Mechanical ventilation (MV) although life-saving, can also be harmful:

  • MV and sedation cause the disused diaphragm muscle to atrophy rapidly and profoundly (ventilator induced diaphragm dysfunction; VIDD*)
  • Positive-pressure ventilation often damages the lungs (ventilator induced lung injury; VILI) and may lead to ventilatorassociated pneumonia (VAP)
  • MV requires intubation and depending on the injury or illness may require a tracheostomy whenever mechanical ventilation has to continue for a longer period of time
  • Ventilated patients are at high risk of contracting nosocomial (hospital-acquired) bacterial and fungal infections

* Levine S, Nguyen T, et al. “Rapid Disuse Atrophy of Diaphragm Fibers in Mechanically Ventilated Humans” N Engl J Med 358: 1327-35, 2008.

VIDD, VILI and VAP are key contributing factors to the frequent difficulty in weaning patients from the ventilator. About 31% of patients on MV are categorized as ‘difficult to wean’ when they fail one or more spontaneous breathing trials or need to be re-intubated within 48 hours of extubation.

About 35% of ventilated patients require prolonged weaning periods of over 96 hours, and over 20% are still on MV at 7 days. These are the most expensive patients in the hospital. The U.S. cost of prolonged MV patients in 2020 is projected to exceed $60 Billion**. When a patient becomes ventilator-dependent, their risk of dying in the ICU increases 7-fold.

** Zilberberg, Prolonged acute mechanical ventilation and hospital bed utilization in 2020 in the United States: implications for budgets, plant and personnel planning. BMC Health Services Research, 2008, 8:242.

Intravenously inserted LIVE Catheter is designed to rhythmically activate the diaphragm. In the patients who have failed or would typically fail to wean and become ventilator-dependent, the pacing therapy is expected to prevent or reverse diaphragm muscle-disuse atrophy and maintain diaphragmatic endurance, thus facilitating weaning of patients from MV. In addition, the paced diaphragm is expected to restore negative pressure ventilation, thereby potentially providing a more physiological respiratory pattern and reducing the levels of positive pressure ventilation and its harmful effects on the lungs.

The potentially beneficial effects of Lungpacer Diaphragm Pacing Therapy (DPT) are expected to result in faster patient recovery, a shorter stay in the intensive care unit, improved health outcomes and lower healthcare costs.

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Emergency Use Indication:

The Lungpacer DPTS has been authorized for emergency use in healthcare settings for treatment of patients on invasive mechanical ventilation who are at high risk of weaning failure, including COVID-19 patients, during the COVID-19 pandemic.

Important Safety and Effectiveness Information:

There are no FDA approved, licensed, or cleared device treatments to assist in weaning patients off of ventilators. Based on bench testing and reported clinical experience, FDA has concluded that the Lungpacer DPTS may be effective at treating patients during COVID-19 by helping wean patients off ventilators in healthcare settings, thereby reducing their risks of prolonged mechanical ventilation and increasing the availability of ventilators during the COVID-19 pandemic.

Lungpacer DPTS treatment is for a maximum of 30 days. Device-related serious adverse events reported in clinical trials were single events of pneumothorax and mucus plug liberation.

The LIVE Catheter component of the Lungpacer system has not been evaluated for safety when used with cardiac pacemakers or defibrillators and should be removed prior to Magnetic Resonance (MR) imaging. Duration: The Lungpacer DPTS is available under an Emergency Use Authorization for the duration of the COVID-19 pandemic.

Emergency Use Instructions for Use, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients are available at:

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Emergency Use Authorization Information:

This Diaphragmatic Pacing Stimulator has not been FDA cleared or approved.

This Diaphragmatic Pacing Stimulator has been authorized by FDA under an Emergency Use Authorization (EUA).

This Diaphragmatic Pacing Stimulator is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Diaphragmatic Pacing Stimulator Systems under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.