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TORAY INOUE PTMC BALLOON CATHETER TRAINING PROGRAM UNDER WAY

This article was originally published in The Gray Sheet

Executive Summary

TORAY INOUE PTMC BALLOON CATHETER TRAINING PROGRAM UNDER WAY following FDA approval of the firm's premarket approval application for the device on June 28. FDA approved the device "for percutaneous transvenous mitral commissurotomy in patients with hemodynamically significant mitral valvular stenosis resulting primarily from commissural fusion of the mitral valve cusps." The firm is selling the device to doctors who are trained in the use of the device on four to five patients. The firm also is requiring that the physicians perform at least 12-15 procedures per year in order to maintain proficiency.
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