Final Clinical Outcomes from First and Longest-Running Renal Denervation Clinical Study Presented During European Society of Cardiology Congress and Accepted for Publication in The Lancet

MINNEAPOLIS AND AMSTERDAM --  Medtronic, Inc. announced today at the European Society of Cardiology (ESC) Congress the final three-year results from Symplicity HTN-1, the first and longest running clinical study investigating the safety and efficacy of renal denervation, which also have been accepted for publication in The Lancet. Eighty-eight (88) treatment-resistant hypertension patients were available for 36 month evaluations following treatment with the Symplicity(TM) renal denervation system. These 88 patients demonstrated sustained reductions in blood pressure year-over-year with an average reduction of -32/-14 mm Hg [p<0.01]. Of these 88 patients, approximately 50 percent achieved goal of a systolic blood pressure <140 mm Hg despite having a mean systolic blood pressure of 169.8 mm Hg pre-denervation. There were very few clinically significant late adverse events reported through three years of follow up.

"We are pleased to find that we're seeing sustained and significant blood pressure reductions overall in all patients who reached the three year time point following their denervation procedure.  Achieving goal of below 140 mm Hg in about half of these patients is impressive considering that these patients had very high baseline blood pressures despite being on multiple pharmaceutical agents," said Professor Henry Krum, Principal Investigator of Symplicity HTN-1 and 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 ESC. "These were patients who were out of hypertension treatment options before they received renal denervation, so reductions of blood pressure of this magnitude may dramatically decrease their risk for stroke, heart attack, heart failure and kidney disease in the years to come." 

Symplicity HTN-1 is a series of pilot studies at 19 centers in Australia, Europe and the United States. The open-label studies enrolled 153 patients with treatment-resistant hypertension, defined as having a systolic blood pressure >=160 mm Hg while taking >=3 antihypertensive drugs at optimal dosages, including a diuretic. The patients consented to be followed for either one, two, or three years after treatment with renal denervation. Follow-up is now complete for the 88 patients who were followed to three years. Symplicity HTN-1 is the largest cohort of patients with the longest follow up data for renal denervation to date.

Patients treated with renal denervation experienced consistent reductions in blood pressure regardless of advanced age, the presence of diabetes or impaired baseline renal function. Safety follow-up between 24 and 36 months demonstrated continued stable renal function; two orthostatic hypotension events in one subject resolved with medication changes, and one renal artery stenosis at 24 months, possibly related to the renal denervation procedure. Adverse events due to co-morbid diseases such as infection and non-renal surgical complications were also reported.

Source: Medtronic, Inc.