By Liz White, UT staffWilmington, Massachusetts-CardioTech International Inc. has applied to obtain the CE Mark for its CardioPass artificial coronary artery graft. The US group says the initial indication for use of CardioPass will be for “no-option” patients who are in need of a coronary artery bypass but do not have enough of their own native vessels for the necessary revascularisation. In such patients, the saphenous veins, radial arteries, and mammary arteries have often been used in previous bypass surgeries, or are too diseased to be utilised due to diabetes or other diseases, Cardiotech pointed out. CE marking indicates that a product complies with the essential requirements of applicable directives and has been assessed for conformity. It allows a device to be marketed within the European Economic Area (EEA). “There are currently thousands of ‘no-option’ patients who could benefit from the use of our CardioPass graft,” said Michael Szycher, chairman & ceo of CardioTech International, Inc. “With CE marking we will be able to sell CardioPass grafts throughout Europe and expedite approvals everywhere in the world, except the United Sates and Japan.”CardioPass is made using the firm’s patented ChronoFlex biodurable poly (carbonate) urethane. Szycher describes the graft as “compliant and pulsatile.” A final valuable feature is that it is “microporous to allow tissue in growth and encourage the formation of a stable neointinal lining-the end stage of the healing process,” he added. “These characteristics make us optimistic that CardioPass will be the first clinically successful synthetic coronary bypass in the world,” the CardioTech chief concluded. “
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