Welcome to Glycar South Africa

History of Glycar

Glycar grew out of efforts to develop a new biologic  artificial mitral valve. The valve had a flexible ring attached to the annulus and and cordal flaps fastened to the papillary muscles. This was a revolutionary design that  imitated nature. The aldehyde tanned bovine pericardial tissue was treated with  propylene glycol which capped any residual unlinked aldehyde groups. This changed the tanned pericardium into a biocompatible material with minimal inflammatory reaction and very much reduced tendency to calcify when implanted into juveniles.

With the growth of mitral valve repair a market  for the valve was not developed. However the unique properties of the specially treated pericardium made it an excellent and superior  material for cardiovascular repairs. It was first used by cardiovascular surgeons in 1999. Its use has grown steadily with minimal promotion.

Glycar SA Pty Ltd was established in South Africa to manufacture the products. The company was registered in New York and Delaware. All business is conducted from South Africa with the finished product being exported directly to our single customer St Jude Medical in St Paul, Minnesota. Since 1999 St Jude has retailed the St Jude Pericardial Patch with EnCap in the USA, Europe and the Middle East. St Jude conducts supply audits periodically, most recently in 2012.

Our manufacturing facility is approved by the FDA and is inspected by the FDA periodically. The product is approved for US sale through the FDA 510k process. The product and our plant has CE approval and is inspected annually for adherence to ISO regulations by our German Notified Body for export. Approval pending in Canada and Japan.

The company has produced other products to order and has new products under development.

General Information on the Glycar Pericardium Patch