TransAeris Diaphragm Pacing System Gets FDA Emergency Use Authorization

As hospitals face the possibility of ventilator shortages for COVID-19 patients, Synapse Biomedical announced that it received FDA Emergency Use Authorization for a device that helps wean patients off ventilators quicker. This, in turn, could free up ventilators for use by other patients.

Weaning off of mechanical ventilation is a constant challenge in intensive care units, as prolonged ventilation can lead to diaphragm disuse atrophy and ventilator-induced diaphragmatic dysfunction (VIDD). VIDD makes it harder for patients to return to breathing on their own and increases ventilation time.



TransAeris helps to prevent or reduce severity of VIDD by conditioning a patient’s diaphragm. It consists of electrodes plus an external stimulator. Up to two electrodes are surgically implanted into the right and left hemi-diaphragms each, and the stimulator provides neuromuscular electrical stimulation to the diaphragm. The electrodes are removed after patients successfully comes off of mechanical ventilation.

The company touts that TransAeris can reduce mechanical ventilation time by 26 percent, which would result in ventilators becoming available to more patients. The system has received CE Mark approval and is currently under clinical investigation in the U.S.

“More than 2,000 patients have been successfully treated world-wide with our diaphragm, pacing technologies,” said Anthony Ignagni, President & CEO of Synapse Biomedical, in the announcement. “We welcome the FDA’s leadership in providing this emergency pathway to get our latest TransAeris device into the hands of clinicians so they can help as many COVID-19 patients as possible during this pandemic.”

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