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Regarding "EvaHeart," the Left Ventricular Assist System, five harmful events resulting in death were reported among eighteen clinical trials conducted in Japan. The ventricular assist system was invented by a professor, while the Sun Medical Technology Research Corporation, whose representative officer is a family member of the professor, was established in order to put the system to practical use. The university, which the professor belongs to, has also conducted eight among eighteen clinical trials so far. These potential conflict of interest issues led us to submit a request to the MHLW.


<　Our Request Outline　>

1.　Create an MHLW task force to investigate whether the clinical trial of this medical instrument and its evaluation were carried out properly and correctly, in addition to setting up an inquiry concerning the conflict of interest among the professor (developer) , corporation staff and officers of participating medical centers in the clinical trials.

2.　Investigate the safety of LVAS-10 itself with regard to five cases resulting in death, because medical mistakes may be suspected in two cases in particular, one conducted at Tokyo Women's Medical University and the other at the National Cardiovascular Center.

3.　Provide information about these two issues to the public. Hold a public meeting about LVAS-10, and reflect the obtained results in reviews and in the approval of the new medical instrument.

　
640,1,0,2009/03/27,2009/09/25,1,'「注目情報」更新

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