Reul H
Helmholtz-Institut of Biomedical Technology, Rheinisch-Westfälische Technische Hochschule, Aachen, Germany.
Thorac Cardiovasc Surg. 1999 Feb;47 Suppl 2:311-5. doi: 10.1055/s-2007-1013189.
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.
MEDOS/HIA心脏辅助装置的临床研发主要受同期动物实验结果的影响。研发过程中的一个重要步骤是新型三叶血泵瓣膜的构造，这使泵的动态血流有了显著改善。改良后的生产技术减少了血栓形成并发症，且在使用过程中操作更简便。不同尺寸的生产使得大量患者能够使用该装置。所有泵尺寸的有效性在确定性动物实验中得到了测试。向工业界转化的成果是一款已获批的产品，由一家创新型公司负责处理。自1994年2月起，MEDOS/HIA心脏支持装置已成功引入临床环境，截至1997年底已应用于217例患者。
