EXTON, Pa., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Lungpacer Medical, a neurostimulation company dedicated to developing innovative interventional therapies to free patients from mechanical ventilation (MV) and preserve or improve diaphragm, lung, heart, and brain health, shared the results of the STIMULUS trial, a phase 1 clinical study undertaken in collaboration with Toronto General Hospital. The STIMULUS trial investigated the application of diaphragm neurostimulation to improve hemodynamic performance in patients on invasive mechanical ventilation. The results showing improvement in hemodynamic performance were presented at the 2025 Transcatheter Heart Therapies (THT) conference, a premier international gathering of experts in cardiovascular research and interventions.
Lungpacer Medical’s investigational AeroNova System comprises a cardiovascular catheter embedded with stimulating electrodes and a software-controlled system that contracts the diaphragm via transvenous phrenic nerve neurostimulation. The system is designed to achieve ventilation using lower positive pressures from the ventilator to mitigate ventilator-induced injury to the lung, diaphragm, heart, and brain of patients on mechanical ventilation.
The STIMULUS trial (NCT05465083) marks a significant milestone in the advancement of medical technologies designed to optimize patient care in intensive care units (ICUs). This single center study aimed to evaluate the safety and effectiveness of diaphragm neurostimulation, delivered via the investigational AeroNova System, in patients with acute hypoxemic respiratory failure or post-thoracic surgery respiratory failure. A key outcome of the study focused on measuring how diaphragm activation, when synchronized with mechanical ventilation, could improve cardiovascular function and mitigate the negative hemodynamic effects commonly seen with invasive mechanical ventilation.
Study Overview and Results
The study enrolled 19 patients of which 16 underwent a stimulation titration procedure, with the majority of patients 12/16 (75%) having pre-existing cardiac dysfunction and exhibiting a high incidence of right ventricular dysfunction and/or pulmonary hypertension. Using the AeroPace Catheter, transvenous bilateral neurostimulation was delivered safely using stimulation levels titrated to achieve diaphragm activation resulting in increasing levels of expiratory occlusion pressure. The study evaluated a range of cardiac outcomes at baseline compared to after treatment.
Key Findings:
- Cardiac Function Improvement: Increasing levels of diaphragm neurostimulation led to a significant increase in cardiac index (p=0.003) and stroke volume index (p=0.016), indicating better heart performance and enhanced blood flow.
- Enhanced Mean Arterial Pressure: The study demonstrated that mean arterial pressure rose significantly (p=0.002), supporting overall hemodynamic stability.
- Decreased Pulmonary Artery Pressure: The results also showed a decrease in pulmonary artery pressure (p<0.001), likely driven by reduced pulmonary vascular resistance. This reduction is crucial for patients with cardiovascular compromise and pulmonary hypertension, where the heart struggles to pump blood through the lungs.
The study results indicate that diaphragm neurostimulation merits further exploration as a novel therapy to counteract the harmful cardiovascular effects associated with positive pressure ventilation by improving cardiac function and pulmonary hemodynamics. The study suggests a dose-response relationship, where increasing stimulation correlates with further improvements in cardiac and pulmonary parameters, providing a strong foundation for future investigation.
The Impact of Diaphragm Neurostimulation
Diaphragm neurostimulation has long been recognized as a technique to assist with respiratory function, but its potential to improve cardiovascular performance during mechanical ventilation has not been fully explored – until now. The STIMULUS trial reveals that diaphragm neurostimulation using a minimally invasive catheter-based system can serve as an adjunct to ventilation strategies, helping to maintain or improve hemodynamic stability in these critically ill patients.
“In critically ill patients receiving mechanical ventilation, cardiac and circulatory performance can be significantly impaired by the effects of positive pressure ventilation,” said Dr. Ewan Goligher, an Associate Professor in the Interdepartmental Division of Critical Care Medicine at the University of Toronto and a Clinician Scientist at the University Health Network. “The STIMULUS trial results indicate that diaphragm neurostimulation shows promise in reversing the adverse effects of positive pressure ventilation, which may lead to improved outcomes for these very ill patients.”
About Lungpacer Medical, AeroPace and AeroNova
Lungpacer Medical is dedicated to developing minimally invasive technologies designed to reduce ventilator-induced injury and help patients wean off mechanical ventilation and breathe on their own. Lungpacer’s AeroPace System is used to stimulate the nerves that activate and exercise the diaphragm twice daily to strengthen the diaphragm and facilitate weaning from MV. The AeroPace System received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in December 2024 to improve weaning success – increase weaning, reduce ventilator days, and reduce reintubation - in patients ages 18 years or older on mechanical ventilation ≥ 96 hours and who have not weaned.
Lungpacer’s second product, currently in the investigational phase, the AeroNova® System, utilizes continual diaphragm stimulation in synchrony with mechanical ventilation and is designed to reduce injurious positive pressures from the ventilator to mitigate multi-organ ventilator-induced injury to patients on mechanical ventilation. AeroPace and AeroNova have the potential to help the nearly 2.5 million US patients who require mechanical ventilation every year, accounting for up to $96 billion annually in direct care costs.
Learn more at Lungpacer.com and connect on LinkedIn.
Contact: media@lungpacer.com
The AeroPace System is approved by the United States Food and Drug Administration to improve weaning success in adult patients on MV at least 96 hours and who have not weaned. The AeroPace System is not approved in any other country.
CAUTION: The AeroNova System is limited by Federal law (United States) to investigational use. Used exclusively for clinical investigations.
