History
History of Glycar
Glycar is a medical device manufacturing company based in South Africa. The company was founded in 1992 by Prof. RWM Frater, who established our operations in the suburb of Irene, on the outskirts of the nation’s administrative capital, Pretoria. Prof. Frater was an internationally recognized cardiac surgeon who studied at the University of Cape Town and then moved to the United States of America where, for over 40 years, he worked at the Albert Einstein College of Medicine in the Bronx, New York. It was during his time at the Albert Einstein College that he conducted research into the use of bovine pericardium in cardiac surgery applications, with a particular emphasis on developing an anti-calcification treatment. The success of this research resulted in a line of surgical patches that exhibit an improved acceptance of the implanted material by the host, as well as minimal rejection.
Pericardial repair patches form the core of Glycar’s business, with six (6) patch sizes currently under production: 2x5cm (C0205) and 4x5cm (C0405) patches, 5x10cm (C0510), 9x14cm (C0914), 0.8x8cm (V0008) and Tapered 0.8x8cm (V0008T) patches. These patches are used for pericardial closure as well as cardiac and great vessel reconstruction and repair. Studies have shown that once implanted, the patches promote growth of the host’s endothelial cells over the structure of the patch. As a result, the patches are completely absorbed by the body in the long-term.
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Glycar has partnered with Saint Jude Medical (acquired by Abbott Laboratories in 2017) since 2001 for the world- wide distribution of the patches and Viking Medical for the local distribution in South Africa. Our products are all manufactured in compliance with the European regulations for medical devices (MDD93/42/EEC; MDD2007/47/EC and Commission Regulation 722/2012), as well as the US Food and Drug Administration (FDA) requirements for the manufacture of medical devices. As such our products all carry the CE (the European certification authority) mark. In addition, our Quality Management System is in accordance with, EN ISO 13485, MDR 2017/745 QMS requirements, and the FDA QSR 21 CFR Part 820. Regular audits/inspections are also carried out by DEKRA and the FDA in order to ensure compliance to these international standards.
Research forms an integral part of Glycar’s history, as well as our future, and as such we ensure that a portion of the proceeds from sales are donated to educational institutions, as part of our social responsibility program. Glycar has helped to fund the establishment of the RWM Frater Cardiovascular Research Centre at the University of the Free State. This initiative aims to ensure that ongoing research and development in the cardiovascular field is supported and helps to raise the quality of life of people across the globe.