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Synapse Biomedical’s TransAeris Diaphragm Pacing System Gets FDA Emergency Use Authorization for Quicker Ventilator Weaning
April 16, 2020
Synapse Biomedical, Inc. has received an Emergency Use Authorization for the emergency use of its TransAeris® DPS, 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.
During the COVID-19 pandemic, the surge of patients requiring prolonged mechanical ventilation (PMV) has put an unprecedented demand on hospital and ICU resources. Even when their primary symptoms have stabilized, these PMV patients are still at risk for developing ventilator-induced diaphragm dysfunction (VIDD)—further prolonging their ventilation.
The TransAeris system addresses this issue by conditioning a patient’s diaphragm to reduce or avoid VIDD. Models suggest the technology—which recently received CE Mark approval and is under clinical investigation in the U.S – could reduce ventilator burden in COVID-19 patients by 26 percent, helping to free up more ventilators in a time of great demand.
“More than 2,000 patients have been successfully treated world-wide with our diaphragm, pacing technologies,” said Anthony Ignagni, President & CEO of Synapse Biomedical. “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.”
See Full Press Release: Synapse Biomedical, Inc. has received an Emergency Use Authorization for the emergency use of its TransAeris® DPS
Written by: Synapse Biomedical
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