The Hemolung RAS is a dialysis-like alternative or supplement to mechanical ventilation for treating patients with acute respiratory failure, including those suffering from acute exacerbation of chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS). The TGA approval allows the Hemolung RAS to be used in more than 75 hospitals across Australia with level 3 intensive care units. The device also is cleared for use in Europe and Canada.
“Medtel is most pleased to gain this key regulatory step in making the Hemolung technology available to the intensive care clinicians in Australia," said Andrew Lehmann, managing director of Medtel Australia. "The Hemolung RAS is viewed as an innovative and market disruptive technology with the opportunity to provide patients with better outcomes and fewer lung complications. Medtel looks forward to partnering with ALung to promote and support the Hemolung product.”
TGA approval for the Hemolung RAS took approximately 12 months, ALung Technologies said. Before obtaining approval, three Australian hospitals evaluated the Hemolung RAS under a special Authorized Prescriber program to access innovative medical devices. Hergen Buscher, M.D., staff specialist for Intensive Care Medicine at St. Vincent Hospital in Sydney who participated in the evaluation program, said the Hemolung RAS improves the ventilation of critically ill patients by bypassing the life-threatening side effects of mechanical invasive ventilation.
“We are grateful for the support of Medtel, the Australian intensive care community, and the TGA as we worked through this approval process,” said Nicholas Kuhn, ALung president/chief business officer. “We are very excited to make the Hemolung RAS available to physicians all across Australia as they seek to optimize the care of their most critically ill patients.”
Based in Pittsburgh, Pa., ALung Technologies is a privately-held developer and manufacturer of lung assistance devices. Founded in 1997 as a spin-off from the University of Pittsburgh, ALung is backed by individual investors and venture firms including Allos Ventures, Birchmere Ventures and West Capital Advisors, LLC.
Medtel Pty Limited is a supplier of high-end technology products and services to the medical and allied health care industry, with sales and service offices located across Australia and New Zealand. Established in 1965, Medtel is part of The Getz Group of Companies, an international marketing and services company with more than 150 offices in 49 countries and six continents worldwide.