Admedus gets FDA approval for CardioCel
Admedus (ASX:AHZ) has won regulatory approval to market its CardioCel cardiovascular patch in the US.
The US FDA has cleared CardioCel for use in pericardial closure and for the repair of cardiac and vascular defects in both adults and children.
Admedus, which changed its name from Allied Healthcare late last year to give it a more distinctive brand internationally, secured a CE Mark for CardioCel in August, allowing it to market the product for the repair and reconstruction of heart defects including congenital heart disease.
“This is a significant milestone for the company as we expand into global markets and further develop our range of regenerative tissue products for commercialisation and sale,” Admedus CEO Lee Rodne said.
The company has announced plans to pursue more approvals in Asian and other international markets over the coming year.
In Australia, multiple surgeons have been granted approval to use CardioCel in procedures under the TGA’s Authorised Prescriber Scheme (APS).
Admedus produces CardioCel using its Adapt tissue engineering process. It has demonstrated the ability to avoid the risk of calcification that comes with some existing tissue products.
Admedus (ASX:AHZ) shares were trading 6.25% higher at $0.17 as of around 1.30 pm on Monday.
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