Medtronic Inc's Symplicity Renal Denervation System Demonstrates Significant and Sustained Blood Pressure Reduction Out To Three Years

Medtronic Inc announced that the Symplicity renal denervation system provides safe, significant and sustained blood pressure reduction up to three years in patients with treatment-resistant hypertension, according to data from two clinical trials presented at the 2012 American College of Cardiology (ACC) meeting. Results from the SYMPLICITY HTN-1 trial showed sustained safety and effectiveness of renal denervation with the Symplicity system up to three years, and results from the SYMPLICITY HTN-2 trial showed safe, sustained and significant blood pressure reduction one year following the procedure. These data were presented during an oral session at ACC.12 dedicated to renal denervation (RDN) as a therapy for treatment of treatment-resistant hypertension. SYMPLICITY HTN-1 is a series of pilot studies involving 153 patients at 19 centers in Australia, Europe and the United States. Subjects in the SYMPLICITY HTN-1 trial maintained an average blood pressure reduction of -33/-19 mm Hg at 36 months (n=24) from baseline (p<.001) following treatment with the Symplicity system. An increasing proportion of patients who completed follow-up had at least a 10 mm Hg reduction in systolic blood pressure. At 6 months 71% of patients were classified as responders, which increased to 100% among the patients who completed three year follow-up. There was no evidence of renal impairment, no patients were hospitalized due to hypotension, and no procedure-related serious adverse events were seen.