Updated on 11 February 2014
Singapore: Australia based Admedus has received FDA clearance to market CardioCel in the US.
CardioCel is the group's lead regenerative tissue product to repair and treat a range of cardiovascular and vascular defects. The Company will now look to complement its existing product launch in Europe with preparation for initial sales in the US.
The intended use of CardioCel in the US is in pericardial closure and for the repair of cardiac and vascular defects in both adults and paediatrics.
"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." said Mr. Lee Rodne, CEO, Admedus.
"CardioCel is an important addition to the surgeon's armoury in the treatment of congenital heart disease, as well as for the repair of heart valves and other cardiac defects" he said.