24-Month Clinical Update from Symplicity HTN-2 Presented Today at the 62nd Annual Scientific Session of the American College of Cardiology

MINNEAPOLIS and SAN FRANCISCO – Medtronic, Inc. today announced 24-month data from Symplicity HTN-2, the first randomized clinical trial investigating renal denervation. Presented for the first time today at the 62nd Annual Scientific Session of the American College of Cardiology, the data show patients initially randomized to treatment with the Symplicity™ renal denervation system (n=40) sustained a significant drop in blood pressure (-29/-10 mm Hg from baseline [p<0.01]) at 24 months.

Additionally, 26 subjects in the control group who crossed-over and received renal denervation following assessment of the six-month primary endpoint (crossover group) had an average blood pressure reduction of –35/-13 mm Hg [p<0.01] at 24 months. These 24-month average blood pressure reductions demonstrate preservation of the blood pressure reduction for both groups reported previously at 6, 12, and 18-month follow-up. There were no device-related serious adverse events, no late vascular complications, and no significant decline in kidney function compared to pre-procedure values reported out to 24 months post-procedure. The Symplicity renal denervation system is only available for investigational use in the United States and Japan.

“Patients with treatment-resistant hypertension are at a significant risk for cardiovascular events, including heart attack, stroke and heart failure, making it critical that we find a new, effective and safe approach to help them achieve sustained blood pressure control,” said Professor Henry Krum, chair of medical therapeutics, professor of medicine and director of the Monash Centre of Cardiovascular Research and Education in Therapeutics, Melbourne, Australia who presented the data today at ACC.13. “These latest data add to the growing body of evidence demonstrating consistent blood pressure reduction with the Symplicity system and underscore its potential as an option for us to help our medication-refractory patients achieve better blood pressure control.”

At 24 months, pulse pressure improved significantly for patients in this analysis following treatment with the Symplicity system (-18.5 mm Hg from baseline for the initial treatment group [p<0.01]; and -22.5 mm Hg from baseline for the crossover group [p<0.01]). Pulse pressure is the numeric difference between systolic and diastolic blood pressure and is important because higher values are reported to be associated with increased cardiovascular complications, especially in older patients. Pulse pressure, as well as systolic and diastolic blood pressure, is commonly assessed when evaluating the efficacy of antihypertensive therapy.

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. The nerves passing to the kidneys 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 six years to successfully treat thousands of patients with treatment-resistant hypertension worldwide.

Source: Medtronic, Inc.