Current cardiology reports
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Increasing barriers to medical device innovation in the United States including constrained financial resources and rising research costs require that physicians take on greater involvement in medical device development, evaluation, and regulatory processes. Such involvement requires that physicians understand basic aspects of the regulatory process for medical devices and recognize the myriad opportunities for involvement in these activities.
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Based on several randomized clinical trials, carotid revascularization has been shown to reduce future stroke risk among individuals with severe asymptomatic carotid stenosis. However, a well-recognized problem with such prophylactic intervention is the risk of periprocedural stroke, death, or myocardial infarction. If actual stroke risk with asymptomatic carotid stenosis can be reduced significantly by aggressive medical management, carotid revascularization may yield marginal benefit or even cause harm especially in those with limited life expectancy. ⋯ Others feel such conclusions cannot be made with observational data alone. In the midst of this controversy, it is important that clinicians perform carotid revascularization on a case by case basis while ensuring optimal medical management in all patients. An algorithmic approach to decision making based on available evidence will enable clinicians to personalize patient management with efficiency.