Long-term data from a Phase II extension study for the repair of congenital heart defects in paediatrics using CardioCel (Admedus) shows that all patients continue to progress well, with no sign of calcification or need for repeat procedures. A press release reports that lead patient has now been implanted with CardioCel for eight and a half years, another four patients for over seven years, another six for over six years, and three for greater than five years. The procedures range from ventricular septal defects through to complex reconstructions such as the Rastelli procedure—illustrating the broad application of CardioCel in congenital heart defect repairs and reconstructions.
According to a press release, this is the longest term reported follow up data from a clinical study in congenital defect paediatric patients. The press release states that these data confirm a significant competitive advantage between CardioCel and other products currently used in in the congenital heart surgery market, and illustrates why CardioCel is a bio-scaffold of choice for surgeons and patients alike.
Wayne Paterson, chair and interim chief executive officer of Admedus, comments: “This is a significant progression in the congenital heart surgery market. It is well known that other tissue patches on the market can calcify within 18 months post-implantation in paediatrics, making the results from our long-term CardioCel study exciting. This is very important data as we continue to roll-out CardioCel globally, and push into the adult cardiac and vascular markets. We are confident that we have a best in class product and this data will assist our ongoing global sales push.”
CardioCel is marketed in the USA, Europe, Canada, Singapore, Hong Kong, Malaysia, Singapore and the Middle East and North Africa region (MENA) and is now on the market in New Zealand.