Still no calcification in regenerative tissue technology

Biotechnology company Admedus has revealed that CardioCel, its collagen cardiovascular scaffold used to repair heart defects, has shown no detectable calcification or any other issues in the six years following implantation.

The first patient from the phase II study, initially implanted with CardioCel at three weeks of age, has successfully reached their sixth birthday with no implant issues. The results of the six-year follow-up show there is still no detectable calcification of the scaffold and no ‘redo’ surgery required.

“This is great progress for patients in not having to have additional surgeries and it represents huge potential for the future treatment of congenital heart disease and other cardiac defects,” said Admedus CEO Lee Rodne.

All other patients, who are examined for calcification and overall health annually, continue to show no signs of calcification or follow-up surgeries after three to five years. The company anticipates continued data from the ongoing monitoring of these patients.

CardioCel is the first of a suite of implantable tissues generated by Admedus’s ADAPT tissue engineering process, which develops biological scaffolds that mimic the characteristics of normal human tissue to promote a more tolerant immune response combined with improved tissue ingrowth.

The company recently received FDA clearance for CardioCel, allowing its marketing in the US. It was last year approved in Europe under a CE Mark.