EXTON, PA — Lungpacer Medical has announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for the STARI (STimulation to Activate RespIration) clinical trial. This pivotal trial will assess the feasibility of Lungpacer’s groundbreaking AeroNova® System in treating patients with moderate to severe Acute Hypoxemic Respiratory Failure (AHRF).
The AeroNova System is an innovative, minimally invasive device designed to deliver continuous diaphragm neurostimulation in conjunction with mechanical ventilation. By activating the diaphragm, the system seeks to minimize the negative effects of positive-pressure mechanical ventilation, which can contribute to ventilator-induced injuries affecting not only the lungs but also the diaphragm, heart, and brain.
Transforming Ventilator Therapy
The STARI trial, a Phase 2 feasibility study, will evaluate the potential of transvenous diaphragm neurostimulation-assisted ventilation (DNAV) in mechanically ventilated patients suffering from AHRF. The AeroNova System will induce bilateral diaphragm activity, reducing the reliance on harmful positive-pressure ventilation while maintaining respiration. By doing so, it aims to prevent complications commonly associated with prolonged mechanical ventilation and facilitate better outcomes for patients recovering from respiratory failure.
“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.”
Addressing an Urgent Medical Need
Mechanical ventilation remains a vital yet risky intervention for approximately 2.5 million patients in the U.S. annually. Prolonged use can lead to ventilator-associated injuries and complicate the weaning process. The AeroNova System, alongside Lungpacer’s FDA-approved AeroPace System, offers the potential to significantly improve treatment for AHRF by reducing these risks and improving patient outcomes.
Lungpacer’s innovative approach also has critical implications for national health security. The AeroNova System’s ability to support diaphragm stimulation could play a role in mitigating respiratory injuries stemming from public health emergencies.
Federal Support
The STARI trial is being supported by federal funding from the U.S. Department of Health and Human Services, with financial backing from the Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA). This funding highlights the government’s recognition of the AeroNova System as a promising solution for respiratory care challenges.
With the launch of the STARI trial, Lungpacer Medical continues to push the boundaries of ventilator therapy, offering promising advancements in the treatment of AHRF and other respiratory conditions.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.