Lungpacer Medical Inc, a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, has enrolled the first patients in the Phrenic ACtivation for Enhanced Respiration (PACER) early feasibility trial. The PACER feasibility study was designed to determine initial safety and early feasibility of the Lungpacer IntraVenous Electrode (LIVE) Catheter and the diaphragm pacing method. To date, five patients have been successfully tested in the company’s First in Human (FiH) feasibility trial.
The Lungpacer system is designed to activate the diaphragm using a temporary, minimally invasive, transvascular nerve stimulation approach that is expected to save many lives, improve patient outcomes and greatly reduce hospital care costs, according to the company.
Mechanical ventilation (MV) can be life-saving for many critically ill patients. However, MV can also be harmful to the patient as continued MV and sedation interrupt the normal activation of the diaphragm muscle, which then atrophies rapidly and profoundly (known as Ventilator Induced Diaphragm Dysfunction; VIDD). In addition, positive-pressure invasive ventilation can damage the lungs (Ventilator Induced Lung Injury; VILI) and is associated with Ventilator-Associated Pneumonia (VAP).
The company reports that initial results are encouraging. The Lungpacer system demonstrated good functionality including the ability to reduce the mechanical ventilator pressure required to deliver breaths to the patients, consistent with the company’s pre-clinical data, according to a press release.
“We are excited about the initial results from the PACER early feasibility study, which supports the potential for Lungpacer’s novel therapy to help critically ill patients that are susceptible to ventilator induced diaphragm dysfunction and ventilator induced lung injury,” said Steven Reynolds, MD, regional medical director of Critical Care, Fraser Health Authority.
“Our team is thrilled with the initial outcomes from our FiH trial. Mechanical ventilator patients can struggle with regaining the ability to breathe independently following extended illness, and we look forward to exploring the potential for the LIVE Catheter to help these individuals regain the ability to breathe independently faster,” commented Doug Evans, President and CEO.
Lungpacer is an investigational device only and is not for sale in any country.