• CardioCel® now approved for valve and annular repair in Europe
• European label now more in line with US label, where CardioCel is already approved for valve repair and reconstructions
• CardioCel now in over 120 centres globally
• Label expansion part of the global strategy to position CardioCel as the leading bio-scaffold
Brisbane, Australia 9th November, 2015
Admedus (ASX:AHZ) has today announced that it 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 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 Admedus CEO Mr Lee Rodne.
Admedus is currently undertaking a post-approval clinical study with leading heart centres to further bolster the clinical data available for CardioCel to demonstrate the benefits to patients in whole valve reconstructions over bio-prosthetic valve replacement.
CardioCel is on market in Europe, USA, Canada, Hong Kong, Singapore and Malaysia and continues to be accessed in the Australian market through early access programs. Admedus is also working with its partner Genpharm in the Middle Eastern and Northern Africa (MENA) region for additional regulatory approvals as well as exploring new markets in Asia.
CardioCel was initially launched in Europe at the end of 2013 and has been implanted in over 3000 patients. This recent label extension will enable surgeons to use CardioCel to repair congenital heart defects, heart valve repairs and augmentations, as well as whole heart valve reconstructions. The European heart valve market is estimated to be worth over $1 billon.
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