Device to Assist in Weaning Patients Off Ventilators is Granted EUA

Synapse Biomedical has received Emergency Use Authorization for the use of a technology that could have big implications for patients using ventilators going forward.

The TransAeris DPS is used to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure off of ventilators in healthcare settings during the COVID-19 pandemic for no more than 30 days.

The Oberlin, OH-based company said the TransAeris system recently received CE Mark approval and that models suggest the technology could reduce ventilator burden in COVID-19 patients by 26%. This could, in turn, help free up more ventilators the company said.

TransAeris can help by conditioning a patient’s diaphragm to reduce/avoid ventilator-induced diaphragm dysfunction.

“Trauma and high-risk surgical and cardiac patients will continue to require ICU beds and ventilators that are also needed for COVID-19 patients,” Raymond P. Onders MD, FACS, Chief of General Surgery, University Hospitals Cleveland Medical Center and Professor, Case Western Reserve University School of Medicine, said in a release. "In our case, utilizing TransAeris for high risk surgical and COVID-19 patients is protecting the supply chain of ventilators, ICU beds and clinical resources by reducing the time spent on mechanical ventilators by patients at risk or experiencing prolonged mechanical ventilation."

The EUA comes tightly on the heels of General Motors shipping its first round of ventilators. Since the COVID-19 crisis hit the U.S. there has been concern over a shortage of potential ventilators. This shortage has caused automakers like GM to step in and produce the devices.

GM is under a nearly $500 million contract to mass-produce the Ventec Life Systems V+Pro critical care ventilator under contract to the U.S. Department of Health and Human Services.

In a release, GM said more than 600 ventilators will be shipped this month, almost half the order will be filled by the end of June and the full order will be completed by the end of August. GM noted it has the capacity to build more ventilators after August if needed. The contract was for 30,000 ventilators.