Lungpacer Medical, Inc., is a privately held medical device company focused on improving respiratory and critical care medicine. Headquartered in Vancouver, Canada, and with US offices in Exton, Pennsylvania, Lungpacer Medical is dedicated to designing non-surgical, minimally invasive technologies to ventilate patients more safely and effectively.
The Lungpacer Diaphragm Pacing Therapy System™ is the first, minimally invasive, temporary transvenous diaphragmatic neurostimulation system that has FDA Emergency Use Authorization (EUA) for use during the COVID-19 pandemic. This non-surgical, non-implanted, diaphragm stimulation therapy is delivered via a central venous catheter (Lungpacer IntraVenous Electrode - LIVE Catheter®), similar to catheters currently placed in mechanically ventilated ICU patients. The LIVE Catheter is intended to stimulate the diaphragm in conjunction with an invasive mechanical ventilator. This device is designed to strengthen a weakened diaphragm already atrophied by mechanical ventilation (also known as VIDD) which may help patients wean off the ventilator more rapidly.
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.
For more information on Emergency Use Authorization visit https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices.
