EMA grants CardioCel a broader indication for use in Europe

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According to a press release, Admedus has received notification that CardioCel has been granted a broader indication for its use in Europe, from the European Medicines Agency (EMA). The product is now approved for use in the repair and construction of heart valves, expanding on its prior approval for use in the treatment of congenital heart defects. According to Admedus, this is more in line with permissions in the USA.

“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.” said Admedus CEO Mr Lee Rodne.

Admedus is currently undertaking a post-approval clinical study with leading heart centres to expand and improve the clinical data available for CardioCel. The company hopes to demonstrate the benefits to patients in whole valve reconstructions over bio-prosthetic valve replacement.

CardioCel is also on market in the 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. CardioCel is used in over 120 centres globally.

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