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Synapse Biomedical has received the US Food and Drug Administration’s (FDA) emergency use authorisation (EUA) for its TransAeris DPS system that assists in weaning Covid-19 patients off of ventilators in healthcare settings.
The rise in the number of patients requiring prolonged mechanical ventilation (PMV) has lead to increased demand on hospital and ICU resources amid the Covid-19 pandemic.
The PMV patients are at the risk of developing ventilator-induced diaphragm dysfunction (VIDD), which further extends their ventilation.
Synapse Biomedical’s TransAeris system resolves this issue by conditioning a patient’s diaphragm to reduce or avoid VIDD. The company noted that the technology could reduce the ventilator burden in Covid-19 patients by 26%, ensuring the availability of more ventilators during the current crisis.
The system recently received CE Mark approval and is currently under clinical investigation in the US.
Synapse Biomedical president and CEO Anthony Ignagni said: “More than 2,000 patients have been successfully treated worldwide with our diaphragm, pacing technologies.
“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.”
TransAeris was initially developed to assist patients with prolonged mechanical ventilation on a temporary basis up to 30 days, simplifying the external features of the company’s NeuRx DPS system.
The NeuRx DPS system is FDA and CE Mark approved for people with Spinal Cord Injury (SCI) since 2008. It is claimed to have successfully reduced or eliminated the need for mechanical ventilation in such patients.