Health Canada has granted a licence to ALung Technologies' minimally invasive device for treating patients with acute hypercapnic respiratory failure, including acute respiratory distress syndrome and acute exacerbation of chronic obstructive pulmonary disease.
Using a small venous catheter and techniques similar to renal dialysis, the Hemolung Respiratory Assist System (RAS) offers a minimally invasive approach to extracorporeal carbon dioxide removal (ECCO2R), and to deliver oxygen directly to the blood.
ALung Technologies president and chief business officer Nick Kuhn said; "Clinical interest in ECCO2R continues to build as intensive care physicians seek new ways to protect their patients from ventilator-induced lung injury and even from being placed on invasive mechanical ventilation altogether."
Commercialisation activities for the global launch of the device in 2013 have also been started, according to the Pittsburgh-based company.
Prior to making the Hemolung RAS available in Canada, ALung is allowing a selected group of Canadian hospitals to have early access to the device through its Hemolung Reference Centre Program.
In anticipation of obtaining the CE mark for the device, the company has also started establishing European operations in Germany and the UK, and has signed agreements with distributors in several other key European markets.
ALung, which completed its European-based clinical trial of the Hemolung RAS in 2011, said that it has been working with regulators to secure market clearances in Europe.