Results from registry study of Symplicity (Medtronic) confirm safety profile

The first results from the Global SYMPLICITY Registry reaffirmed the safety of the Symplicity renal denervation system, from Medtronic, in a real-world patient population. Among the 617 registry patients with follow-up information available for this first analysis, no major complications or serious adverse events related to delivery of radio frequency energy to the renal artery were reported. Of these patients, only two experienced access site vascular complications immediately post-procedure. There was a 9% incidence of renal vessel irregularity on angiography due to the application of RF energy to the vessel wall following the procedure.

Data for the secondary efficacy analysis showed renal denervation also has a significant reduction in both office and ambulatory blood pressure compared to baseline. Patients with systolic blood pressure of 180 mm Hg and diastolic blood pressure of 100 mm Hg had an average office blood pressure reduction of -30/-16 mm Hg at 6 months. Patients with a SBP 160 mm Hg had an average office blood pressure reduction of -18/-9 mm Hg. These data will be presented during an oral session at EuroPCR 2013.