Ardian's catheter-based treatment for hypertension demonstrates blood pressure reduction
Published date : 18 November 2010
Article date : 18 November 2010
Findings reported at the American Heart Association Scientific Sessions 2010 and published in The Lancet yesterday demonstrated that the landmark Symplicity HTN-2 trial evaluating Ardian’s Symplicity® Catheter System™ met its primary endpoint.
The study showed that, after six months, patients treated with Ardian's device experienced an average drop in blood pressure of 32/12 mmHg compared to an increase in blood pressure of 1/0 mmHg in the control group of patients treated with medical therapy alone (p<0.0001).
Research has shown that each incremental 20/10 mmHg increase of blood pressure above normal levels is associated with a doubling of cardiovascular mortality over a 10 year periodi and that reducing systolic blood pressure by as little as 5 mmHg can reduce the risk of stroke by almost 30 percent.ii
“The impressive results of this study show that Ardian’s Symplicity System has the potential to become a truly revolutionary treatment,” said Murray Esler, M.D., Ph.D., principal investigator of the trial and associate director of the Baker IDI Heart and Diabetes Institute of Melbourne, Australia. “Combined with findings from the earlier Symplicity HTN-1 study, which demonstrated the safety and durability of the therapy out to two years, these results fuel our enthusiasm for the potential of this treatment to significantly impact the standard of care for the large number of patients suffering from this disease.”
The Symplicity HTN-2 trial was an international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension. One hundred-six patients were enrolled from 24 investigational sites. At baseline the randomized treatment and control patients had similar high blood pressures: 178/97 mmHg and 178/98 mmHg, respectively, despite both receiving an average daily regimen of five antihypertensive medications. After six months, the average blood pressure of the renal denervation group was reduced to 146/85 mmHg, compared to an average blood pressure of 179/98 mmHg for the control group.
The study also found that the therapy was safe, with no serious device or procedure-related events, no cardiovascular complications and no kidney-related complications.
i Lewington S., et al. Lancet. 2002;360:1903-1913.
ii Mohr, J.P., Churchill Livingstone, 2004.
iii Mathers, C., et al. World Health Organization; 2009.
