Masimo Corp has received a CE Marking for its O3 regional oximetry technology, according to a company announcement. Regional oximetry (also known as tissue oximetry and cerebral oximetry) allows the continuous assessment of tissue oxygenation beneath a sensor placed on the patient’s skin. The approval will allow Masimo to market the product within the European Union.
Masimo’s O3 sensors use near-infrared spectroscopy (NIRS) to continuously and simultaneously measure regional oxygen saturation (rSO2) and arterial oxygen saturation (SpO2). The technology can help clinicians detect regional hypoxemia that pulse oximetry alone can miss, according to Masimo.
Sensors are equipped within Masimo Open Connect (MOC-9) modules. The modules are applied to the patient’s forehead and connected to the company’s Root patient monitoring and connectivity platform. Root allows either one or two O3 MOC-9 modules to be connected, enabling monitoring with as few as one and as many as four sensors.
When evaluated with arterial and venous blood gas samples, O3 regional oximetry had an absolute accuracy of 4.0% and trend accuracy of 2.1%, based on results from an abstract presented at the Society for Technology in Anesthesia 2014 Annual Meeting in Orlando, Fla. The study evaluated cerebral oxygen saturation on 23 subjects and 202 paired measurements of rSO2 from O3 regional oximetry and reference arterial and venous blood samples (SavO2). Reference blood samples were taken from both an arterial cannula placed in the radial artery and a catheter placed in the internal jugular bulb vein, obtained at baseline and after a series of increasingly hypoxic states.
Simultaneous measurement of rSO2 and SpO2 “may provide the anesthesiologist or perfusionist for the first time with a differential analysis of regional to central oxygen saturation monitoring that could help the clinician in maintaining brain oxygenation and safe cerebral perfusion during cardiac procedures,” said Michael Ramsay, MD, chief of the Department of Anesthesiology and Pain Management at Baylor University Medical Center, Dallas.
O3 regional oximetry is currently intended for use in subjects larger than 40 kg (88 lbs) and has not yet received FDA 510(k) clearance, Masimo noted.