Symplicity Makes Life Difficult For Renal Denervation Programs
This article was originally published in The Gray Sheet
A big slice of the device industry, from large-cap firms to venture capitalists, is trying to understand the new reality in the wake of Medtronic’s announcement that its Symplicity hypertension trial missed its endpoint
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Industry closely scrutinized FDA's premarket review performance as the agency took steps to streamline reviews and remake the U.S. postmarket surveillance system. Meanwhile: device mega-mergers accelerated; one of the most hotly anticipated medtech innovations faltered; and national elections swept in Republican control of Congress. Here is a look back at coverage and analysis from "The Gray Sheet" on six key themes for the medical device and diagnostics industry in 2014.
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The lead investigator on the SYMPLICITY HTN-3 trial says sham-controlled trials are sometimes ethically necessary to prevent patients from undergoing ineffective treatments and warns there may be other medical devices on the market that are not as effective as previously thought.
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