Ardian Demonstrates 2-Year Durability of Blood Pressure Reduction in Hypertension Patients Treated with Symplicity(R) Catheter System(TM)
6/21/2010 10:59:43 AM
PALO ALTO, Calif., June 21 /PRNewswire/ -- 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.
About the Symplicity®Catheter System
Ardian's 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. 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 catheterization 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 United States.
Ardian, Inc., headquartered in Palo Alto, California, is a private medical device company developing a novel catheter-based treatment for diseases related to sympathetic hyperactivity, including hypertension, chronic kidney disease, insulin resistance and heart failure. These interdependent disease states represent a significant, escalating global health issue. Ardian is the eighth company created by The Foundry, a leading medical device incubator based in Menlo Park, California. For more information, please visit www.ardian.com.
Hypertension (high blood pressure) is the leading attributable cause of death worldwide. In the United States alone, high blood pressure affects approximately 75 million people, only two-thirds of whom are treated. Close to half of all people receiving therapy for their hypertension are not achieving target blood pressure levels. Each incremental 20/10 mmHg increase of blood pressure above normal levels is associated with a doubling of cardiovascular mortality over a 10 year period.