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Pivotal Renal Denervation Trial Fails to Show Efficacy in Resistant Hypertension — Physician’s First Watch
Pivotal Renal Denervation Trial Fails to Show Efficacy in Resistant Hypertension
By Larry Husten
Medtronic announced on Thursday that the SYMPLICITY HTN-3 trial of its much-anticipated renal denervation device failed to meet its primary efficacy endpoint. Renal denervation has been widely touted as a breakthrough that could dramatically lower systolic blood pressure by as much as 30 mm Hg, allowing physicians to cure the most severe form of high blood pressure, resistant hypertension.
SYMPLICITY HTN-3 met its primary safety endpoints, said Deepak Bhatt, the trial's co-principal investigator, in a Medtronic press release. "Importantly, however, the trial did not meet its primary efficacy endpoint." To demonstrate efficacy, systolic blood pressure in the treatment arm would have needed to be 10 mm Hg lower than in the control arm.
The Symplicity renal denervation system is available in Europe; it has not been approved in the U.S.
Editors' note: Adapted with permission from CardioExchange.