Emergency Use Authorization

 

 

 

     Letter Granting EUA
 

   Fact Sheets

 



 
 

 

 

   Instructions for Use

 

 

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Corporate Headquarters

Lungpacer Medical Inc.
Suite 130, 601 W Cordova Street
Vancouver, B.C. V6B 1G1
Canada

USA

Lungpacer Medical USA Inc.
260 Sierra Drive, #116
Exton, PA 19341
USA


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: http://lungpacer.com/emergency-use-authorization.

For more information visit https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations.



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.