Admedus (ASX:AHZ) has received notification from the European Medicines Agency (EMA) that CardioCel has been granted a broader label indication for its use in Europe.
The new, expanded indication for CardioCel means the product is approved for use in the repair and reconstruction of heart valves, in addition to congenital heart defects, and is more in line with the US label.
The company said the expanded indication is a significant step in establishing CardioCel as the regenerative tissue product of choice for repairing and reconstructing heart valves and is part of the Group’s global strategy to drive sales growth. CardioCel is now used in over 120 centres globally.
“This is an important label expansion and will help us to increase the use of CardioCel in Europe, particularly in adult patients. We’re very excited to expand our work with surgeons and key heart centres in Europe and around the world on improving patient outcomes in treating heart valve disease by repairing and reconstructing heart valves with CardioCel,” said CEO Mr Lee Rodne.
Admedus is currently undertaking a post-approval clinical study with leading heart centres to bolster the clinical data available for CardioCel to demonstrate the benefits to patients in whole valve reconstructions over bio-prosthetic valve replacement.