Lungpacer Medical announced today that it received FDA investigational device exemption (IDE) to begin a trial for its AeroNova system.
The STARI (stimulation to activate respiration) trial evaluates the feasibility of the investigational AeroNova system. It looks at the system in patients suffering from moderate to severe Acute Hypoxemic Respiratory Failure (AHRF).
AeroNova, a novel, minimally invasive medical device, delivers continuous diaphragm neurostimulation in tandem with mechanical ventilation. Lungpacer designed it to mitigate the harmful effects of positive-pressure mechanical ventilation. It could reduce the risk of multi-organ ventilator-induced injury.
The investigational AeroNova system includes a cardiovascular catheter embedded with stimulating electrodes. It features a software-controlled system that contracts the diaphragm through transvenous phrenic nerve neurostimulation
The Phase 2 feasibility study explores the potential of transvenous diaphragm neurostimulation-assisted ventilation (DNAV) in mechanically ventilated patients with moderate-to-severe AHRF. Through DNAV, AeroNova will deliver bilateral diaphragm activity. This 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.”
The company already offers the FDA-approved AeroPace system that delivers neurostimulation via an electrode-containing cardiovascular catheter and a software-controlled system. It delivers periodic phrenic nerve stimulation through the venous catheter. The system contracts and strengthens the diaphragm in patients on mechanical ventilation.
