CE mark/Health Canada licence for Hemolung RAS
Alung Technologies has received CE mark approval and a marketing licence from Health Canada, for its Hemolung respiratory assist system (RAS), which provides respiratory dialysis by removing carbon dioxide and delivering oxygen directly to the blood, allowing a patient's lungs to rest and heal. The company completed a Europe-based clinical trial of the device in 2011 and has been working with regulators to secure market clearances.
Alung has been preparing for launch of the Hemolung RAS throughout Europe, establishing direct operations in Germany and the UK, and signing distributors in a number of other countries. A controlled launch is planned, with the device initially being made available to a select group of reference centres. A full commercial launch is slated for later in year 2013.
The Hemolung RAS offers a minimally-invasive approach to extracorporeal carbon dioxide removal through use of a small venous catheter and techniques similar to renal dialysis. The system is a dialysis-like alternative or supplement to mechanical ventilation, originally developed at the University of Pittsburgh. It is indicated for providing partial extracorporeal respiratory support in cases of acute hypercapnic respiratory failure, including acute respiratory distress syndrome and acute exacerbation of chronic obstructive pulmonary disease.