Cardiocel
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CardioCel 1 is a cardiovascular repair product created in 2013 and sold by Australian small cap bio-pharm company, Admedus Ltd (ASX: AHZ), formerly Allied Healthcare Group (ASX: AHG).
In layman's terms, CardioCel is able to repair heart holes and deformities because it is patch made of bio-tissue taken from a cow's heart. The technology used in the product is far superior to older style heart repair products because it is more natural and readily accepted by the human body. The use of tissue cells replaces foreign substances such as titanium and carbon fibre which have been known to attract calcification. According to the company's own promotional material, CardioCel is a "bioscaffold used to repair congenital heart deformities and complex heart defects including repairing heart valves." 2
The CardioCel product is currently being used in over 60 medical centres globally to treat both adult and child patients in the USA, Europe and Asia. According to Admedus's Chief Operating Officer, Dr Julian Chick,“The first patient implanted in the Phase II study had a complex cardiac reconstruction using CardioCel® when they were only three weeks old and weighed just three kilograms. The patient, who is now six years of age, has no detectable calcification (using electrocardiograph imagery) in the implant and remains well." 3
Research conducted jointly by Admedus and CSIRO (Australia's Commonwealth Scientific and Industrial Research Organisation) shows excellent results 4. The Journal of Thoracic and Cardiovascular Surgery also published a study with excellent results. 5
§Competition[edit]
CoreValve is an artificial heart valve, manufactured by US company, Medtronic Inc. It's major selling point is that it is able to be inserted through a tiny incision in the groin by way of a catheter, hence eliminating the need for open-heart surgery on those whose health is too frail to undergo a major procedure. As of October 2013, the figures reported a quarter of all patients with the CoreValve implant died or suffered a major stroke within a year of the surgery. Although an improvement on previous surgery of this kind, this relatively high complication rate in itself, should not be seen as a reflection on the efficacy of the product as the patients using this product were very ill to start with. In addition to this, Medtronic was ruled to have infringed on another's competitor's patent. 6
Edwards Lifesciences' Sapien 3 Heart Valve is made of both bovine heart tissue and a cobalt chromium alloy frame (somewhat resembling chicken wire) 7 and is introduced into the body in the same manner as Medtronic's CoreValve - they won a patent lawsuit against Medtronic for infringement. As with CoreValve, Sapien is recommended only for patients who are unable to tolerate open heart surgery and has a high adverse event rate. 8
PhotoFix, manufacturer by Genesee BioMedical and distributed under license by Cryolife Inc (NYSE: CRY), is perhaps the most similar to CardioCel, as it is also made of bovine heart tissue and contains no artificial substances. Photofix sales began in January 2015 9 , trailing Admedus's February 2014 launch of CardioCel10 by 11 months.
§Future Applications[edit]
The ADAPT(R) technology used to manufacture CardioCel is also being developed for other uses with Admedus labelling it the first of a suite of implantable tissues.11
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