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          comprehensive

          comprehensive

          author:comprehensive    Page View:444
          Blood Pressure Guidelines
          APStock

          An advisory committee to the Food and Drug Administration will convene on Tuesday to evaluate the benefits of renal denervation, a one-time surgical procedure that works to reduce blood pressure. The promise — and the potential market — is enormous, but the data on how well the procedure works remains contentious.

          The committee will evaluate data from two companies vying for market approval: ReCor Medical, a startup owned by Japanese company Otsuka Medical Devices, and device giant Medtronic, both of which have made surgical systems to treat hypertension.

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          Data from an analysis of three randomized clinical trials of ReCor Medical’s device showed a modest decrease in blood pressure after two months compared to a control group that received a placebo procedure. Medtronic’s late-stage trial showed that renal denervation reduced hypertension when measuring blood pressure in the doctor’s office, but did not show a reduction in blood pressure when patients measured it at home over 24 hours. At-home blood pressure is considered the more accurate measure, as blood pressure levels tend to artificially rise with anxiety in the clinic. Neither study presented serious safety concerns.

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