Sanket S. Dhruva

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BACKGROUND Cardiovascular devices can have different safety and effectiveness profiles in men and women. The type and quality of sex-specific data reviewed by the Food and Drug Administration (FDA) before approval of these devices are unknown. METHODS AND RESULTS We performed a systematic review of the demographics, comments on gender bias, and analysis(More)
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)
Aortic stenosis is the most common form of valvular heart disease in the Western world and until recently, surgical aortic valve replacement has been the only treatment available for patients with this disease that has been shown to improve both symptoms and survival. Transcatheter aortic valve replacement has emerged as a new therapy for patients with(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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