ALung Technologies, Inc. is a privately-held Pittsburgh-based developer and manufacturer of innovative lung assist devices.
Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation.
The Hemolung RAS has been approved outside of the United States since 2013 and is commercially available in major European markets. In September 2017, ALung received IDE Approval to conduct a pivotal clinical trial of the Hemolung RAS for the US Market.
COPD affects 30 million Americans and is the third leading cause of death in the United States behind cancer and heart disease.
Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. For patients with severe exacerbations, high levels of carbon dioxide can result in respiratory failure and the need for intubation and mechanical ventilation as life saving measures. Unfortunately, mechanical ventilation is associated with many side effects, and in-hospital mortality remains as high as 30%.
ECCO₂R therapy with the Hemolung RAS allows carbon dioxide to be removed from the blood independently of the lungs with the aim of facilitating the avoidance or reduction of intubation and invasive mechanical ventilation.
CAUTION: The Hemolung RAS is an Investigational Device and limited by United States law to investigational use.
The VENT-AVOID Trial is a prospective, multi-center, randomized, controlled, pivotal trial to validate the safety and efficacy of the Hemolung Respiratory Assist System for COPD patients experiencing an acute exacerbation requiring ventilatory support.
Forty hospitals will enroll up to 800 patients in the trial. The study protocol is built around a state of the art adaptive statistical plan which will allow for PMA submission when early success criteria are reached, potentially with as few as 300 patients enrolled. COPD patients suffering severe exacerbations will be eligible for the study if they are either 1) failing non-invasive ventilation and presenting a high risk of being intubated and mechanically ventilated or 2) have required intubation and invasive mechanical ventilation due to acute respiratory failure.
Trial enrollment is expected to begin during the winter of 2017-2018. Interested research centers can contact email@example.com for additional information about the study.