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Lungpacer Medical Receives FDA Emergency Use Authorization to Wean Patients Off Mechanical Ventilation During Covid Crisis
April 29, 2020
Lungpacer Medical announced today that the U.S. Food and Drug Administration has issued Emergency Use Authorization (EUA) for the Company’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.
“We are thrilled to hear about the FDA’s decision to grant an EUA for the Lungpacer DPTS. 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. We are looking forward as an institution to start using this technology to help our patients during this pandemic,” noted Ali Ataya MD, Assistant Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Florida Health, Gainesville. Dr. Ataya also recently 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 (CVC), similar to central lines currently placed in mechanically ventilated ICU patients. The unique 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 (also known as Ventilator Induced Diaphragm Disfunction (VIDD)), 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 (VILI), 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.
“The COVID-19 pandemic, also known as SARS-COVID-2, has stimulated tremendous innovation to improve outcomes for these patients,” said Doug Evans, CEO Lungpacer Medical, Inc. “I am very proud of the Lungpacer team who have worked diligently to make this therapy available in a very short period of time, and I want to thank the FDA for their timely review and support. We are excited for the opportunity to provide healthcare professionals with access to the Lungpacer therapy to help their critically ill patients.”
Written by: Lungpacer Medical
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