Lungpacer wins FDA IDE for AeroNova system
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.
