Lungpacer Medical has received approval for an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) for its STARI (STimulation to Activate RespIration) clinical trial. The Phase 2 feasibility study will evaluate the company's investigational AeroNova® System in patients suffering from moderate to severe Acute Hypoxemic Respiratory Failure (AHRF).
The AeroNova System represents a novel approach to mechanical ventilation, designed to deliver continuous diaphragm neurostimulation simultaneously with ventilator support. This minimally invasive medical device aims to mitigate the harmful effects of positive-pressure mechanical ventilation and reduce the risk of multi-organ ventilator-induced injury, potentially protecting the diaphragm, heart, brain, and lungs.
Innovative Approach to Mechanical Ventilation Complications
The STARI trial (NCT06832306) will specifically explore the potential of transvenous diaphragm neurostimulation-assisted ventilation (DNAV) in mechanically ventilated patients with moderate-to-severe AHRF. Through DNAV, the AeroNova System provides bilateral diaphragm activity that allows reduced positive pressure from the ventilator while maintaining patient respiration.
"This is an important step in advancing our AeroNova System, which represents a new frontier in ventilator therapy," said Doug Evans, CEO of Lungpacer Medical. "The STARI trial will provide critical insights into how diaphragm neurostimulation can benefit patients with AHRF and may ultimately reshape the way we treat patients requiring mechanical ventilation."
Mechanical ventilation, while life-saving, can lead to significant complications including diaphragm atrophy and dysfunction. These complications often contribute to prolonged ventilator dependence and increased mortality. The AeroNova System's approach could potentially address these issues by maintaining diaphragm function during mechanical ventilation.
Addressing a Significant Healthcare Burden
Mechanical ventilation affects approximately 2.5 million U.S. patients annually, with direct care costs reaching up to $96 billion. Lungpacer's technologies aim to decrease ventilator-associated injury and improve weaning outcomes for patients recovering from respiratory failure.
The study is being funded in part with federal funds from the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00021. This support highlights the potential application of diaphragm stimulation technologies in addressing national health security threats that can lead to AHRF or more severe respiratory outcomes.
Building on Previous Success
The AeroNova System builds upon Lungpacer's AeroPace® System, which received premarket approval (PMA) from the FDA in December 2024. The AeroPace System is approved to improve weaning success—increasing weaning rates, reducing ventilator days, and decreasing reintubation—in patients 18 years or older on mechanical ventilation for 96 hours or more who have not yet weaned.
While the AeroPace System stimulates the diaphragm twice daily to strengthen it and facilitate weaning, the investigational AeroNova System takes a different approach by providing continuous stimulation synchronized with mechanical ventilation to potentially prevent injury in the first place.
Clinical Trial Details
The STARI trial represents a critical step in evaluating whether continuous diaphragm neurostimulation can effectively reduce ventilator-associated complications and improve outcomes for patients with AHRF. The trial will focus on feasibility measures while gathering important safety and efficacy data.
If successful, this approach could significantly impact clinical practice for mechanically ventilated patients, potentially reducing complications, shortening ICU stays, and improving survival rates for critically ill patients requiring respiratory support.
The AeroNova System is currently limited by Federal law to investigational use exclusively for clinical investigations, while the company continues to gather evidence of its safety and efficacy through the STARI trial.
