporate the very best technology available into our high-end, innovative designs, so Masimo SET was the obvious choice for our new line of pulse oximetry products."
"With this agreement, BITMOS joins other leading patient monitoring system providers from around the world that have licensed Masimo SET pulse oximetry technology to provide the new standard in performance to their customers," stated Joe E. Kiani, Chief Executive Officer of Masimo Corporation. "We are pleased to have BITMOS as a partner to improve patient care by providing healthcare providers with reliable pulse oximetry measurement when it's needed the most."
Masimo Lawsuit Against Nellcor To Continue After Appellate Court Ruling
Irvine, CA, August 13, 2001 - Masimo Corporation today announced that its patent infringement case against Nellcor, a division of Tyco, will now continue at the District Court in California after a stay of proceedings for several months pending an appeal. The recent appellate ruling involves only one of Masimo's six patents asserted against Nellcor's infringing pulse oximeters. "We filed our lawsuit with one in a series of patents related to Masimo SET's breakthrough motion and low perfusion tolerant technology as soon as Nellcor's infringing product appeared in the market in October 1999. We have since added five recently issued patents to the lawsuit. Although we are disappointed with the Appellate court ruling, it only pertains to two claims from one of the six patents. The five new patents in the lawsuit relate to several aspects of Masimo's innovative pulse oximeter signal processing solutions such as self-optimizing filters (e.g., adaptive filters), Kalman filters, and using multiple processing algorithms to find the best solution," stated Joe E. Kiani, Chief Executive Officer of Masimo Corporation.
Mr. Kiani continued, "We have invested more than ten years developing and validating Masimo SET technology, which has revolutionized pulse oximetry. We were the first company to prove that pulse oximetry could work during patient motion and low perfusion conditions, a feat that was considered impossible prior to Masimo SET technology. Although Nellcor's infringing pulse oximeters use some of our technology, in a recent independent study conducted at the University of Arizona, their pulse oximeter falsely alarmed 30 times more than Masimo SET and missed 27% of true hypoxemic events, compared to only 3% missed with Masimo SET."
"We have protected the many innovative aspects of our technology through nearly 200 patents, and we have offered to share our breakthroughs with every company in our industry. Over 35 leading patient monitoring companies have embraced our technology and are providing the true Masimo SET technology performance to their customers, creating a win for everyone, particularly clinicians and their patients. We appreciate the strong support from clinicians and our partners and will continue to move forward to provide the best pulse oximetry for better patient care. Innovation, created by small companies, would stagnate if large companies like Tyco/Nellcor were allowed to infringe on another company's technology. Accordingly, we cannot permit Tyco/Nellcor to infringe on our patents and limit innovation. This behavior would eventually have a negative impact on clinicians and patient care by stagnating technology development. Because of this, we are compelled to aggressively move forward with our patent lawsuit," concluded Mr. Kiani.
Graseby Medical Limited and Masimo Corp. Announce Agreement
Irvine, CA, August 8, 2001 - Graseby Medical Limited (United Kingdom) and Masimo Corporation (Irvine, Calif.) today announced a purchasing and licensing agreement under which Graseby will integrate Masimo Signal Extraction pulse oximetry technology into its future patient monitors. Graseby is a leading manufacturer of medical equipment, including Infusion Pumps, Apnea Monitors and Masimo is a recognized leader in pulse oximetry technology.
Graseby today announced its plans to first include Masimo SET® technology in their new infant monitor, labeled the MR30. The MR30 combines ECG, Respiration and Masimo SET pulse oximetry vital signs monitoring in a compact, portable, cost-effective package that is ideal for monitoring patients in hospital and non-hospital settings. The MR30 is designed to monitor infants at risk of Alternative Life Threatening Events (ALTE's) and Sudden Infant Death Syndrome (SIDS), one of the leading causes of death in infants.
"The measurement of blood oxygenation via pulse oximetry is now thought to be a promising method of detecting apnoea episodes. Even considering how babies tend to move during sleep, we believe that Masimo SET pulse oximetry technology is sensitive and reliable enough to monitor babies at risk of SIDS," stated Chris Hutchison, Managing Director of Graseby. "Masimo SET has been proven to work well during motion and low perfusion. In the home setting parents have to rely on the accuracy of the monitor because immediate action is essential in the event of an apnoea episode. Masimo SET ensures accurate detection of true events while minimising false alarms, which are not only an annoyance for the family, but also could desensitise parents to true alarms."
