FDA approves SFU professor's invention to help wean COVID-19 patients from ventilators
Simon Fraser University professor Andy Hoffer hopes the SFU spinoff company he founded, Lungpacer Medical Inc., will help save the lives of COVID-19 patients using mechanical ventilators—and get them off more quickly, so that more ventilators can be available for all critically ill patients.
The company has received Emergency Use Authorization (EUA) clearance by the U.S. Food and Drug Administration, paving the way for immediate use of its Diaphragmatic Pacing Therapy System (DPTS).
The system has been authorized for use among patients at a high risk of weaning failure from ventilators. Ventilators are used in intensive care units (ICU) to provide breathing support during treatment or as the patient’s body overcomes disease.
According to Hoffer, about 30 per cent of ventilated patients typically fail to wean and die in hospitals, but the death rate appears to be much higher for ventilated COVID-19 patients in the U.S.
Headquartered in Vancouver, with offices in Exton, Pennsylvania, Lungpacer has developed a temporary, non-surgical, minimally invasive technology to make mechanical ventilation more effective and safer
Hoffer, a professor in SFU’s Biomedical Physiology and Kinesiology (BPK) department and Lungpacer’s founder and lead inventor, says “A big problem with inflating the lungs using positive pressure to deliver oxygen is that high pressure causes ventilator-induced lung injury, and in COVID-19 patients this may compound the lung damage caused by the virus.
“In contrast, pacing the diaphragm distributes the breathed oxygen more evenly throughout the lungs and this helps protect the tissue from mechanical injury.”
A second problem is that mechanical ventilation sidelines the diaphragm muscle and causes it to rapidly atrophy, which is a major reason for failure to wean. “Pacing the diaphragm helps maintain or restore its size, strength and endurance, which is key to enabling successful weaning,” he says.
The diaphragm stimulation therapy is delivered through a central venous catheter (CVC), similar to central lines currently placed in mechanically ventilated ICR patients.
The unique central line is used to deliver both fluids and medications, while also incorporating electrodes that activate the diaphragm muscle, via transvenous phrenic-nerve stimulation.
The system’s goal is to enable and accelerate the recovery of ventilated patients, reduce the hospital care cost of critically ill patients, improve the lifespan and quality of life of survivors of mechanical ventilation and save ICU patients’ lives.
The company has met several clinical milestones to bring its device to market.
The FDA granted the Lungpacer DPTS an expedited access pathway (EAP) designation in 2016. The company has since completed two clinical trials including a randomized, controlled, multicenter study in Europe with 110 patients, and is currently enrolling patients in a pivotal trial to support FDA approval.
The company’s CEO, Doug Evans, based in Philadelphia, says “I am very proud of the Lungpacer team who have worked diligently to make this therapy available in a very short period of time.