EXTON, PA — Lungpacer Medical has unveiled promising results from its groundbreaking STIMULUS trial, a Phase 1 study conducted in collaboration with Toronto General Hospital. Presented at the 2025 Transcatheter Heart Therapies (THT) conference, the trial explored the use of diaphragm neurostimulation to enhance cardiovascular function in patients on invasive mechanical ventilation.
The innovative AeroNova System, central to the trial, combines a cardiovascular catheter equipped with stimulating electrodes and a software-controlled system to contract the diaphragm via transvenous phrenic nerve stimulation. By activating the diaphragm in sync with mechanical ventilation, the system aims to reduce ventilator-induced injuries to the lungs, heart, and other organs.
Key Findings
The trial enrolled 19 patients, with 16 undergoing stimulation procedures to assess diaphragm activation’s impact on hemodynamic performance. The findings revealed several key benefits when diaphragm neurostimulation was applied, showing strong potential to counteract the negative effects of positive pressure ventilation often seen in critically ill patients.
- Improved Heart Performance: Cardiac index and stroke volume index rose significantly (p=0.003 and p=0.016 respectively), indicating enhanced cardiac output and blood flow.
- Stabilized Blood Pressure: Mean arterial pressure increased markedly (p=0.002), suggesting better overall stability.
- Reduced Pulmonary Strain: Pulmonary artery pressure significantly decreased (p<0.001), driven by lower pulmonary vascular resistance—a crucial improvement for patients with pulmonary hypertension or cardiovascular compromise.
The results suggest a direct relationship between increased levels of diaphragm neurostimulation and improved cardiovascular and pulmonary outcomes, laying the foundation for further study.
Addressing a Critical Need
Diaphragm neurostimulation is known for helping with respiratory function, but its potential cardiovascular benefits during mechanical ventilation have largely been unexplored. The STIMULUS trial represents a major step forward in addressing this gap.
“In critically ill patients receiving mechanical ventilation, cardiac and circulatory performance can be significantly impaired by the effects of positive pressure ventilation,” explained Dr. Ewan Goligher, Associate Professor in the Interdepartmental Division of Critical Care Medicine at the University of Toronto and 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.”
Supporting Innovation in Intensive Care
Lungpacer Medical states that it is committed to advancing technologies that improve patient outcomes in intensive care. Its AeroPace System, already approved by the FDA in 2024, helps strengthen the diaphragm to facilitate weaning from mechanical ventilation—a critical milestone for many patients. The investigational AeroNova System builds on this foundation, offering the potential to reduce mechanical ventilation’s multi-organ impact while enhancing cardiac and pulmonary function.
With up to 2.5 million Americans requiring mechanical ventilation each year, accounting for $96 billion in care costs, Lungpacer’s solutions could deliver substantial benefits for patients and healthcare systems alike.
Looking Ahead
The STIMULUS trial demonstrates the potential of diaphragm neurostimulation as a novel therapy to address the challenges of critical care ventilation. The results also highlight the importance of innovation in reducing the risks of mechanical ventilation while improving overall patient outcomes.
Building on this success, Lungpacer Medical states that it will continue its efforts to refine and expand the applications of its AeroNova and AeroPace systems. By merging cutting-edge technology with clinical insights, the company aims to revolutionize care for critically ill patients, offering hope for better recovery pathways and enhanced quality of life.
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