Masimo announced that ORi, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA. Enabled by the multi-wavelength Masimo rainbow® Pulse CO-Oximetry platform, ORi is designed for use in conjunction with oxygen saturation (SpO2) to provide increased resolution of changes in oxygenation under supplemental oxygen. With the De Novo, ORi becomes the first-of-its-kind parameter cleared by the FDA to help clinicians manage oxygen of adults undergoing surgery in perioperative hospital environments.
Without ORi, there is no noninvasive way to monitor oxygenation under supplemental oxygen to manage hyperoxia, or higher than normal oxygenation of arterial blood. There is growing evidence that hyperoxia is harmful and can lead to oxygen toxicity, causing oxygen poisoning or pulmonary tissue damage.1 Currently, clinicians take blood draws that are analyzed to determine PaO2 levels, the partial pressure of oxygen measured by arterial blood gas devices. However, arterial blood analyses are both intermittent and delayed – leaving clinicians blind to the changes in oxygenation occurring between blood draw results.
Masimo ORi addresses these shortcomings by providing continuous insight into the oxygenation of hemoglobin in the moderate hyperoxic range (PaO2 > 100 and ≤ 250 mmHg). ORi is trended continuously with SpO2 as a unit-less index between 0.00 and 1.00 to extend the visibility of the oxygenation of patients beyond SpO2 under supplemental oxygen. By convention, SpO2 is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered. ORi provides clinicians with additional visibility, as a complement to Masimo SET pulse oximetry, into when oxygenation is increased into, or decreased out of, moderate hyperoxia, in real time.
Joe Kiani, Founder and CEO of Masimo, said, “Since ORi’s availability and success outside the U.S., perioperative clinicians in the U.S. have been waiting for a way to noninvasively monitor patients under supplemental oxygen beyond the limits of SpO2. We are thrilled that U.S. clinicians can now integrate ORi monitoring – available now on our rainbow SET platform – into their oxygenation monitoring practices, alongside Masimo SET® Measure through Motion and Low Perfusion™ pulse oximetry, and experience their combined benefits.”
With the De Novo, Masimo is introducing a new sensor line to the market, RD rainbow™ 4λ sensors, expanding the RD family of pulse CO-oximetry sensors, which are now available in four levels of capabilities:
- RD SET®, which utilizes two wavelengths (2 LEDs) and features SET® pulse oximetry.
- RD rainbow 4λ, which utilizes four wavelengths (4 LEDs) and adds the ability to measure ORi.
- RD rainbow 8λ, which utilizes eight wavelengths (8 LEDs) and enables SpHb® (total hemoglobin) monitoring alongside ORi and other measurements.
- RD rainbow 12λ*, which utilizes twelve wavelengths (12 LEDs) and offers 12 total parameters, including SpHb, ORi and fractional oxygen saturation (SpfO2™) for visibility of the impact of dyshemoglobins, SpCO® and SpMet®, on the patient’s oxygenation.
SOURCE: Businesswire