Admedus (ASX:AHZ) has announced the publication of an independent study assessing the performance of CardioCel in the peer-reviewed journal, The Annals of Thoracic Surgery.
The company said the manuscript, 'Multi-centre experience with 500 CardioCel implants used for the repair of congenital heart defects', delivers the positive finding that CardioCel has good durability in paediatric patients, performs comparably on the systemic and pulmonary circulations with no evidence of patch calcification, and shows 96 per cent of patients free from reintervention at three and five years.
"The performance was consistent across the three patient groups (babies 28 days and younger, infants aged from one month to one year and children older than one year)," said the company.
The study collected data over five years (October 2012 to November 2017) across 377 patients in Brisbane, and two UK sites (Bristol and Leicester).
It is the largest series of data collected on the use of CardioCel in humans. The primary endpoint of the study was freedom from implant related reintervention (transcatheter or surgical). Secondary endpoints included interoperative and perioperative mortality, calcification, infection and thrombosis.
"The secondary endpoints demonstrated an excellent safety and durability profile, with one case of thrombosis and one case of patch dehiscence (separation) recorded across the entire patient population," said the company. "There was no evidence of calcification through echocardiography or CT screening."
The manuscript also describes CardioCel as a cost-effective solution compared with other bioscaffolds, given the reduced need for repeat surgery and improved quality of life.
“The results of this study are overwhelmingly positive for Admedus. It reinforces the evidence that ADAPT tissue has superior durability," said Admedus chief medical officer Dr Kiran Bhirangi.
"It demonstrates, across a large patient population presenting with a range of disease types, that CardioCel provides a solution with few complications and minimal chance of required intervention. This is particularly relevant for paediatric patients who need to lead healthy and active lives, without the need for ongoing surgery.”
According to CEO, Wayne Paterson, “the study reinforces the clinical superiority of CardioCel which uses our proprietary ADAPT tissue. This large body of independent data, published in a highly respected peer-review journal, is a very important milestone. The data will support further market adoption not only for CardioCel but our entire ADAPT portfolio.
“It also reinforces the clinical and commercial potential of our 3D single piece aortic valve and TAVR devices in development. Each will have the same anti-calcification properties, key differentiators and improvement on existing solutions. We are now rapidly progressing towards first-in-human studies and look forward to providing an update in due course.”