Admedus has announced that it has received Food and Drug Administration (FDA) clearance to market CardioCel in the USA. CardioCel is a regenerative tissue product for repair and treatment of a range of cardiovascular and vascular defects. Admedus will now look to complement its existing product launch in Europe with preparation for initial sales in the USA.
According to a press release, the intended use of CardioCel in the USA 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,” says Lee Rodne, chief executive officer of 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.”
Admedus is able to sell CardioCel in both Europe and the USA and will pursue market approvals in Asia and other jurisdictions, the press release reports.