Ardian’s Hypertension Treatment Outperforms Traditional Medical Treatment in Clinical Trial

Mountain View, CA based Ardian Inc. has announced the results of a six month study which evaluated the company’s Symplicity Catheter System for treatment of chronic drug resistant hypertension. The study compared the outcomes of patients taking three or more antihypertensive drugs to those treated with the Symplicity. The results of the study, reported in the Lancet, demonstrated that a six month treatment with Ardian’s technology proved more effective than traditional medical treatment in patients with sustained grade 2 hypertension (baseline SBP of 160 mm Hg or more). The Symplicity System is a catheter-based low-power radiofrequency (RF) renal denervation device, thought to permanently treat hypertension by reducing or eliminating the sympathetic innervation of the renal arteries, hence “reducing both the pathologic central sympathetic drive to the kidney and the renal contribution to central sympathetic hyperactivity.”
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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.