Joe E. Kiani, President and CEO of Masimo Corporation, stated, "Graseby has chosen Masimo SET as their pulse oximetry platform because of the technology's unprecedented fidelity, sensitivity and specificity. We are happy to be in partnership with Graseby, because they share our commitment to putting patients and customers ahead of all other priorities.
Graseby designs, manufactures and markets Infusion Pumps and Apnea Monitors. Graseby is based in Watford, UK and its products are available worldwide.
New Study Reveals that Masimo SET Pulse Oximetry Facilitates Accelerated Recovery Times and Dramatically Reduced Costs
Glendora, CA, July 19, 2001 - Dilip S. Patel, MD, Medical Director and Rick Rezkalla, Director of Cardiorespiratory, both of Huntington East Valley Hospital in Glendora, CA have released results of an evaluation of Masimo SET pulse oximetry and its effects on oxygen therapy weaning protocols in their facility. Their nine-month evaluation revealed strong evidence of decreased cost and improved outcomes when using Masimo SET pulse oximetry compared to conventional pulse oximetry solutions. Masimo SET Pulse Oximetry resulted in a 40 percent reduction in the total hours of vented oxygen usage; a significant reduction in the number of Arterial Blood Gas (ABG) draws; and a 42% decrease in average length of stay from 5.3 days to 3.1 days.
The respiratory care department at Huntington East Valley Hospital found that, for the first time, they could continuously acquire data on patients who were poorly perfused, combative or frequently in motion. Because results from ABG's were consist with the reading from the Masimo SET pulse oximeters, the RT's grew increasingly confident in the Masimo SET technology. As a result of the improved confidence, the number of costly invasive tests declined and weaning the patient from ventilators and supplemental oxygen became faster. This led to improvement in patient outcomes and facilitation of successful and early discharges. The time for discharge from the hospital after weaning was reduced by nearly 50% and patients reported being more comfortable while in the hospital's care.
"We are delighted with the results of the new protocol because we have significantly reduced costs," commented Dr. Patel. "But an even more important outcome is the better level of care for patients, getting them off ventilators sooner and sending them on the road to recovery." "Respiratory Therapists now are able to make decisions independently, relieving the nursing staff of making numerous phone calls to physicians to report on the patient's condition, ABG results, and to obtain further weaning orders", added Mr. Rezkalla.
"Nine years of clinical research and nearly 50 independent studies have been done on Masimo SET since we first demonstrated that pulse oximetry could indeed work during motion", stated Joe E. Kiani, President and CEO of Masimo Corporation. "Leading researchers in the field of anesthesia, pediatric anesthesia, neonatology, respiratory care, transport, emergency care, and sleep disorders have all concluded that Masimo SET has broken the motion barrier. All independent studies have shown that Masimo SET clearly established a new level of performance by virtually eliminating false alarms and, due to Masimo SET's fidelity, improving the detection of clinically relevant conditions. Masimo's unprecedented performance and reliability has been linked to reduction of latent conditions, which have been linked to medical errors. This latest study by Dr. Patel and his colleagues is very important, because it proves that with Masimo SET pulse oximetry, patient care can be improved while reducing the cost of care and the workload of the clinicians who are in high demand."
Reference: Dilip P, Rezkalla, R., Weaning Protocol Possible with Pulse Oximetry Technology. Advance for Nurses:38(2001)
Two Independent Studies Report that Masimo SET Pulse Oximetry Provides The Highest Sensitivity, Specificity and Fidelity
Chicago, Illinois, June 11, 2001 - Robert Whitman, PhD, Director, Sleep Disorders Laboratory at the University of Kansas Medical Center and Scott Morgan from the University of Arizona, last week presented their research at the 2001 Associated Professional Sleep Society's Annual Meeting in Chicago. Dr. Whitman's research concluded that Masimo SET V3 Technology detected twice the number of significant true hypoxemias as Nellcor's conventional pulse oximetry technology. Dr. Whitman concluded that this was due to Masimo SET's higher signal fidelity, which should lead to improved diagnostic capabilities. Mr. Morgan's research concluded that Masimo SET pulse oximetry should have a significant impact on patient care, particularly where patient motion is likely.
