CardioCel: 8 years on and still free from calcification
23, August, 2016
CardioCel® is proving to be one of the biggest game changers in the congenital heart defect repairs and reconstructions space, offering significant long-term benefits to patients. While other tissue patches can calcify up to 18 months post implantation in paediatric patients, the latest follow up data released by Admedus shows no evidence of calcification using CardioCel a staggering eight years after surgery. With the potential for a product lifespan free from calcification, clinicians can potentially intervene earlier, and for the first time possibly provide patients with a life-long solution.
In a follow-up with 14 of the original 30 patients implanted with CardioCel in Admedus’ 2008 South Africa phase II trial, Admedus found all patients were progressing well and there was no sign of calcification, or need for repeat procedures. The lead patient has now been implanted for eight and a half years, which is unique in that there has never before been a study that has shown such a positive outcome over such a long period of time in a young cardiovascular surgical patient. Another four patients have progressed beyond seven years, another six for over six years and three for greater than five years, all showing no calcification, no repeat surgeries, and all are healthy. The surgical procedures in the study ranged from ventricular septal defects (hole in the heart), through to complex reconstructions like the Rastelli procedure, illustrating the broad application of CardioCel in congenital heart defect repairs and reconstructions. The results show 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.
CardioCel is the lead product range developed using Admedus’ proprietary ADAPT® technology, which transforms xenograft (animal) tissue into durable bio-scaffolds that can be used for soft tissue repair within patients.
Over the past five years, the team at Admedus has worked to refine the ADAPT process, resulting in the initial product CardioCel coming to market. The team is now looking to expand this product portfolio to include VascuCel®, an exciting new product for use in repair of vascular surgical procedures such as carotid endarterectomy (CEA), coronary revascularisation, vascular aneurism repairs and other vascular repairs. Admedus’ bio-manufacturing facility in Malaga will be ready to supply VascuCel alongside its current output of CardioCel by November 1st, 2016, addressing a market worth in excess of USD$500 million per annum.
CardioCel is approved for sale and used by leading heart centres in Europe, the US, Canada, Hong Kong, Malaysia, Singapore, New Zealand and Middle East and North Africa Region. CardioCel is also available under the special access scheme in Australia and other select countries.