Medtronic heart valves back on Japanese market:
This article was originally published in Clinica
Medtronic has reintroduced its Freestyle and Mosaic porcine-derived heart valves in Japan after halting sales there in October 2001 following new regulatory requirements. The company emphasised that its third-generation porcine tissue valves had not been withheld from the market for reasons of product quality or safety, but because the Japanese government introduced reporting regulations that are "unique in the world" requiring firms to track tissue from a single animal to implant. Medtronic can now do this; previously the devices were traceable to lots of around 20 animals.