Dr. Whitman's study evaluated the impact of Masimo SET pulse oximetry technology as compared to the Nellcor technology, on profiles of patients undergoing polysomnography. In the data presented, on 58 patients, the researchers demonstrated that Masimo SET detected two times the number of clinically relevant hypoxemias than the Nellcor unit, a conventional pulse oximeter commonly used in the sleep laboratory for assessing arterial oxygen saturation linked to obstructive sleep apnea. Dr. Whitman concluded, "Masimo SET V3 technology has higher signal fidelity relative to actual physiologic changes in saturation than conventional oximetry technology, which should lead to improved diagnostic capabilities".
In a second study conducted together with Steven J. Barker, PhD, MD, Professor and Head of Anesthesiology at University of Arizona, Mr. Morgan presented their two-year pulse oximetry research on the effects of motion and hypoxemia upon the accuracy of 20 pulse oximeters. This is the largest study of its kind. Seventy subjects were tested with random and periodic motions. All of the motions were continuous, which are the most challenging motions and the type that predominantly causes false alarms in the clinical environment. Using a proven motion and low perfusion protocol sufficiently challenging to distinguish the performance of various pulse oximeters, Mr. Morgan and Dr. Barker's research concluded that Masimo SET was by far the most accurate and reliable pulse oximetry technology tested, demonstrating a sensitivity and specificity of 98% and 93% respectively. Dr. Barker concluded, "our results show that the Masimo SET pulse oximeter performs better during motion and low perfusion than the other units tested. This new technology should have a significant impact on patient care, particularly where patient motion is likely."
"Nine years of clinical research and over 40 independent studies have been done on Masimo SET since we first demonstrated that pulse oximetry could indeed work during motion", stated Joe E. Kiani, President and CEO of Masimo Corporation. "Leading researchers in the field of anesthesia, pediatric anesthesia, neonatology, respiratory care, transport, emergency care, and most recently sleep disorder have all concluded that Masimo SET has broken the motion barrier. All independent studies have shown that Masimo SET has clearly established a new level of performance, not only by virtually eliminating false alarms, but also by improving the detection of clinically relevant alarms due to its fidelity. Masimo's unprecedented performance and reliability has been linked to reduction of latent conditions, which have been linked to medical errors. We are proud of our contribution to the medical community and hope that clinicians will be able to use our technology to take better care of their patients."
Masimo SET Performance Improves Detection of Hypoxemia
International Study Presented at Annual American Thoracic Society
San Francisco, California, May 22, 2001 - A leading international physiologist, Ha Trang, PhD, MD, Director of the Pulmonary Laboratory at the Robert Debre Hospital in Paris, France, yesterday presented her department's research at the 2001 American Thoracic Society's Annual Meeting in San Francisco. Dr. Trang's research concluded that Masimo SET pulse oximetry improved the detection of obstructive sleep apnea related hypoxemia.
Obstructive Sleep Apnea (OSA) is a cessation in breathing which can result in death if undetected. Low arterial oxygen saturation or hypoxemia is an early warning of a significant apnea episode. The number of hypoxemic episodes, and the time spent with desaturation during sleep are considered as major indicators for severe OSA. Pulse oximetry is the most common method of measuring hypoxemia but it has been proven to be unreliable due to patient movement and other types of interference.
This study evaluated the impact of Masimo SET pulse oximetry as compared to the most commonly used pulse oximetry technology from Nellcor, the N200, as well as Nellcor's newest technology, the N-395, on the detection of such sleep apnea-related hypoxemias. In the data presented, the researchers demonstrated that Masimo SET detected 35% more hypoxemic events than the Nellcor N-395 and 65% more hypoxemic events than Nellcor's older technology, the N-200. Dr. Trang concluded, "Hypoxic episodes were more frequently detected by Masimo SET than conventional oximeters. Nellcor's failure to identify hypoxemia may be due to its methods of "freezing" in the last reliable value".
The "freezing" referred to by Dr. Trang, relates to Nellcor's Oxismart and Oxismart XL alarm management techniques. Both rely on the monitor to hold alarms for programmed periods of time when interference is detected. Other leading clinicians have also recently reached similar conclusions regarding Nellcor's latest iteration of their Oxismart technology and their alarm management strategy. In a recent study conducted by Dr. Mitchell Goldstein and presented at the Pediatric Research Society meeting in Minneapolis in May 2001, the researchers found entire runs of periodic breathing and true hypoxemic episodes missed using Oxismart XL with SatSeconds, and even warned against its use in those patients at risk for apnea1.
