Further positive results for Symplicity (Medtronic) Renal Dernervation System
Medtronic, Inc. has announced one-year results from Symplicity HTN-2, the first randomized clinical trial investigating renal denervation for Resistant Hypertension, that 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 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 FDA for commercial distribution in the United States. The device has CE Mark approval in Europe.
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Egan, Brent M., et al. �Uncontrolled and Apparent Treatment Resistant Hypertension in the United States, 1988-2008.� Circulation 124. 9 (2011): 1046-1058.