Medtronic, Inc. has taken the opportunity to announce at this week’s TCT2012, new results from Symplicity HTN-1, the longest running clinical trial investigating the safety and efficacy of renal denervation.
The new data showed patients who received renal denervation treatment with the Symplicity™ system experienced a mean blood pressure reduction of -29/-14 mm Hg [p<0.01] at 24 months (n=105).
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 study known as Symplicity HTN-1 was a series of pilots at 19 centres in Australia, Europe and the United States. The open-label cohort study enrolled 153 patients with systolic blood pressure ≥160 mm Hg while taking ≥3 antihypertensive drugs at optimal dosages, including a diuretic. Most patients are being followed to one year and a subgroup of patients is being followed semi-annually to three years post-renal denervation with the Symplicity system. It’s the ongoing data collection from these new patients that is being reported now.
The expanded two year cohort data were presented for the first time today at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
The data expand the total number of patients to nearly two times the number previously reported at 24 months (n=59) from this clinical trial. The safety of renal denervation with the Symplicity system was also maintained at 24 months.
Responder rates (defined as a ³10 mm Hg reduction) among patients completing follow–up increased from 69 percent at one month to 82 percent at 24 months. Safety follow-up at 24 months demonstrated continued stable renal function with no new episodes of hypotension, orthostasis, or renal artery stenosis related to the renal denervation procedure; adverse events due to co-morbid diseases such as infection and non-renal surgical complications were reported.
“These clinical trial results provide important evidence and confidence for physicians that renal denervation with the Symplicity system continues to be safe and effective in reducing blood pressure over time in patients with treatment-resistant hypertension, who are at high risk for various cardiovascular events,” said Markus Schlaich, M.D. F.A.H.A, professor of medicine and head of Hypertension & Kidney Disease at the, Baker IDI Heart and Diabetes Institute in Melbourne, Australia. “These data in nearly twice the number of patients previously reported at two years in this trial provide us with a better understanding of the patient response over time and add to the growing body of evidence supporting the safety and sustained blood pressure reduction of renal denervation treatment with the Symplicity system.”
Full article here.
Source: Medtronic, Inc.