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Resistant Hypertension Course Scientific Board’s view on Medtronic’s press release about SYMPLICITY HTN-3

In light of Medtronic’s announcement of Thursday, 9th January 2014, about SYMPLICITY HTN-3, the Resistant Hypertension Course Scientific Board shares its point of view.

Medtronic, Inc. announced yesterday that its U.S. trial in renal denervation for treatment-resistant hypertension, SYMPLICITY HTN-3, has met its primary safety endpoint, while it did not reach its primary efficacy endpoint, defined as a difference of, at least, 15 mmHg office systolic blood pressure, between sham and active renal denervation groups.

The RHC Board shares its point of view:

Resistant Hypertension Course Scientific Board’s view on Medtronic’s press release about SYMPLICITY HTN-3

Medtronic, Inc. announced yesterday that its U.S. trial in renal denervation for treatment-resistant hypertension, SYMPLICITY HTN-3, has met its primary safety endpoint, while it did not reach its primary efficacy endpoint, defined as a difference of, at least, 15 mmHg office systolic blood pressure, between sham and active renal denervation groups.

The RHC Board shares its point of view:

Final 3-year report of the Symplicity HTN-1 study is published online in the Lancet

The Symplicity HTN-1 (n=150) was the first multicenter, proof-of-concept and safety study for patients with resistant arterial hypertension (mean age 57 years) undergoing catheter-based renal denervation. Patients in the Symplicity HTN-1 study were heavily medicated, taking an average of five antihypertensive drugs, and were still poorly controlled (office blood pressure 175/98mmHg). The primary endpoint was peri-procedural and safety of the treatment (n=45) after 1 and 12 month published in 2009 at the Lancet (1).

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