Abstract
The use of a medical device in cardiovascular medicine according to the instructions provides maximum quality and safety, which has been clinically tested and then clinically evaluated. When you use a medical device and do not follow the instructions for use, you use a medical device off-label. Off-label use of a medical device can be seen not as an extension of the clinical use of a medical device, but also as a way of expanding scientific knowledge. Some off-label uses of a medical device provide positive health effects, and some do not. Two examples of off-label use in cardiovascular medicine are presented. While the off-label use of drug-eluting stents is commonly accepted, the off-label use of continuous left ventricular assist devices as continuous flow total artificial hearts provide very poor clinical results. Medical doctors and their patients should know which off-label use method works and which does not.
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Macku, D. (2019). Off-label Use of Medical Devices in Cardiovascular Medicine—When the Final Decision About the Safety and Effectiveness Is Needed. In: Lhotska, L., Sukupova, L., Lacković, I., Ibbott, G. (eds) World Congress on Medical Physics and Biomedical Engineering 2018. IFMBE Proceedings, vol 68/2. Springer, Singapore. https://doi.org/10.1007/978-981-10-9038-7_1
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DOI: https://doi.org/10.1007/978-981-10-9038-7_1
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