Masimo is committed to delivering truthful information. Unfortunately, Nellcor repeatedly makes false statements that can deceive some healthcare professionals. While Masimo will continue to focus on innovating, the increasing frequency of these false and misleading tactics—coupled with a Nellcor executive’s public statements that Nellcor finds these practices effective—compels us to address some of these “Nellcor Fictions” head-on in support of our mission to improve patient care and reduce the cost of care by taking noninvasive monitoring to new sites and applications.

Nellcor performs just as well as Masimo during patient motion and low perfusion.

• Eighty-six independent and objective studies conclude that Masimo significantly outperforms Nellcor during patient motion and low perfusion.
• To the best of Masimo’s knowledge, not a single published study concludes that currently available Nellcor technology (N-600/N-600x) performs as well or better than Masimo technology during conditions of motion and low perfusion.
• Masimo’s superiority is easy to see in side-by-side demonstrations. Masimo encourages real-world, head-to-head clinical evaluations of its technology against any other pulse oximetry technology. In Masimo’s experience, Nellcor avoids head-to-head comparisons, especially ones that are objectively documented with automated data collection systems.
• Masimo offers hospitals a Performance Superiority Guarantee that Masimo pulse oximeters will outperform Nellcor oximeters on challenging patients. Masimo recently raised this guarantee to
  $1 Million.

Masimo SET continues to read on patients even when there is no pulse.

• Masimo SET’s ability to accurately measure through motion and low perfusion does not change the basic principle of pulse oximetry, which requires pulsating blood by definition.
• Masimo performs better under conditions of very low perfusion than other pulse oximetry technologies—including Nellcor’s.

Nellcor video shows Masimo continues to read on a subject while a dual-bladder tourniquet is inflated to 250 mmHg. Nellcor asserts this establishes that Masimo continues to read when there is no pulse.

• The “experiment” Nellcor designed is a flawed simulation of a pulseless state, which shows a single instance where Masimo continues to read through cuff inflation when Nellcor did not.
• During a true pulseless state, it is not possible for Masimo products to provide measurements because Masimo’s algorithm requires a pulsatile signal.
• Masimo’s internal studies prove that while cuff inflation will occlude blood flow to the sensor site on more than 80% of subjects, both Nellcor and Masimo pulse oximeters will inconsistently provide measurements on some subjects during cuff inflation due to physiological variations.
• In fact, if Masimo wanted to show a video displaying Nellcor measuring through cuff inflation while Masimo did not, it could easily be done – but that would be misleading, as well.
• After Nellcor first released this video, Masimo CEO Joe Kiani contacted Rich Meelia, the CEO of Nellcor’s parent company, Covidien, notifying Mr. Meelia that Nellcor’s video was deceptive and asking him to stop distributing it. Mr. Meelia refused, indicating that he needed to trust his management team. Mr. Kiani requested to meet with Mr. Meelia—and any clinicians, engineers, or legal staff he wished to bring—so they could jointly perform the experiment and determine whether the video was truthful. Mr. Meelia refused such a meeting.

A study by Massachusetts General Hospital (MGH) published in Anesthesiology regarding Masimo’s pulse tone (SmarTone) is further proof that Masimo reads when there is no pulse.

• There was no study, but rather a letter to the editor.
• Masimo’s pulse tone algorithms (including SmarTone), are completely independent of its pulse rate and saturation algorithms.
• SmarTone uses Masimo’s advanced signal processing technology to maintain saturation tones with variable pitch—even during low signal-to-noise conditions such as motion artifact—when gaps in the tone not relating to true physiological events could cause an undue distraction during clinical procedures, or cause latent response to changing physiology. An eight second buffer in the SmarTone algorithm means the pulse tone may continue for up to eight seconds after the pulse stops and the pulse rate and SpO₂ readings on the Masimo device zero out.
• When questioned by a Mass General official as to why he didn't test the device with Masimo's "Normal Tone," which Masimo had provided to him, the biomedical engineer who was the first author on the letter responded that the clinical situation is so rare that he would be unlikely to observe it. Another author of the letter stated that a study to evaluate the behavior was impractical.
• Massachusetts General Hospital continues to use Masimo pulse oximetry technology throughout the hospital, as does Brigham and Women’s and other hospitals in the Partners HealthCare Network.

Masimo’s Patent Infringement Claims were without merit.

• Nellcor lost a patent infringement lawsuit and paid $265 million to Masimo after it was determined Nellcor had infringed Masimo’s technology in their N-395, N-550, and N-595 products.
• The Federal Court of Appeals in Washington DC upheld this finding.
• A top Nellcor engineer was in possession of a confidential Masimo design document.
• Top Nellcor engineers were instructed to write computer code to “resemble” Masimo patents.
• Although Nellcor brought a patent suit against Masimo accusing Masimo of infringing 10 Nellcor patents, Masimo was not found to infringe any of Nellcor’s patents.

The Nellcor N-600 and N-600x perform as well as or better than their earlier generation products found to infringe on Masimo patents.

