- A device from Synapse Biomedical to help wean high-risk patients off of mechanical ventilation has received an emergency use authorization from FDA during the COVID-19 outbreak.
- The TransAeris Diaphragm Pacing System provides neuromuscular electrical stimulation to the diaphragm to prevent atrophy while the patient is relying on a ventilator to breathe.
- The agency cited modeling indicating 30% of patients hospitalized will require invasive mechanical ventilation or ECMO for an average of 10 days in the intensive care unit. FDA calculated that Synapse Biomedical's system could shorten the number of days spent attempting to wean the average patient from the ventilator to 2.6 days from four, reducing the overall ventilator burden in COVID-19 patients by 26%.
Guidelines from the American Association for Respiratory Care call for transitioning from mechanical ventilation as soon as a patient's underlying condition has improved to the extent that spontaneous breathing can be maintained safely. Less time on a ventilator also decreases the risk for secondary pneumonia.
There are no device treatments approved or cleared by FDA that can assist in weaning patients off of ventilators. In its April 13 letter to Synapse Biomedical, FDA said it believes, based on a review of the scientific evidence, that the company's device may help address concerns about ventilator availability during the pandemic, while also helping patients.
The TransAeris system, which gained a CE mark in 2018 and is in U.S. clinical trials, consists of an external electrical stimulator that connects to four electrodes temporarily implanted intramuscularly into the diaphragm. FDA said bench testing and reported clinical experience supported the agency's conclusion that the device may be effective in helping wean patients off ventilators in hospital settings during the COVID-19 emergency.
Synapse Biomedical, founded in 2002, sells the NeuRx Diaphragm Pacing System for the treatment of chronic respiratory insufficiency in people with spinal cord injuries and to provide diaphragm conditioning for patients with amyotrophic lateral sclerosis, or Lou Gehrig's disease. The NeuRx system, which received a humanitarian device exemption from FDA, was developed in collaboration with Case Western Reserve University and the University Hospitals of Cleveland.