Lungpacer Medical Accelerates Clinical Study With AeroPace System

Lungpacer Medical is using the AeroPace System, a next-generation product, in its RESCUE 3 pivotal clinical study to test faster ventilator independence. The RESCUE 3 study is the third in a series of studies to support U.S. Food and Drug Administration (FDA) and international regulatory approvals.
 
Lungpacer therapy has a Breakthrough Device designation and Emergency Use Authorization from the FDA. An abstract presented at the 2021 American College of Chest Physicians Annual Conference discussing Lungpacer therapy use on patients with COVID-19 under EUA reports that the therapy may assist in earlier liberation from mechanical ventilation. Outcomes from a previous Lungpacer clinical study published in the American Journal of Respiratory Critical Care Medicine showed Lungpacer therapy strengthened the diaphragm 246 percent more, and improved lung function 128 percent more than patients who did not receive the therapy.¹
 
The growing body of research including more than 44 scientific presentations and 11 peer reviewed publications is building evidence and data to demonstrate the value of AeroPace therapy. Lungpacer CEO Doug Evans stated, “The emerging research profile of AeroPace underscores the clinical potential of this therapy to play a meaningful role to limit the negative impacts of mechanical ventilation and restore strength for patients to achieve ventilator independence. Once approved, the AeroPace system has the potential to dramatically improve the standard of care and transform the future of ventilation.”
 
Without a strong diaphragm it is impossible to breathe independently² and artificial breathing support from a mechanical ventilator may weaken the diaphragm muscle more than 50 percent in one day.³ By delivering small stimulations to targeted nerves in the upper body to activate the diaphragm, the AeroPace System acts as a “personal trainer” for the diaphragm muscle. These daily, repetitive exercises are designed to build diaphragm strength and empower independent breathing, freeing patients from the trauma of mechanical ventilation. 
 
For the clinician, AeroPace provides easy setup for convenient patient therapy and ECG-guided catheter placement, streamlining the clinical workload. For the patient, automated electrode mapping, variable stimulation settings to adjust exercise intensity, and advanced patient synchrony with stimulation up to every breath are designed to customize therapy delivery and cater to patient comfort to accelerate the ventilator weaning process. 
 
Dr. Steven Conrad, a professor and Division Chief at Ochsner LSU Health and RESCUE 3 study principal investigator, noted, “The ability for the new AeroPace catheter to be placed either in the subclavian or jugular vein allows clinicians to utilize the best possible access for the patient as well as for therapeutic outcomes. We expect the automated mapping and therapy delivery features to cut our treatment time in half. AeroPace is a great new system, and we look forward to utilizing this technology more in the future.”
 
More than 40 highly respected medical centers in the United States, Germany, France, and Spain are currently participating in the pivotal RESCUE 3 trial studying faster ventilator independence with the Lungpacer therapy. Dr. Joseph Shrager of participating clinical site Stanford University School of Medicine said, “Lungpacer therapy provides an exciting potential solution to help mechanically ventilated patients return to natural breathing more quickly.”

Lungpacer Medical develops minimally invasive technologies designed to help patients wean off mechanical ventilation and breathe on their own. Lungpacer’s AeroPace System is designed to stimulate the nerves that activate and exercise the diaphragm to rebuild diaphragm strength and empower natural, independent breathing. AeroPace may potentially help the nearly 2 million patients that require mechanical ventilation every year, accounting for up to $96 billion annually in direct care costs. 

References 
¹ Dres, M., et al. Randomized Clinical Study of Temporary Transvenous Phrenic Nerve Stimulation in Difficult-to-Wean Patients, AJRCCM 2022 Feb 2. doi: 10.1164/rccm.202107-1709OC: 246% stronger diaphragm (MIP)/P=0.0010; +7.4% increased ventilator independence/P=0.586; 7.9% greater survival /P=0.216; 1.4 days less dependent on a ventilator/p=0.498. Modified Intent to Treat Subset (mITT), 128% improved lung function (RSBI)/P=0.102, Modified Intent To Treat Subset (mITT). 167% improved lung function (RSBI)/P=0.0487 in Per Protocol (PP) group received at least 50% of Lungpacer therapy sessions.
² Jubran A, Tobin MJ. Pathophysiologic basis of acute respiratory distress in patients who fail a trial of weaning from mechanical ventilation. Am J Respir Crit Care Med. 1997-155:906-15. doi: 10.1164/ajrccm.155.3.9117025.PMID:9117025.
³ Levine S, et al. Rapid Disuse Atrophy of Diaphragm Fibers in Mechanically Ventilated Humans. N Engl J Med. 2008 27 Mar: 358(13): 1327-35. doi: 10.1056/NEJMoa070447. PMID: 18367735.