ALung Technologies Receives CE Mark Approval for Hemolung Respiratory Assist System
PITTSBURGH— ALung Technologies, Inc., a leading developer of innovative respiratory assist devices, announced today that it has received CE Mark approval for its Hemolung Respiratory Assist System (RAS). Receipt of the CE Mark allows the Hemolung RAS to be sold in the European Union.
The Hemolung RAS 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 its European-based clinical trial of the device in 2011 and has been working with regulators to secure market clearances. The Company has also been granted a Health Canada License.
“The Hemolung RAS is the first device to provide simple, efficient, low-flow extracorporeal carbon dioxide removal for patients with acute respiratory failure,” said Peter DeComo, ALung’s Chairman and Chief Executive Officer. “We are excited to now be able to make this technology available to European intensive care units.”
ALung has been preparing for launch of the Hemolung RAS throughout Europe, establishing direct operations in Germany and the United Kingdom, and signing distributors in several other countries. A controlled launch is planned, with the device initially being made available to a select group of reference centers. A full commercial launch is slated for later this year.
The Hemolung RAS offers a simple, minimally invasive approach to extracorporeal carbon dioxide removal (ECCO2R) through use of a small venous catheter and techniques similar to renal dialysis. “The Hemolung approach is really innovative,” said Dr. Nicholas Barrett, Consultant in Critical Care at Guy’s and St. Thomas’ NHS Foundation Trust in London. “We see a lot of potential for devices like the Hemolung RAS in helping patients avoid the deleterious effects of invasive mechanical ventilation, either by avoidance of intubation or de-escalation of ventilator settings.”
About ALung Technologies
ALung Technologies, Inc. is a Pittsburgh-based developer and manufacturer of innovative lung assist devices. ALung’s Hemolung Respiratory Assist System (RAS) is a dialysis-like alternative or supplement to mechanical ventilation originally developed at the University of Pittsburgh. The Hemolung RAS provides Respiratory Dialysis® by removing carbon dioxide and delivering oxygen directly to the blood and is indicated for providing partial extracorporeal respiratory support in cases of acute hypercapnic respiratory failure, including acute respiratory distress syndrome (ARDS) and acute exacerbation of chronic obstructive pulmonary disease (COPD). A simple extracorporeal circuit, small venous catheter, and techniques similar to hemodialysis make the Hemolung RAS easy to use.
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