Sanket S. Dhruva

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Medical devices have made a significant contribution to helping patients enjoy longer lives of higher quality. However, numerous weaknesses in their premarket evaluation and post-market surveillance have sometimes left patients worse off from faulty devices. For example, the Sprint Fidelis implantable cardioverter-defibrillator lead (Medtronic, Minneapolis,(More)
OBJECTIVE To investigate characteristics of clinical trials and results on safety and effectiveness reported in US Food and Drug Administration (FDA) documents for recently approved high risk cardiovascular devices compared with the characteristics and results reported in peer reviewed publications. DESIGN A search of the publicly available FDA database(More)
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