Heart Device Studies Still Leave Women Out of Equation, University of California, San Francisco (UCSF) Study

MedPageToday -- Too few clinical trials of cardiac devices adequately address safety and efficacy in women, despite long-standing requirements by the FDA to do so, a review of premarket approvals showed. Women consistently made up only about one-third of participants in clinical trials of 78 high-risk cardiovascular devices that made it to market from 2000 through 2007, reported Rita F. Redberg, MD, MSc, of the University of California San Francisco, and colleagues,

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