FDA grants EUA for device to wean patients off ventilators
The US Food and Drug Administration (FDA) this week granted an emergency use authorization (EUA) to Synapse Biomedical of Oberlin, Ohio, to permit the use of its TransAeris diaphragm pacing stimulator system to assist in weaning patients with coronavirus disease (COVID-19) off mechanical ventilation.FDA notes that it has not cleared or approved any medical devices for this use outside of the current public health emergency, though the TransAeris system is CE marked for such use in the European Union.
The EUA was granted “based on bench testing and reported clinical experience” indicating that the pacing system could reduce the risk of prolonged mechanical ventilation and help free up ventilators for other patients more quickly, according to FDA.
In granting the EUA, FDA notes that modeling indicates 30% of patients hospitalized for COVID-19 will require critical care involving mechanical ventilation or extracorporeal membrane oxygenation, with patients requiring about 10 days of ventilation. FDA says that if 40% of that time is spent trying to wean patients off ventilation, the TransAeris system could potentially shorten the time spent weaning from 4 days to 2.6 days.
Under the EUA, the TransAeris system may be used for no more than 30 days and must be supplied with fact sheets for health care providers and patients.
EUA, Press Release