"We are delighted by Dr. Trang's results," stated Joe E. Kiani, President and CEO of Masimo Corporation. "Our job and mission is to make instruments that report true physiology with utmost fidelity. The fact that clinicians are seeing and reporting on the strength and value of Masimo SET and its ability to accurately capture true events is extremely rewarding. False alarms cannot be reduced at the expense of true alarms. Masimo is dedicated to full disclosure of clinical data to empower the clinician to make the most informed decisions on patient care. This is clearly a defining characteristic between Masimo SET and the other technologies which claim accuracy during motion."
Mr. Kiani continued: "The results from Dr. Trang's study parallel those recently presented by Dr. Steven J. Barker, at the Society of Technology in Anesthesia's Annual Meeting held in January 2001. In his independent motion and low perfusion study, involving all the major pulse oximetry providers, Dr. Barker also noted increased levels of missed events in the non-Masimo devices and found Masimo SET performance significantly superior to all other "motion tolerant" pulse oximeters. He concluded that Masimo SET pulse oximetry represents a significant step forward by providing clinicians with more accurate data with which to treat their patients, particularly in clinical settings in which patient motion was likely."
1 Goldstein MR, Martin GI, Sindel BD, Furman GI, Ochikubo C, Yand L. SatSeconds Alarm Management Misses Short Desaturations Common to Periodic Breathing and Infantile Apnea. Pediatric Research 2001;49(4):400A/2296.
AEA Honors Masimo with Innovative Product/Technology Award
Irvine, California May 18, 2001 - Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, was honored by the American Electronics Association's (AEA) Orange County Council at its Eighth Annual High Tech Awards ceremony last night. The AEA recognized the Masimo Radical Signal Extraction pulse oximeter, as the Innovative Product/Technology in the medical area.
The Radical has quickly become recognized as the most advanced and versatile pulse oximeter ever conceived. In addition to providing the unsurpassed accuracy and reliability of Masimo SET pulse oximetry, Radical possesses several other features that set it apart. Its removable, battery operated module allows it to be quickly converted from a standalone bedside monitor to a handheld device, which can be used for transport or spot checks. Masimo's SatShare interface cable may also be used with the Radical pulse oximeter to upgrade existing monitors to Masimo SET performance. Many hospitals have found the SatShare interface to be most economical means of upgrading their existing monitors.
The versatility and multi-functionality of the Radical pulse oximeter make it the best solution for a hospital looking to replace all of its pulse oximetry technology with the newly recognized motion and low perfusion tolerance standards set by Masimo. A facility can replace its standalone and handheld devices with Radical pulse oximeters, and upgrade its integrated monitoring systems with SatShare. Then, all patients in the facility benefit from the improved performance of Masimo SET and clinicians do not need to decide which patients get the new technology and which can risk the old. And, with sensor standardization achieved, the hospital can keep a long lasting Masimo single patient adhesive sensor on the patient throughout their stay. Many hospitals, including Massachusetts General, are standardizing their entire facility on Masimo SET.
"We are honored that the AEA has recognized Masimo with this award," said Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. "Radical is the result of input from clinicians around the world who were looking for a pulse oximetry solution that met all of their needs. Our talented and dedicated team went beyond the call of duty in designing and building a product that meets these needs. I'm proud to say, based on the clinical and market response to Radical so far, that we achieved our goal and have delivered a product to the market that can allow clinicians to improve the level of care while saving money in the process. We thank the AEA, and I thank my team for their valiant effort."
HealthTrust Purchasing Group Signs Agreement with Masimo Corporation for Masimo Signal Extraction Pulse Oximetry
Agreement provides more than 600 healthcare facilities access to Masimo SET™
Irvine, CA May 9, 2000 - Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, today announced a 2-year agreement with HealthTrust Purchasing Group (HPG), a Nashville, Tennessee based Group Purchasing Organization (GPO), and the largest proprietary GPO in the U.S., to provide Masimo SET pulse oximetry to its hospital group.
