Medtronic Says 1-Year Results from Symplicity HTN-2 Randomized Controlled Trial Published in Journal of American Heart Association

Medtronic, Inc.

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.