Admedus has obtained the US Food and Drug Administration (FDA) clearance to market an advanced cardiovascular scaffold, CardioCel, which is designed to repair and treat a range of cardiovascular and vascular defects.
The approval is intended to use in pericardial closure and for the repair of cardiac and vascular defects in both adults and pediatrics.
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 which 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.
CardioCel is a ready to use, off the shelf product that 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 added.
The company will now look to complement its existing product launch in Europe with preparation for initial sales in the US and is a major step for the company’s expansion into global markets.