"Masimo is pleased to provide HealthTrust member hospitals access to Masimo SET technology at group purchasing discounted prices," said Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. "This agreement will allow for HealthTrust member hospitals to acquire the Masimo SET technology, which has been linked to reduction in the incidence of medical errors due to a dramatic reduction of false alarms and improved detection of true alarms. Leading researchers have reported on these clinical benefits, referring to Masimo SET as the biggest advancement in pulse oximetry. HealthTrust clinicians, aware of these benefits, have also been asking for the choice to clinically use Masimo SET pulse oximetry. We are delighted that this new agreement, in line with HealthTrust's mission, will help provide the best care possible to HealthTrust's patients."
HealthTrust Purchasing Group, L.P. is one of the nation's leading healthcare group purchasing organizations with a current membership in excess of 600 facilities and contracting volume totaling more than $4 billion. HPG is committed to providing its customers with the highest quality, cost-effective supplies and services for their patients, physicians, nurses, and other clinicians. HPG's membership includes hospitals, surgery centers, clinics, physicians, integrated delivery networks, and affiliate members.
Masimo Receives 2001 Medical Design Excellence Award for Radical™ Signal Extraction Pulse Oximeter
Irvine, California, March 20, 2001 - Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, has been selected as winner in the 2001 Medical Design Excellence Awards (MDEA) competition for Masimo’s recently released Signal Extraction Technology™ Pulse Oximeter, Radical™. The MDEA is the only awards program devoted exclusively to recognizing contributions and advancements in the design of medical products. MDEA-winning products excel in the areas of product innovation, design and engineering excellence, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.
An impartial, multi-disciplinary panel of third-party jurors reviews all products submitted. These jurors have expertise in biomedical engineering, human factors, industrial design, medicine, nursing, diagnostics, and medical packaging. Winners are selected in ten medical product categories. Radical was selected as a winner in the division of Critical Care and Emergency Products.
Radical Signal Extraction Pulse Oximeter is three pulse oximeters in one: a standalone device for bedside monitoring, a detachable handheld pulse oximeter for portable monitoring or spot check, and with its rich interface options, including SatShare™, provides an upgrade path for the conventional pulse oximetry technologies found in hospital patient monitors to Masimo SET performance.
Radical incorporates a new version of Masimo SET software, V3™, which not only delivers the breakthrough motion and low perfusion performance of Masimo SET, but debuts FastSat™, which allows pulse oximeters to accurately track rapid saturation changes with unprecedented fidelity. Radical also debuts Signal IQ™, a unique visual indication that identifies the arterial pulse and quality of the acquired signal even under conditions of motion and low perfusion. “Radical, is the most advanced pulse oximeter in the world, yet it is simple to use,” said Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation. “Clinicians from around the world contributed to the design of Radical by challenging our engineers to take the Masimo SET engine and design a pulse oximeter body around it that would make it available to all of their patients in all of the environments they were currently using conventional pulse oximetry or couldn’t due to the limitations of conventional pulse oximeters. They also wanted one intuitive user interface for all of their applications, whether they were doing spot-check hand-held pulse oximetry measurement or continuous bedside monitoring in the OR, ICU or Ward.”
Mr. Kiani continued, “Due to the requirements and feedback by our clinical advisory group, and the ingenuity and hard work of our engineers, clinicians around the world can now benefit from Masimo SET’s unprecedented sensitivity and specificity for all their patients in all of the environments they choose; all with one intuitive user interface. We thank MDEA for this recognition, as well as, the many clinician advisors, our engineering team and the industrial design team of I.N. for creating Radical.”
Massachusetts General Hospital teams up with Masimo, GE Medical Systems and Welch Allyn Protocol to bring improved monitoring to the bedside
March 13, 2001, BOSTON - Massachusetts General Hospital (MGH) has launched an initiative to install and implement enhanced sensor technology at the patient bedside. This next generation of pulse oximetry technology, which monitors patients’ vital signs and blood oxygen levels noninvasively, is expected to increase the accuracy of these crucial medical measurements, augment patient safety, and control costs. Working with the MGH in this effort is Masimo, of Irvine, Calif., the innovator of Signal Extraction Technology for reliable monitoring during patient motion and low perfusion. Welch Allyn Protocol, of Beaverton, Ore., the manufacturer of low and mid-acuity patient monitoring systems featuring Flexible Monitoring technology, and GE Medical Systems Information Technology (GEMS-IT) of Milwaukee, the manufacturer of high-acuity integrated patient monitoring and information systems.
Pulse oximetry technology involves applying a sensor to the skin to record a patient’s blood oxygen levels. A monitor continuously displays the data, and visual and audible alarms alert caregivers to unusual blood oxygen levels and abnormal heart rates. Previously, the technology has been highly effective in monitoring those patients who are motionless, asleep and who have satisfactory circulation.
