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  • Editorial: Necessity Is the Mother of Invention: The Unofficial Pathway From Off-Label to Approved

    Interventional cardiologists are tasked with addressing a seemingly infinite diversity of pathology using a decidedly finite set of tools. The interventional cardiology toolkit has grown from basic balloons and stents to include filters, valves, clips, and plugs. At the same time, the breadth of the field has expanded immensely with the advent of structural heart disease interventions. To address the full spectrum of structural heart disease, interventional cardiologists frequently utilize devices “off-label,” a phenomenon that has increased with the proliferation of available devices. An unofficial pathway has developed with initial reports of off-label utilization leading to clinical studies and subsequent expansion of approved device indications ( Fig. 1 ).

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