The FDA has granted emergency use authorization to Synapse Biomedical (Oberlin, Ohio) for its TransAeris diaphragmatic pacing stimulator to help wean COVID-19 patients off of ventilators.
TransAeris is the first system authorized by the FDA to perform such a task. The 30-day authorization is aimed at patients considered at high risk of weaning failure. It might also to reduce the risks to patients of prolonged mechanical ventilation and make more ventilators available to other patients during the pandemic, according to the agency. The device gained the CE Mark in 2018.
TransAeris is a temporary percutaneous intramuscular diaphragm stimulator indicated for use in the prevention and treatment of ventilator-induced diaphragm dysfunction. Prolonged mechanical ventilation can promote atrophy in the diaphragm and reduce its ability to contract, decreasing the likelihood of patients regaining the ability to breathe on their own.
The TransAeris system includes four intramuscular diaphragm electrodes, an external stimulator and the connectors that provide the interface between the electrodes and the stimulator. Once the patient is successfully extubated after mechanical ventilation, the electrodes are removed from the patient.
To avoid any transfer of nosocomial infections in the ICU environment, the entire system is disposed of after single-patient use.