The standard equipment, however, has had drawbacks for those patients who are alert and moving as well as for those who had inadequate blood flow. “In certain situations, for example, with neonates in intensive care or patients beginning to move while recovering from surgery, the monitors may alarm excessively because the effects of motions result in an inaccurate reading,” says Penny Ford-Carleton, RN, associate director of Research Affairs at the MGH. “The next-generation oximetry technology is designed to overcome these problems.”
ECRI, an independent nonprofit health services research agency, published in its October 2000 issue of Health Devices (Volume 29, Number 10), “Next-Generation Pulse Oximetry: Focusing on Masimo SET.” This issue of Health Devices served as the impetus for MGH’s evaluation and ultimate conversion. The new pulse oximetry technology, Masimo SET, is commercially available through a device developed by Masimo, called the “Radical Signal Extraction Pulse Oximeter.” It has already been successfully installed in MGH’s Cardiac Surgical Service and Neonatal Intensive Care Unit. With these two initial installations, Ellen Kinnealey, R.N, bedside technology specialist at the MGH, says that one challenge now is satisfying end-user demand for this new technology. “Other patient care areas have heard that installations are beginning, and they all want to be next in line. The ‘longfelt need’ for improved oximetry is high.”
The new technology relies on sturdy sensors, advanced low-power hardware, and adaptive digital signal processing that can more precisely distinguish arterial blood flow from noise. This enhanced equipment potentially can expand the benefits of pulse oximetry to more patients, making bedside monitoring more reliable and ultimately improving patient safety.
“Pulse oximetry has been a key technology enhancing patient safety,” says Jeffrey B. Cooper, PhD, director of Biomedical Engineering at Partners HealthCare System, of which the MGH is a founding member. “Abnormal blood oxygen levels are often an early warning signal of a problem. The wide introduction of pulse oximetry is believed to have contributed to a striking increase in patient safety. Our hope is that patient safety will increase further as the Masimo SET pulse oximetry technology replaces conventional pulse oximetry technology.”
Kinnealey adds: “The goal in implementing the new pulse oximetry technology is to achieve affordable, extensive deployment of the equipment. The hospital is replacing its current stand-alone monitors in operating rooms with the new equipment. In other areas the new technology will be used as an accessory to the hospital’s existing monitors, most of which have been manufactured by GE Medical and Welch Allyn Protocol.
“Working together with these companies, we have inventoried our installed monitors and have developed an upgrade program,” Kinnealey says, adding that the goal is to make whole-hospital transition to next-generation oximetry as simple and seamless as possible.
“Using the enhanced oximetry technology as a universal accessory across all existing monitoring platforms allows the MGH to complete the widespread implementation of the new pulse oximetry equipment quickly and cost effectively”, says Nat Sims, MD, physician adviser, MGH Biomedical Engineering. “We have looked at our historical costs associated with oximetry, and we are confident that we can adopt next-generation oximetry technology in a cost-neutral fashion,” Sims says. “We believe there will be a reduction in net sensor use - one sensor will stay with a patient throughout the time that patient needs oximetry. In addition, we will achieve significant offsets by reducing some unnecessary blood gas testing. Finally, intangible benefits related to risk management and patient and caregiver satisfaction must be considered.”
The Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The 855-bed academic medical center conducts the largest hospital-based research program in the United States, with an annual research budget of more than $250 million and major research centers in AIDS, the neurosciences, cardiovascular research, cancer, cutaneous biology, transplantation biology and photomedicine. In 1994, the MGH joined with Brigham and Women’s Hospital to form Partners HealthCare System, an integrated health care delivery system comprising the two academic medical centers, specialty and community hospitals, a network of physician groups and nonacute and home health services.
GE Medical Systems Information Technologies Forms Alliance with Masimo Corporation for Patient Monitoring Pulse Oximetry Technology
GE First to Introduce High-Acuity Patient Monitoring Systems with Masimo SET
MILWAUKEE, Wis., (February 26, 2001) - GE Medical Systems Information Technologies today announced an alliance with Masimo Corporation, the innovators of an enhanced noninvasive pulse oximetry technology that indicates if vital organs and tissues are receiving an adequate supply of oxygen, called Signal Extraction Technology (SET). This alliance allows GE to incorporate Masimo SET Pulse Oximetry into all major GE patient monitoring systems, which can help clinicians treat patients by significantly reducing false alarms, and more accurately tracking pulse oximetry in patients with poor perfusion or weak pulses.
