SYMPLICITY HTN-1 study: RDN treatment significantly reduces blood pressure

Long-term data presented today from Ardian's SYMPLICITY HTN-1 study demonstrate that the significant reductions in blood pressure achieved using Renal Denervation (RDN) treatment are sustained through 24 months.  The data were presented at the late breaking trials session of the European Society of Hypertension (ESH) Annual Scientific meeting in Oslo, Norway.

The multicenter SYMPLICITY HTN-1 study enrolled patients from Australia, the United States and Europe who had persistently elevated blood pressure despite treatment with an average of 5.0 medications. Dr. Markus Schlaich of the Baker Heart and Diabetes Institute in Melbourne, Australia reported that the straightforward endovascular procedure safely produces a mean blood pressure reduction of -33/-15 mmHg at 24 months in the study cohort.

Both vascular and renal safety were also carefully assessed in the study and reported during the presentation. Renal vascular safety was assessed by imaging treated arteries both acutely and chronically for up to 9 months. No evidence of treatment-related abnormalities or stenoses was reported.  Kidney function was assessed with serial measures of serum creatinine and calculation of glomerular filtration rate (GFR). The mean GFR in the study cohort remained stable at latest follow-up.

Commenting on these results, Dr. Schlaich stated, "There is no question that we are having a positive impact on our patients in terms of hypertension, insulin resistance and other risk factors. The results presented today suggest that these effects might be long-lasting."

Based on pilot study results, Ardian, Inc. initiated the Symplicity HTN-2 trial, a prospective, multicenter randomized study comparing patients receiving RDN treatment to those receiving rigorous medical therapy. The trial enrolled 106 patients and completed treatments in March 2010.  An earlier presentation at the ESH meeting showed that treatment delivery was carried out with no major adverse events in all 52 patients randomized to treatment.  Primary endpoint results are expected Q4 2010.