Australia-based Admedus has received US Food and Drug Administration (FDA) clearance to market CardioCel, an advanced cardiovascular scaffold designed to repair and treat a range of cardiovascular and vascular defects.
In the US, CardioCel, a ready-to-use, off the shelf product, has now been approved for use in pericardial closure and for the repair of cardiac and vascular defects in both adults and paediatrics.
CardioCel is engineered by the group's ADAPT tissue engineering process to be a durable, pure collagen scaffold that avoids calcification, supports native cell infiltration, growth and differentiation and promotes a regenerative healing process.
It offers key benefits over existing products in that it does not calcify like other tissue products and has shown to facilitate autologous tissue regeneration once surgically implanted, while retaining strength and natural elasticity.
According to the company, CardioCel, the group's lead regenerative tissue product, has the potential to prevent follow-up surgeries for patients because of its anti-calcification and regenerative properties.
Admedus CEO Lee Rodne said this is a significant milestone for the company as it expands into global markets and further develop its range of regenerative tissue products for commercialisation and sale.
"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," Rodne said.
CardioCel received the CE Mark allowing European launch in August 2013 and the company made its first sale there in November.
According to the company, the CE Mark allows for the repair and reconstruction of heart defects, including treating congenital heart disease and repairing heart valves in both children and adults.
In a major step for the company's expansion into global markets, Admedus will now look to complement its existing product launch in Europe with preparation for initial sales in the US.