Medtronic, Inc. MDT today announced
that one-year results from Symplicity HTN-2, the first randomized clinical
trial investigating renal denervation, were published online before print in
Circulation, the Journal of the American Heart Association. These data showed
patients who initially received treatment with the Symplicity(TM) renal
denervation system (n=47) sustained a significant drop in blood pressure
(-28/-10 mm Hg [p<0.001]) compared to baseline at 12 months; these 12 month
results demonstrate preservation of the benefit at six month follow-up
(-32/-12 mm Hg). No device-related serious adverse events, no late vascular
complications, and no significant decline in kidney function were reported at
12 months. The Symplicity renal denervation system is not approved by the
U.S. Food and Drug Administration (FDA) for commercial distribution in the
United States.
Also reported in the manuscript were 6 month results of 35 patients in the
control group who received renal denervation after the primary endpoint was
assessed at six months post randomization (referred to as the crossover
group). The crossover group also showed a significant drop in blood pressure
six months after the renal denervation procedure (-24/-8 mm Hg [p<0.001]).
This decrease in blood pressure is similar to the blood pressure reduction in
the initial treatment arm at 6 months.
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