The MEDOS/HIA system: development, results, perspectives.

The clinical development of the MEDOS/HIA cardiac-assist device was influenced mainly by the results of the concomitant animal experiments. An important step in the development was the novel construction of a three-leaflet blood pump valve, which led to a substantial improvement in the dynamic blood flow of the pump. A modified production technique led to a reduction of thrombotic complications as well as to improved handling during use. The production of different sizes provides access for a large number of patients. The effectiveness of all pump sizes was tested in conclusive animal experiments. Result of transfer to the industry has led to an approved product, which is being handled by an innovative firm. The MEDOS/HIA Cardiac Support Device has been introduced successfully into clinical settings since February 1994 and has been used on 217 patients until the end of 1997.