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Lungpacer Medical, Inc. Announces FDA Approval of Emergency Use Authorization of the Lungpacer Diaphragm Pacing Therapy System to Help Address COVID-19 Pandemic

Burnaby, BC, May 20, 2020--(T-Net)--Lungpacer Medical, Inc., an SFU VentureLabs alumni and medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced 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."

About Lungpacer Medical

Lungpacer Medical Inc. is developing a novel therapeutic solution for preserving or restoring the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation. The proprietary Lungpacer system is designed to activate and exercise the diaphragm using a temporary, minimally invasive, transvascular nerve stimulation catheter that is "expected to save many lives, improve surviving patient outcomes and greatly reduce hospital care costs."

Intravenously inserted Lungpacer electrodes are designed to rhythmically activate the diaphragm. In critically ill 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.

These potentially beneficial effects of transvascular diaphragm pacing are expected to result in faster patient recovery, a shorter stay in intensive care, improved health outcomes and lower hospitalization costs.

Lungpacer Diaphragm Pacing Therapy™