Improved publication rates, particularly among public companies, are probably a consequence of the explicit inclusion of medical devices in the 2007 FDA Amendment Act expansion of clinicaltrials.govregistration and reporting requirements.However, recent failures of high-profile cardiovascular devices may also have led patients and physicians to more frequently ask about the evidence supporting newly approved devices, prompting publication by companies seeking clinical adoption of their products. 6Although we found that results of the vast majority of clinical studies supporting recent FDA approval of high-risk cardiovascular devices are now being made available to the clinical and research communities, efforts to improve the accessibility of results through online FDA resources and within medical device labels may still be needed to ensure dissemination of historical studies.
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Ayers et al. (2016) studied this question.