The European Commission has granted Linde Healthcare a new indication for their INOmax® Therapy for use during cardiac surgery, as a treatment for peri- and post-operative pulmonary hypertension in adults and children of all ages.
INOmax®, available in Europe since 2001 for term and near-term neonates with hypoxic respiratory failure, was the first medical gas to be approved as a drug through the European Medicines Agency (EMA).
Over a million heart surgery operations take place in Europe each year. During cardiac surgery, it is common for patients to experience an increase in blood pressure (hypertension) in the pulmonary arteries, which carry blood from the heart to the lungs. This reduces oxygen delivery to body tissues. Clinical trials have shown that INOmax® reduces this increase in pulmonary artery pressure, which in turn improves blood circulation and oxygen levels.
Dr Christian Wojczewski, Head of Linde Healthcare, said:
“Linde Healthcare is pleased that the European Commission has confirmed that INOmax® is a safe and effective treatment for heart surgery patients. We believe patient safety cannot be comprised and have a long heritage and commitment to improving healthcare, with a wide range of products addressing clinical needs across various therapeutic areas.
“This news will provide reassurance to doctors and nurses that they are treating patients with an approved drug product and that they have access to a total therapy package, with our staff on hand to provide ongoing training and support.”
The European Commission approval of the new indication for INOmax® applies to all 27 European Union member states, plus Norway, Iceland and Liechtenstein.