Masimo this week announced that its O3 Regional Oximetry received expanded FDA clearance.
The expanded use covers monitoring somatic tissue oxygenation saturation in all patient populations and monitoring relative changes in hemoglobin, oxyhemoglobin and deoxyhemoglobin in adult brains. O3 is also now indicated for use in both cerebral and somatic applications.
The oximetry device uses O3 multi-wavelength sensors and O3 Regional Oximetry near-infrared spectroscopy technology to provide regional or tissue hemoglobin oxygen saturation.
“There is a growing interest in the use of somatic NIRS owing to the association of cerebral and somatic desaturation with unfavorable outcomes in shock states. As an addition to O3 cerebral oximetry, the somatic component could serve as an earlier warning of impaired tissue perfusion. Somatic NIRS has been validated as a monitor of peripheral perfusion and shows an excellent correlation with peripheral perfusion compared with radionuclide plethysmography. As previously reported,3 cerebral and somatic NIRS combined with bedside whole-body ultrasound can help in early detection of different types of shock to formulate proper therapeutic strategies,” Dr. André Denault of the Montreal Hearth Institute and Central Hospital of the University of Montreal said in a news release.
O3 measurements ΔcHb, ΔO2Hb and ΔHHb have also been cleared by the FDA for monitoring relative changes in oxygenated hemoglobin, deoxygenated hemoglobin and total hemoglobin in adult brains. The expanded indication gives clinicians more information regarding the dynamic relationship with oxygen and hemoglobin in the brain that brain oxygenation saturation alone might not provide.
“When using regional oximetry to monitor the brain, rSO2 helps track the oxygenation state of the brain, but understanding the dynamic variations in rSO2 is even more valuable. Changes in rSO2 may be a function of a change in hemoglobin or perfusion, or may result from an oxygen desaturation event. In my practice, I use Masimo O3 ΔcHb, ΔO2Hb, and ΔHHb to gain insight into the relative changes in hemoglobin and perfusion in the brain to help enable earlier detection and intervention during adverse changes to cerebral blood flow,” Dr. Aamer Ahmed, a consultant cardiovascular anesthesiologist at University Hospitals of Leicester U.K., said.
“O3’s expanded indication as a monitor of the oxygenation and deoxygenation components of cerebral tissue, along with the oxygen saturation of somatic tissue, represents an important milestone in helping clinicians and researchers shed additional light on how the body utilizes oxygen and in uncovering organ hypoxemia,” Masimo founder and CEO Joe Kiani said.