ALung enrolls pivotal Trial of Hemolung RAS for US Market
ALung Technologies asserted that it has initiated enrolling patient in its VENT-AVOID Trial of the Hemolung RAS. The Minneapolis Heart Institute Foundation recently enrolled the first study subject at Abbott Northwestern Hospital in Minneapolis, Minnesota. The VENT-AVOID Trial is the world’s first pivotal trial of extracorporeal carbon dioxide removal (ECCO2R) for treating patients with COPD exacerbations.
Peter DeComo, Chairman and CEO of ALung said “We are very grateful for their efforts to enroll their first patient and look forward to their continued participation in the study.”
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. COPD patients suffering severe exacerbations are potentially 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.
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%.