Data from a clinical trial of a hypertension therapy using a catheter indicates the device significantly reduced the treated patients’ blood pressure compared to a control group. Results of the HTN-2 trial of the Symplicity system made by Ardian Inc. of Mountain View, California were reported at the American Heart Association Scientific Sessions 2010 and published in the journal The Lancet (paid subscription required).
The study showed that, after six months, patients treated with Ardian’s device experienced an average drop in blood pressure of 32/12 mmHg (systolic/diastolic millimeters of mercury) compared to an increase in blood pressure of 1/0 mmHg in the control group of patients treated with medications alone.
The HTN-2 trial was an international, multi-center, prospective, randomized, and controlled study of the safety and effectiveness of renal denervation (RDN) in patients with uncontrolled hypertension. RDN involves inserting a small catheter in the into the femoral artery in the upper thigh and threaded into the renal artery. Once in place in the renal artery, the device delivers low-power radio frequency energy to deactivate the surrounding renal sympathetic nerves. This, in turn, reduces hyper-activation of the sympathetic nervous system, which is often the cause of chronic hypertension. The one-time procedure aims to permanently reduce blood pressure.
In the trial, 106 patients were enrolled from 24 sites. At the start, 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 RDN 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.
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