MMedtronic's Symplicity renal denervation system has shown sustained blood pressure reduction, with no evidence of renal impairment, at six months post treatment in patients with treatment-resistant hypertension.
Symplicity features a flexible catheter and proprietary generator, which are used to perform a procedure called renal denervation, a minimally invasive, catheter-based procedure which modulates the output of nerves that line the walls of the arteries leading to the kidneys.
The physician inserts the small, flexible catheter into the femoral artery in the upper thigh and once in place within the renal artery, the generator is activated to deliver controlled, low-power radio-frequency (RF) energy to deactivate the surrounding renal nerves.
The international multicentre prospective randomised controlled Symplicity HTN-2 trial enrolled 106 patients with treatment-resistant hypertension to evaluate the safety and effectiveness of the renal denervation system. The study showed patients who received renal denervation treatment with Symplicity experienced a mean blood pressure reduction of -28/-10 mm Hg at six months following treatment compared with baseline.
Markus Schlaich, Hypertension & Kidney Disease head at the Baker IDI Heart and Diabetes Institute in Melbourne, Australia, said the pooled analysis of controlled trial data at six months added to evidence about the safety, effectiveness and sustainability of blood pressure reductions achieved with renal denervation.
Medtronic Coronary & Renal Denervation senior vice president and president Sean Salmon said the new treatment guidance issued by the European Society of Hypertension on the use of renal denervation to treat resistant hypertension supported using technology which has demonstrated safety and effectiveness in clinical studies.
"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," Salmon added.
The six month pooled outcomes from randomised and crossover patients following renal denervation were presented at the 22nd Annual Scientific Meeting of the European Society of Hypertension.
Image: Medtronic World Headquarters, located in Fridley, Minnesota, US. Photo: Bobak Ha'Eri.