05.14.14
The U.S. Food and Drug Administration has given Admedus Ltd. its blessing to market a regenerative tissue product in the United States that can repair and treat cardiovascular and vascular defects in adults and children.
“This is a significant milestone for the company,” Admedus CEO Lee Rodne said. “CardioCel is an important addition to the surgeon’s armory in the treatment of congenital heart disease, as well as for the repair of heart valves and other cardiac defects.”
Having won approvals for CardioCel from both the United States and Europe, Admedus now will work to enter the Asian market as well as other jurisdictions.
CardioCel is a cardiovascular scaffold that can be used to repair congenital heart deformities and more complex heart defects. The CardioCel scaffold potentially can be used to repair and reconstruct dysfunctional heart valves and valve leaflets, with longer term possibilities for use in the manufacture of replacement tissue heart valves. CardioCel provides surgeons with a tissue bio-implant that is durable, naturally flexible and easy to handle, according to the Australian company. The product was created using the company’s ADAPT technology, which allows animal tissue to be prepared for human use without calcification issues.
In Australia, CardioCel was approved for the correction of congenital heart defects in children. In FY 2013, the company booked revenue of $12,000 from sales of CardioCel, and six surgeons used CardioCel in “around 60” operations from October 2012 to June 2013.
“This is a significant milestone for the company,” Admedus CEO Lee Rodne said. “CardioCel is an important addition to the surgeon’s armory in the treatment of congenital heart disease, as well as for the repair of heart valves and other cardiac defects.”
Having won approvals for CardioCel from both the United States and Europe, Admedus now will work to enter the Asian market as well as other jurisdictions.
CardioCel is a cardiovascular scaffold that can be used to repair congenital heart deformities and more complex heart defects. The CardioCel scaffold potentially can be used to repair and reconstruct dysfunctional heart valves and valve leaflets, with longer term possibilities for use in the manufacture of replacement tissue heart valves. CardioCel provides surgeons with a tissue bio-implant that is durable, naturally flexible and easy to handle, according to the Australian company. The product was created using the company’s ADAPT technology, which allows animal tissue to be prepared for human use without calcification issues.
In Australia, CardioCel was approved for the correction of congenital heart defects in children. In FY 2013, the company booked revenue of $12,000 from sales of CardioCel, and six surgeons used CardioCel in “around 60” operations from October 2012 to June 2013.