Catheter-based renal denervation for hypertension study

This study enrolled 50 patients across 5 centres in Australia and Europe, using the Symplicity® Catheter System™ to treat patients with drug-resistant hypertension.

The simple, 40-minute procedure safely produced a substantial blood pressure reduction that was sustained through the one-year follow-up.

The Symplicity Catheter System delivers radiofrequency (RF) energy from within the renal artery to block conduction in the surrounding renal nerves, thereby counteracting chronic activation of the sympathetic nervous system and lowering blood pressure.  The treatment  is performed in the catheterization laboratory using routine techniques similar to those used in renal stent procedures.  The intervention is minimally invasive and does not involve a permanent implant.

Significant blood pressure reductions of -21/-10, -22/-11, -24/-11 and -27/-17 mmHg were observed at 3, 6, 9 and 12 months, respectively. These findings suggest a durable clinical benefit following the single treatment.

Both vascular and renal safety were carefully assessed in the study.  Renal vascular safety was assessed using imaging both acutely (15 to 45 days) and chronically (6 to 9 months) with no evidence of abnormalities or stenosis at any treatment site. Kidney function was assessed with serial measures of serum creatinine and calculation of glomerular filtration rate (GFR). Again, in all instances GFR remained stable with a slight and non significant trend towards improvement.

Based on these results, prospective randomized clinical trials examining the treatment in hypertension are planned to begin this year in Europe and Australia. Trials for heart failure, cardiorenal syndrome, and chronic kidney disease are also anticipated.