VANCOUVER, British Columbia, April 14, 2020
Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that the FDA has approved the Emergency Use Authorization for the use of the Lungpacer Diaphragm Pacing Therapy System (DPTS) to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure. According to the FDA letter, “patients at high risk of weaning failure include COVID-19 patients requiring ventilation and [other] patients being mechanically ventilated for other high-risk conditions including post-cardiac and post-thoracic surgical procedures and medical ICU patients requiring prolonged ventilation.” The approval states that “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 CEO, Doug Evans, stated that “this amazing honor provides a unique opportunity to help improve outcomes for many patients affected by this global health crisis.”
Emergency Use Authorization. The Lungpacer System is authorized for emergency use in healthcare settings to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure off ventilators during the COVID-19 pandemic. The Lungpacer System has neither been cleared nor approved for the indication to assist in weaning patients off ventilators in healthcare settings during the COVID-19 pandemic; the Lungpacer System has been authorized for the above emergency use by FDA under an EUA; the Lungpacer System 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.