The MitraClip Medical Device, Created to Avoid Open-Heart Surgery & its Controversial Journey Through the FDA

Research funded by the manufacturer of the device has faced scrutiny for years. In 2013, an external FDA advisor likened certain data presented in favor of its approval to being of low quality. Despite conflicting results from another study, the FDA extended its approval of MitraClip to a broader patient population in 2019, primarily based on a clinical trial where Abbott played a significant role. Despite three recalls, the first of which highlighted potentially life-threatening risks, neither the manufacturer nor the FDA withdrew inventory from circulation.

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