Medical device and MedTech insights, news, tips and more

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.[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.”

See Full Press Release: Lungpacer Medical Receives FDA Emergency Use Authorization for Novel, Non-implanted Device to Wean Patients Off Mechanical Ventilation During Covid Crisis

Written by: Lungpacer Medical

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?

Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.