Hope for infants: Allied launches cardiovascular tissue patch CardioCel to surgically repair congenital heart defects
Singapore: Australian biomedical company Allied Healthcare launched cardiovascular tissue patch, CardioCel, to surgically repair congenital heart defects (CHD) in infants.
The surgery, performed at Brisbane's Mater Hospital, represents the first use of CardioCel outside of a clinical trial. The Therapeutic Goods Administration (TGA) last month authorized CardioCel's use for surgical repair of CHD under an Authorised Prescriber Scheme, allowing the authorized cardiothoracic surgeon to use the heart patches to treat their patients prior to full marketing approval.
"The use of CardioCel is expected to add significant long term value to our existing surgical practice of repairing CHD and is expected to allow our patients to live a 'normal' life, free of implanted tissue related complications," said Professor Tom Karl, who performed the surgery.
Ten years of preclinical and clinical studies have shown CardioCel patches have no evidence of toxic cell damage (cytotoxicity) or build-up of hard tissue at the site (calcification) for one to three years post-surgery.
Mr Lee Rodne, MD, Allied Healthcare Group, said that CardioCel provides a biocompatible scaffold for native tissue repair and also retains tensile strength, thereby addressing key problems associated with existing tissue matrix products.