“The agreement with Masimo is an important strategic addition for GE. After evaluating the various pulse oximetry technologies available, we decided to strengthen our relationship with Masimo because we believe they have created a distinct technology that will strongly benefit health care providers and their patients,” said Greg Lucier, president and CEO of GE Medical Systems Information Technologies.
In conjunction with the companies’ expanded alliance, GE is introducing the industry’s first high-acuity patient monitoring system that utilizes Masimo’s advanced SET Pulse Oximetry, called the GE Solar® SpO2 Module with Masimo SET®. GE will also offer the Masimo SET technology as an option to its existing and future Solar monitoring systems. In addition, GE plans to incorporate Masimo SET Pulse Oximetry into its full line of patient monitoring systems including TRAM, DASH® and DINAMAP® Pro.
“By incorporating a complete collection of best-in-class parameters in our patient monitoring systems, including Masimo SET Pulse Oximetry, GE provides clinicians with a ‘one-stop-shop’ for the reliable, real-time vital signs information,” said Kevin King, vice president of Clinical Systems for GE. “Our strategy to integrate the most advanced technologies into our patient monitoring systems creates a new level of monitoring performance that is clinically essential and fully supportive of our customers’ efforts to create a comprehensive electronic patient medical record.”
Before the advent of Masimo SET Pulse Oximetry, nine-out-of-ten pulse oximeter alarms were false alarms, causing clinician indifference to pulse oximeter alarms. In the past six years, more than 40 published clinical studies have demonstrated that Masimo SET virtually eliminates false alarms while improving the detection of true alarms. Some of these studies suggest that Masimo SET has helped to save lives and improve patient care, while reducing the cost of care as a result of its unprecedented accuracy and reliability. The latest study, which earned the Best ASA Abstract Award by the Society for Technology in Anesthesia for Dr. Charles Durbin at University of Virginia, suggests that Masimo SET could help reduce human errors linked to unnecessary mortality and morbidity.
“Clinicians in acute care settings have trusted GE to give them the best vital signs monitoring systems and arrhythmia analysis technology for more than 30 years. We are proud to have been selected as GE’s standard Pulse Oximetry offering and committed to the complete integration of our technology into GE’s patient monitoring systems,” said Joe E. Kiani, president and CEO of Masimo Corporation. “GE’s vast distribution channels will make our technology available to clinicians at health care institutions around the world - and to the patients they treat.”
Pulse oximetry is a noninvasive monitoring method that shows how well a patient’s cardiovascular and respiratory system is functioning, and indicates whether vital organs and tissues are receiving an adequate supply of oxygen. Changes in the oxygen level provide one of the earliest, most crucial signs of possible patient distress - up to four minutes in advance of critical problems, compared to as little as ten seconds for an electrocardiograph monitor.
About GE Medical Systems Information Technologies GE Medical Systems Information Technologies is a global leader in providing solutions for the reliable and efficient acquisition, analysis and management of patient data in health care facilities around the world. The company’s offerings include cardiology, patient monitoring, image management, clinical information systems and performance management services. Information Technologies is a GE Medical Systems Company with global headquarters in Milwaukee, Wis. GE Medical Systems is a $7 billion global leader in medical technology and services. Additional information about GE Medical Systems and Information Technologies can be found on the company’s Web site at www.gemedicalsystems.com.
Masimo Introduces MS-5™, Low Power Signal Extraction Pulse Oximetry™ OEM Board
Irvine, California, January 18, 2001 - Masimo Corporation, the innovator of Signal Extraction Pulse Oximetry, announced today that it has completed development and testing of a new low power and low profile pulse oximetry printed circuit board. This product, named the MS-5, is now in full production. The MS-5 utilizes approximately 0.5 Watt, roughly one-half the power of the MS-3™board and a quarter of the power of Masimo’s first OEM printed circuit board, the MS-1™.
The MS-1, MS-3 and MS-5 boards carry the Masimo SET signal processing algorithm and are sold to Masimo’s licensees for incorporation to their patient monitors and therapeutic devices. Once integrated, these instruments then give Masimo SET performance when any of the full line of Masimo single patient adhesive or reusable sensors are connected to them. To date, Masimo has licensed its Signal Extraction pulse oximetry technology to over 35 patient monitoring companies, representing over 60% of the pulse oximetry market.
