• No evidence of calcification 8 years’ post-implantation in follow up to phase II CardioCel trial
• All patients are progressing well, and no repeat procedures have been required
• Longest reported data from a CHD pediatric clinical study to date
Brisbane, Australia 22 August 2016
Admedus Limited (ASX: AHZ) has today announced positive long-term data from its Phase II extension study for the repair of congenital heart defects in paediatrics using CardioCel. All patients continue to progress well, with no sign of calcification or need for repeat procedures.
The lead patient has now been implanted for 8 and a half years, another four patients for over 7 years, another six for over 6 years and three for greater than 5 years. The procedures range from ventricular septal defects (VSD) through to complex reconstructions like the Rastelli procedure, illustrating the broad application of CardioCel in congenital heart defect repairs and reconstructions.
“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,” said Mr Wayne Paterson, Chair and interim CEO.
This is the longest term reported follow up data from a clinical study in congenital defect pediatric patients. The data confirms 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.
“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,” said Mr Paterson.
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.
• All patients are progressing well, and no repeat procedures have been required
• Longest reported data from a CHD pediatric clinical study to date
Brisbane, Australia 22 August 2016
Admedus Limited (ASX: AHZ) has today announced positive long-term data from its Phase II extension study for the repair of congenital heart defects in paediatrics using CardioCel. All patients continue to progress well, with no sign of calcification or need for repeat procedures.
The lead patient has now been implanted for 8 and a half years, another four patients for over 7 years, another six for over 6 years and three for greater than 5 years. The procedures range from ventricular septal defects (VSD) through to complex reconstructions like the Rastelli procedure, illustrating the broad application of CardioCel in congenital heart defect repairs and reconstructions.
“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,” said Mr Wayne Paterson, Chair and interim CEO.
This is the longest term reported follow up data from a clinical study in congenital defect pediatric patients. The data confirms 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.
“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,” said Mr Paterson.
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.
