Lungpacer Medical Receives FDA Emergency Use Authorization for Novel, Non-implanted Device to Wean Patients Off Mechanical Ventilation During Covid Crisis
EXTON, Pennsylvania, April 28, 2020 /PRNewswire/ -- 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.[1]
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.[2],[3] 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."
EUA: Devices that meet certain criteria for safety, performance, and labeling have been authorized for emergency use. The Lungpacer Diaphragm Pacing Therapy System is authorized for use in healthcare settings to assist in weaning intubated patients determined by their healthcare provider to be at high risk of weaning failure off ventilators during the COVID-19 pandemic. Treatment is for a maximum of 30 days.
The Lungpacer DPTS has neither been cleared or approved for the indication to assist in weaning patients off ventilators in healthcare settings during the COVID-19 pandemic;
The Lungpacer DPTS has been authorized for the above emergency use by FDA under an EUA;
The Lungpacer DPTS has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About: Lungpacer Medical, Inc., headquartered in Vancouver, Canada, and with US offices in Exton, Pennsylvania, leads the focus on providing temporary, non-surgical, minimally invasive technologies to make mechanical ventilation more effective and safer.
Clinical Background: The FDA granted Lungpacer DPTS a Breakthrough Designation in 2016. The RESCUE 1 IDE feasibility trial in difficult-to-wean MV patients (N=11) established basic safety and deliverability. In Europe, RESCUE 2, a randomized controlled trial (N=110; 20 sites), compared Lungpacer therapy to Standard of Care and was completed in January 2020. RESCUE 3, a pivotal IDE adaptive randomized controlled trial in 236 to 376 subjects, was started at US sites in 2019. This pivotal study is enrolling at multiple sites across the United States and Europe.
[1] Ataya A, Silverman EP, Bagchi A, Sarwal A, Criner GJ, McDonagh DL. Temporary Transvenous Diaphragmatic Neurostimulation in Prolonged Mechanically Ventilated Patients: A Feasibility Trial (RESCUE 1). Crit Care Expl, 2020; 2:e0106 DOI: 10.1097/CCE.0000000000000106
[2] Boles J. Weaning from Mechanical Ventilation. Eur Respir J., 2007; 29:1033-56.
[3] Béduneau, G. Epidemiology of Weaning Outcome according to a New Definition. The WIND Study. Am J Respir Crit Care Med. 2017; 195(6):772-783
Key Words:
Central venous catheter (CVC)
COVID-19
Diaphragmatic Pacing Therapy System (DPTS)
Diaphragm strengthening
FDA Emergency Use Authorization (EUA)
Mechanical Ventilation
PACING
RESCUE 1
RESCUE 2
RESCUE 3
SARS-COVID-2
Ventilator Induced Diaphragm Disfunction (VIDD)
Ventilator-Induced Lung Injury (VILI)
Weaning
Direct Correspondence to:
Lungpacer Medical, Inc.
+1-484-350-4530
+1-778-655-2100
[email protected]
www.lungpacer.com
SOURCE Lungpacer Medical, Inc
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