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Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for approval (FDA, and in EU, beyond CE mark) and reimbursement

... Understanding the differences in the clinical and regulatory environments in the United States and Europe helps explain why much early device testing takes place outside of the United States, and why the introduction of new devices into clinical practice is...
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