FDA grants Emergency Use Authorization for novel, non-implanted device to wean patients off mechanical ventilation

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FDA has issued Emergency Use Authorization for Lungpacer Medical’s novel Diaphragmatic Pacing Therapy System (DPTS) for immediate use in patients on invasive mechanical ventilators at high risk of weaning failure, including COVID-19 patients.

“Hospital resources around the world have been under significant strain during the COVID-19 pandemic and ICU beds and mechanical ventilators have been at peak demand. This novel therapy has the potential to wean patients earlier from the ventilator and free up resources during these difficult times,” Ali Ataya, assistant professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Florida Health, Gainesville, said in a statement. “We are looking forward as an institution to start using this technology to help our patients during this pandemic.”

Ataya co-authored the publication reporting the results of the RESCUE 1 trial, which demonstrated feasibility, and assessed initial safety and efficacy of the Lungpacer DPTS.

Lungpacer DPTS is the first minimally invasive, temporary, transvenous phrenic-stimulation system cleared through Emergency Use Authorization by the FDA. This non-surgical, non-implanted, diaphragm stimulation therapy is delivered via a central venous catheter, similar to central lines currently placed in mechanically ventilated ICU patients.

The central line is used to deliver both fluids and medications, while also incorporating the capability to activate the diaphragm muscle via transvenous phrenic-nerve stimulation. This stimulation is intended to strengthen a weakened diaphragm, already atrophied by mechanical ventilation and is expected to help patients wean off the ventilator more rapidly.

Reducing time on the ventilator decreases the risk of ventilator-induced lung injury, secondary pneumonias, and poor patient outcomes associated with prolonged mechanical ventilation. Less ventilator time frees up ICU beds, resources and mechanical ventilators, potentially improving ICU throughput and effectively reducing ventilator burden by a projected 26% in patients during this COVID crisis.

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