The European Union has granted CE mark approval to ALung Technologies' Hemolung Respiratory Assist System (RAS) for the treatment of patients with acute hypercapnic respiratory failure including acute respiratory distress syndrome and acute exacerbation of chronic obstructive pulmonary disease.
The minimally invasive device uses a small venous catheter and techniques similar to renal dialysis and offers a minimally invasive approach to extracorporeal carbon dioxide removal (ECCO2R) and for delivering oxygen directly to the blood.
ALung Technologies chairman and chief executive officer Peter DeComo said, "We are excited to now be able to make this technology available to European intensive care units."
The company, which has established direct operations in Germany and the UK and signed distributors in several other countries, is planning for a controlled launch with the device initially being made available to a select group of reference centers.
In addition, a full commercial launch of the device is scheduled later in 2013.
