Shockwave Medical Inc. is aiming to establish a new standard of care for the minimally invasive treatment of atherosclerotic cardiovascular disease. Its intravascular lithotripsy (IVL) system uses sonic pressure waves to remove calcified plaque that narrows or blocks the blood vessels connected to the heart.
Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the agency, or perhaps more to the point, his lack of tenure. While it’s tempting to frame the question that way, it might be more salient to ask about the nature of the FDA commissioner’s job and whether it is still sufficiently politically insulated to do what is asked of it. Gottlieb had been on the job...
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