FDA grants EAP designation for ALung’s Hemolung respiratory assist system

5 November 2015 (Last Updated November 22nd, 2018 11:20)

The US Food and Drug Administration (FDA) has granted expedited access pathway (EAP) designation and priority processing status for ALung Technologies' Hemolung respiratory assist system (RAS).

The US Food and Drug Administration (FDA) has granted expedited access pathway (EAP) designation and priority processing status for ALung Technologies' Hemolung respiratory assist system (RAS).

ALung is a provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure.

The company developed Hemolung RAS to provide respiratory dialysis by removing CO2 directly from the blood, helping the speedy recovery of patients with acute respiratory failure.

In the US, chronic obstructive pulmonary disease (COPD) is the third leading cause of death.

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 (CO2) can result in respiratory failure and the need for intubation and mechanical ventilation as life saving measures.

"The EAP designation further validates that the current standard of care for COPD patients experiencing acute exacerbations can be improved."

The company noted the Hemolung technology aims to avoid or reduce the need for intubation and ventilator support by directly removing carbon dioxide from the blood.

The FDA designed the new EAP programme to facilitate rapid patient access to breakthrough technologies intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.

The device needs to meet one or more criteria, demonstrating it addresses an unmet clinical need, to qualify for the programme.

ALung Technologies chairman Peter DeComo said: "The EAP designation further validates that the current standard of care for COPD patients experiencing acute exacerbations can be improved.

"As one of the first companies selected for this programme, we look forward to working with the FDA to make the Hemolung technology available in the US as soon as possible."

The Hemolung RAS, which secured CE Mark in 2013, is approved in 34 countries outside of the US, including Europe, Canada and Australia.

In June, the company secured CE Mark approval for its new Hemolung XG4 cartridge and catheter kits, which were designed for use under Hemolung RAS to provide respiratory dialysis.