The U.S. Food and Drug Administration (FDA) is now allowing the marketing of ClearMate, a new device that is designed to be used in an emergency room setting, to save a patient with severe carbon monoxide poisoning.
According to the FDA, approximately 500 carbon monoxide deaths occur in the United States every year from unintended exposure, and about 20,000 individuals will visit the emergency room to seek medical assistance.
Currently, the standard treatment of carbon monoxide poisoning is to administer 100% oxygen to the patient, through a mask. In severe cases, hyperbaric treatment is necessary, that goes beyond the standard mask. There are only 60 medical centers in the United States with hyperbaric units, which makes access a problem, especially for those in rural areas.
The new FDA-approved device, ClearMate, works to quickly remove carbon monoxide from the body by increasing the patient’s rate of breathing. It delivers 100% oxygen, as well as a mixture of oxygen and carbon dioxide, which increases the breathing rate. The increased breathing rate accelerates the pace at which the carbon monoxide exits the body.
The FDA examined the clinical studies of 100 patients and found that ClearMate was effective at eliminating carbon monoxide, and it did so at a faster rate than using only 100% oxygen. The studies also noted that patients did not have any issues regarding the safety or efficacy of ClearMate.
The device was reviewed under the FDA’s De Novo premarket review pathway, and the FDA granted marketing authorization of ClearMate to Thornhill Research, Inc.
The FDA works to protect the health of the public by ensuring the efficacy, safety, and security of medical devices, such as ClearMate. Orbis Biosciences believes in the dedication to not only improve how people feel better, but is committed to making improvements in the health sector.