Results from the Symplicity HTN-1 study were presented at the late breaking trials session of the European Society of Hypertension (ESH) Annual Scientific meeting in Oslo, Norway. These results showed that blood pressure reduction achieved by renal denervation is sustained for up to two years.
The multicentre study enrolled patients from Australia, the United States and Europe who had persistently elevated blood pressure despite treatment with an average of five medications. Renal vascular safety was assessed by imaging and treated arteries both acutely and chronically for up to nine months. 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. No evidence of treatment-related abnormalities or stenoses was reported.
Commenting on these results, Schlaich said, “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.”
Describing the Symplicity catheter’s role in the renal denervation process, Schlaich said: “We have developed a catheter-based device that actually enables us to target these renal sympathetic nerves quite specifically. They run along the renal arteries. With this catheter-based device we can target these nerves, emitting energy into the tissue which kind of silences, or destroys the nerves in the vessel wall, which then leads to a substantial reduction in blood pressure.”
Renal denervation could be a treatment option for the many patients with hypertension who do not respond to conventional drugs.
Ardian are also awaiting the results of the Symplicity HTN-2 trial, a prospective, multicentre, randomised study comparing patients receiving renal denervation treatment to those receiving rigorous medical therapy. The trial enrolled 106 patients and completed treatments in March 2010, with no major adverse events in all 52 patients randomised to treatment. Primary endpoint results are expected by the end of 2010.
Ardian receives 2010 EuroPCR Innovation Award
The annual award, recently presented at the annual EuroPCR meeting in Paris, France, recognises a technology that shows the greatest potential to change the practice of interventional medicine. Previous winners of this honour include Transcatheter Aortic Valve Implant (TAVI) technology and Bioabsorbable Stent systems.
“We are honoured to receive an award from such a prestigious group acknowledging the clinical importance of our new technology,” said Andrew Cleeland, president and CEO of Ardian.
Ardian’s Symplicity Catheter System delivers radiofrequency energy from within the renal artery to block conduction in the surrounding renal nerves, thereby counteracting chronic activation of the sympathetic nervous system. In addition to blood pressure reduction, this treatment has shown promising results for chronic kidney disease, insulin resistance and heart failure. The treatment is performed in the catheterisation laboratory using interventional techniques similar to those used in other endovascular procedures and does not involve a permanent implant. The Symplicity Catheter System has received CE mark approval in Europe but remains investigational in the USA.
