Admedus Ltd (ASX:AHZ) has had its CardioCel transcatheter aortic valve replacement (TAVR) devices validated through the publication of an independent study assessing the technology’s performance in peer-reviewed journal The Annals of Thoracic Surgery.
The article, “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.
It also shows that CardioCel performs comparably on the systemic and pulmonary circulations with no evidence of patch calcification, with 96% of patients free from reintervention at three and five years.
Admedus chief medical officer Dr Kiran Bhirangi said the results of the study were overwhelmingly positive for the medical technology company.
He said that it reinforces the evidence that ADAPT biomaterial scaffold tissue has superior durability.
Bhirangi added: “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.”
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The primary endpoint of the study was freedom from trans-catheter or surgical implant-related reintervention.
Secondary endpoints included interoperative and perioperative mortality, calcification, infection and thrombosis.
These 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.
The article also discussed the cost-benefit analysis of CardioCel, highlighting it as a cost-effective solution compared with other bioscaffolds, due to the reduced need for repeat surgery and improved quality of life.
Admedus chief executive officer Wayne Paterson said the study reinforced the clinical superiority of CardioCel, which used the company’s proprietary ADAPT tissue.
He added: “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.”
CardioCel performance was consistent across the three patient groups which were: babies 28 days and younger, infants aged from one month to one year and children older than one year.
The study collected data over five years 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.