Thornhill Medical’s device to help patients suffering from carbon monoxide poisoning has won de novo clearance from the FDA.
Carbon monoxide poisoning occurs when carbon monoxide attaches to the hemoglobin in the blood exactly where oxygen is supposed to attach, reducing the amount of oxygen carried to the brain and other tissues. Toronto-based Thornhill Medical’s ClearMate device uses a novel method for quickly removing carbon monoxide from the body by increasing a patient’s breathing rate, according to the FDA. The increased breathing accelerates the rate at which the carbon monoxide leaves the patient, allowing a normal amount of oxygen to attach to hemoglobin for delivery throughout the body.
ClearMate consists of a gas mixer, valves, meters, breathing circuits, an oxygen reservoir, a mask and hoses, and delivers 100% oxygen and a mixture of oxygen and carbon dioxide, causing the patient to breathe faster. It is intended for emergency room use.
Standard treatment for carbon monoxide poisoning is to have the patient breathe 100% oxygen through a mask. A hyperbaric chamber, which delivers oxygen under higher-than-normal pressure, may be used in severe cases, but few U.S. medical centers have hyperbaric chambers, according to the FDA. Studies reviewed by the agency showed that ClearMate’s combination of oxygen and carbon dioxide eliminated carbon monoxide faster than treatment with 100% oxygen alone but was not faster than hyperbaric oxygen therapy.
“Carbon monoxide poisoning is a serious issue, affecting thousands of people each year,” said Dr. Malvina Eydelman, director of FDA’s division of ophthalmic, and ear, nose and throat devices, in a prepared statement. “While the current standard treatment of administering 100 percent oxygen through a mask can be done anywhere, hyperbaric treatment, which is necessary for severe carbon monoxide poisoning, is less accessible because there are only 60 medical centers with hyperbaric units in the entire U.S. Moreover, those medical facilities are seldom in rural areas, so treatment in those areas could be delayed considerably due to transport time. Today’s marketing authorization provides patients with access to a simple, yet lifesaving device that may minimize the delay of getting vital treatment, especially in severe cases of carbon monoxide poisoning.”
Carbon monoxide is a colorless, odorless gas that is extremely poisonous and can kill within minutes. In the U.S. each year, nearly 500 people die while as many as 20,000 visit emergency rooms for unintended exposure to carbon monoxide, primarily from poorly-maintained heating systems, or gas stoves or gas-powered generators used for heat or power during storms. The most common symptoms of carbon monoxide poisoning are headache, dizziness, weakness, upset stomach, vomiting, chest pain and confusion.