• After losing the patent lawsuit Nellcor faced an imminent injunction on the N-395 and N-595.
• With the discontinuance of the products found to infringe, Nellcor announced a new product, known as the N-600, which was not subject to the litigation. Nellcor did not include adaptive filters or parallel algorithms to measure saturation in this product, which remain significant contributors to the unparalleled performance of Masimo SET and Masimo Rainbow SET oximeters.
• Although Masimo believed the N-600 design still infringed some of Masimo’s patents, after testing the N-600 oximeter provided to Masimo by Nellcor, Masimo agreed to provide a covenant not to sue Nellcor on the N-600 platform in exchange for an on-going royalty. However, if Nellcor improves the performance of the N-600, the improved product may not be covered by the covenant not to sue.
• Nellcor changed its FDA indications and directions for use for the
  N-600 and N-600x
  • FDA indications and directions for the N-595 stated the device was intended for use “during both motion and no motion conditions.” For the new N-600 and N-600x devices, the intended use statement does not include these indications for use.
  • While the N-395 and N-595 manuals make no mention of it, Nellcor’s N-600x manual states the N-600x utilizes up to 50 seconds of “averaging” for pulse rate and 40 seconds of "averaging" for SpO2 during motion
  • Nellcor recently introduced the N-600x, but Nellcor’s own website says: “The OxiMax N-600x pulse oximeter has the same signal processing technology as the OxiMax N-600 pulse oximeter.”
• Independent studies show Nellcor products produced after the settlement perform worse than their previous products.
• The superiority of Masimo SET vs. the Nellcor N-600/N-600x is observable in a side-by-side demonstration and clinical evaluations.

Masimo technology is a trick.

• While publicly saying Masimo technology was a trick, Nellcor was internally acknowledging Masimo accomplishments, stating that Masimo has made "the biggest strides in technology advancement."
• Masimo received the first-ever FDA 510(k) clearance for:
• SpO2 and pulse rate accuracy during motion
• SpO2 and pulse rate accuracy during low perfusion
• SpO2 and pulse rate accuracy on cyanotic infants
• Noninvasive and continuous carboxyhemoglobin (SpCO^®)
• Noninvasive and continuous methemoglobin (SpMet^®)
• Noninvasive and continuous pleth variability index (PVI™)
• Noninvasive and continuous total hemoglobin (SpHb™)
• Noninvasive and continuous oxygen content (SpOC™)

Nellcor invented pulse oximetry.

• Nihon Kohden invented pulse oximetry in 1972.
• The first commercialized pulse oximeter in the US was launched by Biox in 1981.
• Nellcor was founded in 1981 and did not introduce a pulse oximeter until 1983—eleven years after the invention of pulse oximetry and two years after the first commercialization of the technology.

Nellcor uses a cardiac-based algorithm, while Masimo uses a saturation-based algorithm to determine oxygen saturation and pulse rate.

• There is no such thing as a cardiac-based pulse oximetry algorithm, since pulse oximetry, by definition, analyzes pulses via plethysmographic waveforms (pleth) derived from peripheral vascular measurements. Nellcor’s own description of their “cardiac cycle” based method states clearly that they are using pulse waveforms to make their calculations.
• Masimo's patented parallel engines use multiple algorithms—including both pulse- and saturation-based algorithms— to provide the world’s most accurate SpO2 and pulse rate. In contrast, Nellcor only uses pulse based algorithms.

Masimo is unique in providing readings in certain situations when the probe is off the patient.

• All sensors that can open sufficiently so that the photo emitter and detector do not oppose each other (e.g. Masimo LNCS Adt, Nellcor Oximax A) may continue to provide measurements during some probe-off conditions.
• Masimo in Adaptive Probe Off Detection mode (APOD™) has the best probe-off detection capability of any pulse oximeter.

The Nellcor N-600x is accurate on cyanotic infants from 60% to 100% at plus or minus 3%.

• The documents Nellcor makes available showing clinical validation for its low saturation claims involve tests on healthy adult subjects, not cyanotic patients (infant or older).
• In fact, independent studies on cyanotic infants show that only Masimo with the Blue sensor is accurate and meets its claimed accuracy specification in this population.
• Independent studies show Nellcor’s real-world performance in low saturation conditions does not match its published specifications on cyanotic patients.
• Masimo is the only company with FDA cleared claims for accuracy on cyanotic infants.

Nellcor’s new forehead sensor is groundbreaking.

• Forehead sensors have been around since the late 1980s, but are not in widespread clinical use due to their unreliability with patients who are supine or in trendelenberg position. In these positions, venous pulsation can make the measurements inaccurate.
• Masimo also has a forehead sensor, and independent studies have shown it to be superior to Nellcor’s MaxFast forehead sensor. However, Masimo does not actively promote its use due to the limitation of the forehead as a measurement site.

Nellcor’s alarm management techniques are effective in reducing nuisance alarms in all patients without delaying clinical intervention.
 

• The Nellcor N-600x uses a combination of extended averaging times (up to 50 seconds of “averaging” for pulse rate and 40 seconds of "averaging" for SpO2 during motion) and clinician-selectable alarm suppression (SatSeconds) to manage nuisance alarms.
• With the introduction of SatSeconds on the N-395 (which worked better than the N-600x during motion to reject false alarms), Nellcor claimed an 89% reduction in “false alarms.” By contrast, Masimo achieves more than a 93% reduction in false alarms without SatSeconds or extended averaging.
• SatSeconds prevents Nellcor devices from audibly alarming for up to 100 seconds after an alarm threshold is breached. While this can reduce the nuisance of false alarms, it also means that clinicians may not be notified of real, actionable events.
  
• While Nellcor markets SatSeconds for use on all patients, including neonates, in a letter to the US Senate rebutting a neonatologist’s testimony at a Senate Hearing, Nellcor said that SatSeconds is not intended for neonates.
• In the early 1990s, Nellcor openly criticized a competitive product (Criticare Systems) that froze values for up 40 seconds, and claimed it was responsible for a patient’s death. However, in 1994 Nellcor introduced OxiSmart, which froze and delayed alarms for up to 60 seconds (in fact one study showed it could freeze even longer).

The tactics of Nellcor are just fair competition in the marketplace.

• In a Federal antitrust lawsuit against Nellcor (pending appeal), the jury and judge found that Nellcor engaged in anti-competitive practices, violating the Sherman Anti-Trust Acts and the Clayton Act.