IRVINE, Calif., May 30, 2013 /PRNewswire/ -- Masimo (NASDAQ: MASI), the inventor of measure-through motion and low perfusion pulse oximetry today renewed its $1,000,000 (USD) guarantee that Masimo SET ® Pulse Oximetry and rainbow ® Pulse CO-Oximetry™ will outperform all Nellcor™ pulse oximeters, including the three that Covidien recently announced have received FDA 510(k) clearance with motion claims. 1,2 This offer is available only to hospitals whose goal is to upgrade their pulse oximetry hospital-wide to the new standard. Important details, conditions, and qualifications for the guarantee are available at http://www.masimo.com/1millionrules.htm. 3
"Masimo has always stood for the truth," stated Joe Kiani, Founder and CEO of Masimo. "Covidien's recent announcements appear to be an attempt to create an impression that Nellcor products are clinically equivalent, or even superior, to Masimo's products. In fact, the performance of Nellcor pulse oximeters has not changed since 2006 when they introduced the version of their technology that is still the same today, after the U.S. Court of Appeals for the Federal Circuit directed the Federal District Court in Los Angeles to enjoin the Nellcor pulse oximeter that infringed Masimo's breakthrough measure-through motion patents. All studies we are aware of show that the current Nellcor technology does not match the performance of Masimo SET ® technology during challenging motion conditions. We hope this $1,000,000 guarantee sends a clear message to clinicians, biomedical engineers, materials management, and hospital administrators to look to the objective evidence when they are interested in improving pulse oximetry performance."
Dr. Michael O'Reilly, Chief Medical Officer for Masimo, stated: "The ability of Masimo SET ® to detect oxygen saturation changes (sensitivity) and avoid false alarms (specificity) is proven by more than 100 independent and objective studies, internal studies, and thousands of clinical evaluations. Most importantly, only Masimo SET ® pulse oximetry has been shown to improve patient outcomes by helping clinicians reduce retinopathy of prematurity, 4 screen newborns for critical congenital heart disease (CCHD), 5,6 reduce ventilator weaning time, 7 and save lives while reducing rapid response activations and intensive care unit transfers on the general floor." 8Dr. O'Reilly continued: "Since we introduced Masimo SET ®, we have converted more than 2,600 hospitals worldwide. Yet, in the same period, fewer than one in 100 hospitals have switched from Masimo, and to the best of our knowledge, none did so due to performance. We understand that hospital conversions to a new technology require time and effort. We are so confident in the performance of Masimo technology and the difference it will make in the care of patients that we are willing to assure care providers that their time and efforts will not be wasted with our $1,000,000 guarantee." Dr. Peter Cox, Clinical Director, Critical Care Medicine & Associate Chief Physician, Department of Critical Care Medicine at the Hospital for Sick Children in Toronto, stated: "Recently published reports support the notion that Masimo SET ® pulse oximetry outperforms Nellcor pulse oximetry during motion and low perfusion conditions. Measure-through motion and low perfusion performance can be validated by changing the true arterial oxygen saturation during motion and low perfusion conditions. In the recently published study of SpO 2 accuracy in both machine- and volunteer-generated motion, Masimo SET ® had 97% sensitivity and 95% specificity while the Nellcor N-600 had 57% sensitivity and 72% specificity." 9 Dr. Anne Granelli—lead author on one of the largest published CCHD studies to date, liaison to the U.S. Department of Health and Human Services Secretary's Advisory Committee on Heritable Diseases in Newborns and Children (SACHDNC) workgroup, and author of an award-winning doctoral thesis in this field—stated: "While working at one of the two centers in Sweden that performed pediatric cardiac surgery, I found a significant difference, when compared simultaneously with blood gas, between Masimo SET ® and all other pulse oximetry technologies we used on cyanotic children in the PICU and pediatric cardiac ward. We were not aware of the significant difference between oximeters before this clinical study. And, as a result, we upgraded all our pulse oximeters to Masimo SET ®." Dr. Kenneth Rothfield, Chairman of Anesthesiology at Saint Agnes Hospital in Baltimore, stated: "In my 20 years' experience, I have used other pulse oximeters that claimed to tolerate motion, but this is easier said than done. When a patient's life hangs in the balance, a pulse oximeter that cannot measure despite motion and low perfusion is useless—and that can have dangerous consequences. That's one of the many reasons my hospital switched from Nellcor to Masimo SET ®. Masimo SET ® doesn't just tolerate motion, it measures through it – accurately and consistently." Background On May 20, 2013, Covidien announced FDA 510(k) clearance with motion claims for three Nellcor ™ pulse oximeters and stated they are the " first company to receive FDA 510(k) clearance for a motion-tolerant bedside pulse oximeter portfolio that is compliant with ISO 80601-2-61," a new pulse oximetry testing standard. 1 On May 28, 2013, Covidien announced that " Nellcor Pulse Oximeters Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart Disease." 2 Covidien's announcements may cause confusion because: