At an FDA panel hearing held last week, SCAI Past President George Vetrovec, MD, FSCAI, testified on nonroller-type cardiopulmonary bypass blood pump devices, which include all peripheral ventricular assist devices. He urged the FDA panel to recommend against requiring that all of these devices go through the pre-market approval process, especially since they have already been approved via the 510k process. In his testimony, Dr. Vetrovec focused on how important it is for patients to have access to these potentially life-saving devices. Read more about the issue and read Dr. Vetrovec's testimony.
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