Clinical Trial Underway for the VentFree Respiratory Muscle Stimulator

Liberate Medical has begun enrolling patients in the PREVENT trial, a pivotal clinical study examining the VentFree Respiratory Muscle Stimulator. PREVENT is a randomized, sham-controlled, blinded trial that aims to determine whether VentFree reduces the duration of invasive mechanical ventilation in acute respiratory failure patients at risk of being difficult to wean.

“The initiation of patient enrollment in the PREVENT trial is a landmark event for Liberate Medical and innovation in critical care medicine. We are immensely grateful for the support of the US Department of Defense, our team and our clinical partners across the world for their outstanding contributions to the successful initiation of this important trial,” Liberate Medical CEO Angus McLachlan stated. “We especially want to thank the patients and their families for their participation in this trial.”
 
The VentFree Respiratory Muscle Stimulator is billed as the first and only non-invasive, breath-synchronized, neuromuscular electrical stimulator designed to reduce mechanical ventilation duration by improving expiratory muscle strength and cough. Reducing the time patients spend on mechanical ventilation should reduce the risks of prolonged mechanical ventilation, including hospital-acquired infections, deteriorated quality of life and death. The PREVENT trial follows two successful pilot randomized controlled trials that were completed in Europe and Australia. VentFree has U.S. Food and Drug Administration (FDA) Breakthrough Device Designation and FDA Emergency Use Authorization in the United States, and CE Mark authorization in the European Union.

“The PREVENT trial is poised to provide invaluable insights into prevention of ventilator-induced complications,” “The PREVENT trial is poised to provide invaluable insights into prevention of ventilator-induced complications. Our collaborative efforts, supported by the dedication of our participating sites, will potentially improve outcomes for mechanically ventilated ICU patients.” commented Dr. Timothy Girard, professor of Critical Care Medicine at the University of Pittsburgh and co-global principal study investigator. “Our collaborative efforts, supported by the dedication of our participating sites, will potentially improve outcomes for mechanically ventilated ICU patients.” 
 
PREVENT administrators plan to enroll 272 patients from 25 centers across the Untied States, European Union, and Australia. The first study patient was enrolled at the Prince of Wales Hospital in Sydney, Australia (principal investigator: Dr. David Collins), with the Baylor College of Medicine in Houston, Texas (principal investigator: Dr. Chris Howard), and Providence Regional Medical Center in Everett, Washington (principal investigator: Dr. Jacob Glaser) first to recruit U.S. patients. 
 
“With the PREVENT trial, we are on the brink of improving the way we support critically ill patients. The expiratory muscles are a critical yet underappreciated component of respiratory health, and this trial will highlight their significance,” said Dr. Leo Heunks, professor of Intensive Care Medicine at Radboudumc and co-global principal study investigator “As a long-standing collaborator with Liberate Medical, I am proud to be part of a trial that has the potential to change clinical care.”
 
The study is being funded by a $6.48 million grant from the U.S. Department of Defense through the Peer Reviewed Medical Research Program. 
 
Liberate Medical is a medical device company that develops neuromuscular electrical stimulation technology for patients with pulmonary disorders. The firm is based in Crestwood, Ky.