Medtronic Symplicity Renal Denervation System shows significant blood pressure reduction out to three years

Medtronic announced Sunday that its 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 meeting. According to Medtronic, 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. Renal denervation therapy is a minimally invasive, catheter-based procedure that modulates the output of nerves that lie within the renal artery wall and lead into and out of the kidneys. These nerves are part of the sympathetic nervous system, which affects the major organs that are responsible for regulating blood pressure: the brain, the heart, the kidneys and the blood vessels. The Symplicity renal denervation system is not approved by the U.S. Food and Drug Administration for commercial distribution in the United States. The SYMPLICITY HTN-1 Trial involves 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, Medtronic said. There was no evidence of renal impairment, no patients were hospitalized due to hypotension, and no procedure-related serious adverse events were seen.