FDA grants marketing authorization to carbon monoxide poisoning treatment
The FDA recently granted marketing authorization to Thornhill Research’s ClearMate device that assists in treating patients with carbon monoxide poisoning, according to an FDA press release.
ClearMate — a novel device consisting of hoses, mask, oxygen reservoir, breathing circuits, gas mixer, meters and valves — delivers 100% oxygen and a combination of oxygen and carbon dioxide to the patient, allowing faster breathing, the release stated. The device speeds up the rate carbon monoxide leaves the patient’s body and allows a normal amount of oxygen to attach to hemoglobin and be delivered to where it is needed throughout the body.
“While the current standard treatment of administering 100% 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.,” Malvina Eydelman, MD, director of the division of ophthalmic, and ear, nose and throat devices in the FDA's Center for Devices and Radiological Health said in the release.
“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,” she continued.
The FDA granted authorization based on data that showed ClearMate was effective at eliminating carbon monoxide in 100 patients. These patients also did not experience any device-related complications.
ClearMate was reviewed as part of the FDA’s De Novo premarket review pathway process.
Disclosure: Eydelman works for the FDA.