Medtronic has reported six month pooled data from Symplicity HTN-2 clinical trial following renal denervation with the Symplicity renal denervation system.
The international, multi-center, prospective, randomized, controlled trial, which enrolled 106 patients, was designed to assess the safety and effectiveness of Symplicity renal denervation system in patients with treatment-resistant hypertension.
The data showed that patients 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.
Baker IDI Heart and Diabetes Institute hypertension & kidney disease associate professor Markus Schlaich said, "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."
Symplicity renal denervation system consists of a proprietary generator and flexible catheter which delivers a controlled, low-power radio-frequency (RF) energy through a proprietary algorithm, or pattern, aiming to deactivate the surrounding renal nerves.