Medtronic, Inc., (NYSE: MDT), announced today six month pooled outcomes from randomized and crossover patients in the Symplicity HTN-2 clinical trial following renal denervation with the Symplicity™ renal denervation system showing significant, sustained blood pressure reduction in patients with treatment-resistant hypertension. These data presented today at the European Society of Hypertension annual meeting showed patients (n=84) who received renal denervation treatment with Symplicity experienced a mean blood pressure reduction of -28/-10 mm Hg (p<0.001) at six months following treatment compared with baseline. No evidence of renal impairment was observed and renal function measures remained unchanged.
This pooled analysis included change in blood pressure at six months for all patients randomized to receive renal denervation with Symplicity at baseline (n=49), as well as patients in the control group (n=35) who met entry criteria and crossed over to the treatment group following assessment of the initial six month primary endpoint.
“The Symplicity clinical program is the longest and largest clinical program of its kind evaluating renal denervation in resistant hypertension,” said Markus Schlaich, M.D., associate professor, head, Hypertension & Kidney Disease, Baker IDI Heart and Diabetes Institute in Melbourne, Australia. “This largest pooled analysis of controlled trial data at six months adds to the growing body of clinical evidence about the safety, effectiveness and sustainability of blood pressure reductions achieved with renal denervation.”
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™ system’s catheter and proprietary generator and algorithms were carefully and specifically developed through years of clinical experience to enhance the safety and effectiveness of the renal denervation procedure. The Symplicity renal denervation system has been successfully used for nearly five years to treat more than 4,000 patients with treatment-resistant hypertension worldwide. “New treatment guidance issued by the European Society of Hypertension on the use of renal denervation to treat resistant hypertension supports the use of technology that has demonstrated enduring safety and effectiveness safety in clinical studies,” said Sean Salmon, Senior Vice President and President, Coronary & Renal Denervation, Medtronic. “We believe our Symplicity technology specifically designed for this procedure, coupled with encouraging results from the Symplicity clinical trials with three years of follow-up fall within these renal denervation treatment guidelines.”