Symplicity™ Renal Denervation System: 6 Month Study Results Presented

“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.”

In short

We last covered Medtronic’s Symplicity™ renal denervation system in March here with positive coverage of two ongoing clinical trials. Now the company has announced six month pooled outcomes from randomised and crossover patients in the Symplicity HTN-2 clinical trial following renal denervation with the Symplicity™ renal denervation system showing significant, sustained blood pressure reduction in patients with treatment-resistant hypertension.

Background

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.

Medtronic says its 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 and indeed it has been been successfully used for nearly five years to treat more than 4,000 patients with treatment-resistant hypertension worldwide.

The new data, presented at the European Society of Hypertension annual meeting showed 84 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.

Clinician comments

“The Symplicity clinical program is the longest and largest clinical program of its kind evaluating renal denervation in resistant hypertension,” said Markus Schlaich, M.D., associate professor, head, Hypertension & Kidney Disease, Baker IDI Heart and Diabetes Institute in Melbourne, Australia. “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.”

Company comments

“New treatment guidance issued by the European Society of Hypertension on the use of renal denervation to treat resistant hypertension supports the use of technology that has demonstrated enduring safety and effectiveness safety in clinical studies,” said Sean Salmon, Senior Vice President and President, Coronary & Renal Denervation, Medtronic. “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.”

Source: Medtronic,Inc., Business Wire