Trial reports Symplicity (Medtronic) data consistent over 3 year study
Three-year data from SYMPLICITY HTN-2, the longest-running randomized, controlled clinical trial of the Symplicity Renal Denervation System, from Medtronic, in patients with Hypertension, demonstrates results consistent with data reported previously at six, 12 and 24-months of follow-up. The data show an average blood pressure reduction of -33/-14 mm Hg from baseline and an overall response rate (systolic blood pressure drop of greater than or equal to 10 mm Hg) of 85 percent for patients initially randomized to treatment with the Symplicity system and available for 36-month evaluation (n=40).
Despite a mean systolic blood pressure of 183.5 +/- 19.5 mm Hg pre-denervation, 50% of these patients achieved the goal of systolic blood pressure of less than 140 mm Hg. The safety profile of renal denervation with the Symplicity system was also maintained at three years, with no newly reported device or procedure related serious adverse events. Results were presented at the Annual Transcatheter Cardiovascular Therapeutics Symposium.