Pittsburgh-based ALung Technologies has gained Health Canada approval for its Hemolung Respiratory Assist System (RAS), designed for treating patients with acute hypercapnic respiratory failure including acute respiratory distress syndrome and acute exacerbation of chronic obstructive pulmonary disease.
The minimally invasive device, which utilizes a small venous catheter and techniques similar to renal dialysis, offers a minimally invasive approach to extracorporeal carbon dioxide removal (ECCO2R) and for delivering 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."
Commercialization activities for the global launch of the device in 2013 have also been started, claims the company.
ALung said before making Hemolung RAS available in Canada, it will allow a selected group of Canadian hospitals to have early access to the device, through its Hemolung Reference Center 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 signed agreements with distributors in several other key European markets.
ALung, which has completed its European-based clinical trial of the Hemolung RAS in 2011, anticipates that it has been working with regulators to secure market clearances in Europe.