Measuring at about the size of a business card, the MS-5 is designed to be utilized within instruments where size and power are at a premium but still need to have the revolutionary motion and low perfusion performance of Masimo SET.
MS-5 also incorporates a new version of Masimo SET software, which not only delivers the motion and low perfusion performance of Masimo SET, but debuts FastSat®, which allows pulse oximeters to accurately track rapid saturation changes with unprecedented fidelity, while rejecting false alarms due to motion artifact and low perfusion. This software release also debuts Signal IQ™, a unique visual indication, which visually identifies the arterial pulse even under motion and low perfusion, with its height displaying the quality of the acquired signal. These new features will also be available to Masimo’s licensed partners.
One of the first products to integrate the Masimo SET MS-5 low power, low profile OEM board is the Micropaq™, from Welch Allyn Protocol Inc.® The Micropaq, a wireless ambulatory patient monitor designed to meet the increasing demands for ambulatory patient monitoring of cardiac patients, recently received market clearance from the FDA. "In ambulatory monitoring, reliability during patient motion is a must," stated Robert F. Adrion, President and Chief Executive Officer of Welch Allyn Protocol Inc. "The proven performance of Masimo SET, together with the low power of the MS-5, is one of the key features that makes Micropaq a valuable patient monitor to clinicians."
Joe E. Kiani, President and Chief Executive Officer of Masimo Corporation, stated, “I am extremely proud of our engineering team, they are the brightest and most dedicated team that I have ever had the pleasure to work with. They keep raising the bar for betterment of patient care. The MS-5 is the first commercially available pulse oximetry technology that enables accurate monitoring during motion and low perfusion in ambulatory, telemetry and other environments where size and power consumption are limiting factors.”
Masimo Corporation Presents at JP Morgan H&Q Healthcare Conference; Masimo Doubles OEM Business in 2000
SAN FRANCISCO, Jan. 10 -- Masimo Corporation this week presented at the 19th Annual JP Morgan H&Q Healthcare Conference. Masimo, a privately-held medical technology company, is the innovator of breakthrough signal processing and sensor technology for patient monitoring and the market leader of motion and low perfusion tolerant pulse oximetry. Joe E. Kiani, President and CEO, reported that the Company continued to make significant progress in 2000 on all fronts.
Clinical Validation Mr. Kiani told the audience that a dozen more independent clinical studies had been published in 2000, adding to 5 years of clinical research resulting in more than 35 publications on Masimo SET. All of these studies have shown that Masimo SET has overcome the limitations of conventional pulse oximetry, in terms of the high rate (up to 90%) of false alarms and the inability to detect true alarms during challenging conditions.
Market Adoption Mr. Kiani reported that the Company had signed worldwide licensing agreements with several significant companies, including GE Medical Systems, Hill-Rom and Welch-Allyn Protocol, bringing the total to over 35 companies. These partner companies represent over 60% of all pulse oximeters shipped worldwide.
2000 Results Mr. Kiani stated that the Company's revenues more than doubled in 2000. In the second full year of shipments, since the first Masimo SET product was launched in the U.S. by Datascope, Masimo shipped over 23,000 OEM modules, compared to approximately 12,000 in 1999. These shipments have resulted in a worldwide Masimo SET installed base of approximately 40,000 units. ``We are delighted to see the clinicians' fast rate of adoption of Masimo SET pulse oximetry and our OEM partners' strong sales activities,'' commented Mr. Kiani.
New Products Mr. Kiani also announced the new Radical Signal Extraction Pulse oximeter. Radical is a three in one pulse oximeter, which can be used as a handheld device, a standalone bedside monitor and, via its proprietary SatShare interface, Radical can upgrade validated multiparameter patient monitors with antiquated, conventional technology to Masimo SET performance. Mr. Kiani, also briefly discussed some of the Company's Research and Development activities, including continuous, noninvasive blood pressure (CNIBP) monitoring which is considered one of the most significant advancements still to be achieved in patient monitoring.
Recent Financings Masimo has raised approximately $75 million in private equity financing from some of the most respected names in healthcare investing. Most recently Franklin Templeton and GE Medical Systems invested $15 million in Masimo Corporation.