Admedus has announced positive long-term data from the CardioCel phase II clinical trial assessing the efficacy and safety of the company’s proprietary bio-scaffold which has been implanted to repair congenital heart disease defects.
Importantly, there have been no repeat heart procedures related to CardioCel for the monitored patients in the study and there are no signs of CardioCel calcification. In this trial, 11 patients have now had CardioCel implanted for over five years with one patient being implanted with the device over seven years ago.
A total of 11 patients are now past five years post-implantation including one patient over seven years post-implantation, four patients over six years post-implantation and six patients over five years post-implantation. Admedus is also following another four patients who are past four years post-implantation.
Lee Rodne, chief executive officer of Admedus, commented, “This long-term follow-up data illustrates some of the key features of CardioCel that we believe make it the bio-scaffold of choice for the repair of congenital heart disease defects. Given that the first patient in this trial was treated over seven years ago and the patient is doing very well, we are particularly encouraged that there has been no requirement for repeat procedures and no evidence of calcification of the implanted device.”
Admedus and the participating hospital will continue to follow a number of patients from the phase II study through this extended programme.
“These results are very exciting given the fact that CardioCel show no signs of calcification after five plus years, especially since it is known that other tissues implanted in children tends to calcify rapidly, thus proving the effectiveness of the ADAPT tissue engineering process to produce bio-scaffold implantable tissue products like CardioCel. These are very important data as we expand the use of CardioCel into the adult cardiac and the peripheral vascular markets,” said Leon Neethling, inventor of the ADAPT technology and CardioCel.
CardioCel is currently used in over 90 centres globally and 42 are based in the USA, demonstrating a high level of adoption within the first 12 months within the market.